Trial Outcomes & Findings for Personalized AZithromycin/metronidAZole Therapy in Pediatric Crohn's Disease (CD) (NCT NCT04186247)
NCT ID: NCT04186247
Last Updated: 2025-06-29
Results Overview
Participants stratified based on carriage of an at-risk microbiome without need for re-induction for clinical flare (new course of nutritional therapy, need to restart steroids), steroid dependence, biologic (e.g. anti-TNF) use, and/or intestinal surgery.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
13 participants
Primary outcome timeframe
Week 52
Results posted on
2025-06-29
Participant Flow
Thirteen children were enrolled in the study to assess microbiome by Week 4. All participants received standard of care.
Of the 13 included children, 12 had microbiome data available by Week 4. One participant refused to continue SOC diet treatment and dropped out 1 week after starting. Three (23%) were predicted to be non-responders based on their baseline microbiome. Of these, 2 of 3 had a primary non-response to Standard of Care (SOC) treatment and did not reach clinical remission within 4 weeks. Ten participants were predicted to be responders. No participants were randomized.
Participant milestones
| Measure |
Standard of Care
All participants received standard of care during the first four weeks.
|
High Risk for Relapse (Group A1)
SOC induction (nutritional therapy) for up to 12 weeks, as assigned by the treating gastroenterologist prior to study entry.
Standard of Care: SOC induction therapy is nutritional therapy (Crohn's disease exclusion diet + partial enteral nutrition) for up to 12 weeks. Induction therapy is as assigned by the treating gastroenterologist prior to study entry.
|
High Risk for Relapse Standard of Care + Antibiotics (Group A2)
SOC induction (nutritional therapy) for up to 12 weeks, as assigned by the treating gastroenterologist prior to study entry.
Azithromycin (weeks 4-12)
Metronidazole (weeks 4-12)
Azithromycin: Weeks 4-12: 7.5 mg/kg azithromycin once daily (500 mg/day maximum) for five consecutive days/ week for 4 weeks, and 3 times a week for the following 4 weeks
Metronidazole: Weeks 4-12: 20 mg/kg/day of metronidazole (10 mg/kg twice daily to a maximum of 1000 mg/day) for 8 weeks
Standard of Care: SOC induction therapy is nutritional therapy (Crohn's disease exclusion diet + partial enteral nutrition) for up to 12 weeks. Induction therapy is as assigned by the treating gastroenterologist prior to study entry.
|
Normal Risk for Relapse Standard of Care (Group B)
SOC induction (nutritional therapy) for up to 12 weeks, as assigned by the treating gastroenterologist prior to study entry.
|
No Remission Independent of Microbiome + Antibiotics
SOC induction (nutritional therapy) for up to 12 weeks, as assigned by the treating gastroenterologist prior to study entry.
Azithromycin (weeks 4-12)
Metronidazole (weeks 4-12)
Azithromycin: Weeks 4-12: 7.5 mg/kg azithromycin once daily (500 mg/day maximum) for five consecutive days/ week for 4 weeks, and 3 times a week for the following 4 weeks
Metronidazole: Weeks 4-12: 20 mg/kg/day of metronidazole (10 mg/kg twice daily to a maximum of 1000 mg/day) for 8 weeks
Standard of Care: SOC induction therapy is nutritional therapy (Crohn's disease exclusion diet + partial enteral nutrition) for up to 12 weeks. Induction therapy is as assigned by the treating gastroenterologist prior to study entry.
|
|---|---|---|---|---|---|
|
Standard of Care (Week 0 to Week 4)
STARTED
|
13
|
0
|
0
|
0
|
0
|
|
Standard of Care (Week 0 to Week 4)
COMPLETED
|
11
|
0
|
0
|
0
|
0
|
|
Standard of Care (Week 0 to Week 4)
NOT COMPLETED
|
2
|
0
|
0
|
0
|
0
|
|
Microbiome Result at Week 4/5
STARTED
|
2
|
0
|
0
|
8
|
3
|
|
Microbiome Result at Week 4/5
COMPLETED
|
2
|
0
|
0
|
8
|
3
|
|
Microbiome Result at Week 4/5
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Randomization/Ongoing SOC/Antibiotics
STARTED
|
0
|
0
|
0
|
8
|
3
|
|
Randomization/Ongoing SOC/Antibiotics
COMPLETED
|
0
|
0
|
0
|
2
|
1
|
|
Randomization/Ongoing SOC/Antibiotics
NOT COMPLETED
|
0
|
0
|
0
|
6
|
2
|
Reasons for withdrawal
| Measure |
Standard of Care
All participants received standard of care during the first four weeks.
|
High Risk for Relapse (Group A1)
SOC induction (nutritional therapy) for up to 12 weeks, as assigned by the treating gastroenterologist prior to study entry.
Standard of Care: SOC induction therapy is nutritional therapy (Crohn's disease exclusion diet + partial enteral nutrition) for up to 12 weeks. Induction therapy is as assigned by the treating gastroenterologist prior to study entry.
|
High Risk for Relapse Standard of Care + Antibiotics (Group A2)
SOC induction (nutritional therapy) for up to 12 weeks, as assigned by the treating gastroenterologist prior to study entry.
Azithromycin (weeks 4-12)
Metronidazole (weeks 4-12)
Azithromycin: Weeks 4-12: 7.5 mg/kg azithromycin once daily (500 mg/day maximum) for five consecutive days/ week for 4 weeks, and 3 times a week for the following 4 weeks
Metronidazole: Weeks 4-12: 20 mg/kg/day of metronidazole (10 mg/kg twice daily to a maximum of 1000 mg/day) for 8 weeks
Standard of Care: SOC induction therapy is nutritional therapy (Crohn's disease exclusion diet + partial enteral nutrition) for up to 12 weeks. Induction therapy is as assigned by the treating gastroenterologist prior to study entry.
|
Normal Risk for Relapse Standard of Care (Group B)
SOC induction (nutritional therapy) for up to 12 weeks, as assigned by the treating gastroenterologist prior to study entry.
|
No Remission Independent of Microbiome + Antibiotics
SOC induction (nutritional therapy) for up to 12 weeks, as assigned by the treating gastroenterologist prior to study entry.
Azithromycin (weeks 4-12)
Metronidazole (weeks 4-12)
Azithromycin: Weeks 4-12: 7.5 mg/kg azithromycin once daily (500 mg/day maximum) for five consecutive days/ week for 4 weeks, and 3 times a week for the following 4 weeks
Metronidazole: Weeks 4-12: 20 mg/kg/day of metronidazole (10 mg/kg twice daily to a maximum of 1000 mg/day) for 8 weeks
Standard of Care: SOC induction therapy is nutritional therapy (Crohn's disease exclusion diet + partial enteral nutrition) for up to 12 weeks. Induction therapy is as assigned by the treating gastroenterologist prior to study entry.
|
|---|---|---|---|---|---|
|
Standard of Care (Week 0 to Week 4)
Withdrawal by Subject
|
2
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
High Risk for Relapse (Group A1)
n=1 Participants
SOC induction (nutritional therapy) for up to 12 weeks, as assigned by the treating gastroenterologist prior to study entry.
Standard of Care: SOC induction therapy is nutritional therapy (Crohn's disease exclusion diet + partial enteral nutrition) for up to 12 weeks. Induction therapy is as assigned by the treating gastroenterologist prior to study entry.
|
High Risk for Relapse Standard of Care + Antibiotics (Group A2)
n=2 Participants
SOC induction (nutritional therapy) for up to 12 weeks, as assigned by the treating gastroenterologist prior to study entry.
Azithromycin (weeks 4-12)
Metronidazole (weeks 4-12)
Azithromycin: Weeks 4-12: 7.5 mg/kg azithromycin once daily (500 mg/day maximum) for five consecutive days/ week for 4 weeks, and 3 times a week for the following 4 weeks
Metronidazole: Weeks 4-12: 20 mg/kg/day of metronidazole (10 mg/kg twice daily to a maximum of 1000 mg/day) for 8 weeks
Standard of Care: SOC induction therapy is nutritional therapy (Crohn's disease exclusion diet + partial enteral nutrition) for up to 12 weeks. Induction therapy is as assigned by the treating gastroenterologist prior to study entry.
|
Normal Risk for Relapse Standard of Care (Group B)
n=9 Participants
SOC induction (nutritional therapy) for up to 12 weeks, as assigned by the treating gastroenterologist prior to study entry.
|
No Remission Independent of Microbiome + Antibiotics
n=1 Participants
SOC induction (nutritional therapy) for up to 12 weeks, as assigned by the treating gastroenterologist prior to study entry.
Azithromycin (weeks 4-12)
Metronidazole (weeks 4-12)
Azithromycin: Weeks 4-12: 7.5 mg/kg azithromycin once daily (500 mg/day maximum) for five consecutive days/ week for 4 weeks, and 3 times a week for the following 4 weeks
Metronidazole: Weeks 4-12: 20 mg/kg/day of metronidazole (10 mg/kg twice daily to a maximum of 1000 mg/day) for 8 weeks
Standard of Care: SOC induction therapy is nutritional therapy (Crohn's disease exclusion diet + partial enteral nutrition) for up to 12 weeks. Induction therapy is as assigned by the treating gastroenterologist prior to study entry.
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=1 Participants
|
2 Participants
n=2 Participants
|
9 Participants
n=9 Participants
|
1 Participants
n=1 Participants
|
13 Participants
n=13 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=1 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=13 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=1 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=13 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=1 Participants
|
0 Participants
n=2 Participants
|
6 Participants
n=9 Participants
|
1 Participants
n=1 Participants
|
7 Participants
n=13 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=1 Participants
|
2 Participants
n=2 Participants
|
3 Participants
n=9 Participants
|
0 Participants
n=1 Participants
|
6 Participants
n=13 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Netherlands
|
1 Participants
n=1 Participants
|
2 Participants
n=2 Participants
|
9 Participants
n=9 Participants
|
1 Participants
n=1 Participants
|
13 Participants
n=13 Participants
|
PRIMARY outcome
Timeframe: Week 52Population: No children carrying an at-risk microbiome achieved remission by Week 4; therefore, no participants were eligible for randomization and thus these data were not collected. Only participants who remained in the study until Week 52 are reported. The other participants either refused to continue dietary therapy or needed additional medical therapy in the course of the 52 weeks due to disease activity.
Participants stratified based on carriage of an at-risk microbiome without need for re-induction for clinical flare (new course of nutritional therapy, need to restart steroids), steroid dependence, biologic (e.g. anti-TNF) use, and/or intestinal surgery.
Outcome measures
| Measure |
Standard of Care
n=2 Participants
SOC induction (nutritional therapy) for up to 12 weeks, as assigned by the treating gastroenterologist prior to study entry.
Standard of Care: SOC induction therapy is nutritional therapy (Crohn's disease exclusion diet + partial enteral nutrition) for up to 12 weeks. Induction therapy is as assigned by the treating gastroenterologist prior to study entry.
|
Standard of Care + Antibiotics
n=1 Participants
SOC induction (nutritional therapy) for up to 12 weeks, as assigned by the treating gastroenterologist prior to study entry.
Azithromycin (weeks 4-12)
Metronidazole (weeks 4-12)
Azithromycin: Weeks 4-12: 7.5 mg/kg azithromycin once daily (500 mg/day maximum) for five consecutive days/ week for 4 weeks, and 3 times a week for the following 4 weeks
Metronidazole: Weeks 4-12: 20 mg/kg/day of metronidazole (10 mg/kg twice daily to a maximum of 1000 mg/day) for 8 weeks
Standard of Care: SOC induction therapy is nutritional therapy (Crohn's disease exclusion diet + partial enteral nutrition) for up to 12 weeks. Induction therapy is as assigned by the treating gastroenterologist prior to study entry.
|
High Risk for Relapse Standard of Care + Antibiotics (Group A2)
SOC induction (nutritional therapy) for up to 12 weeks, as assigned by the treating gastroenterologist prior to study entry.
Azithromycin (weeks 4-12)
Metronidazole (weeks 4-12)
Azithromycin: Weeks 4-12: 7.5 mg/kg azithromycin once daily (500 mg/day maximum) for five consecutive days/ week for 4 weeks, and 3 times a week for the following 4 weeks
Metronidazole: Weeks 4-12: 20 mg/kg/day of metronidazole (10 mg/kg twice daily to a maximum of 1000 mg/day) for 8 weeks
Standard of Care: SOC induction therapy is nutritional therapy (Crohn's disease exclusion diet + partial enteral nutrition) for up to 12 weeks. Induction therapy is as assigned by the treating gastroenterologist prior to study entry.
|
Normal Risk for Relapse Standard of Care (Group B)
SOC induction (nutritional therapy) for up to 12 weeks, as assigned by the treating gastroenterologist prior to study entry.
|
No Remission Independent of Microbiome + Antibiotics
SOC induction (nutritional therapy) for up to 12 weeks, as assigned by the treating gastroenterologist prior to study entry.
Azithromycin (weeks 4-12)
Metronidazole (weeks 4-12)
Azithromycin: Weeks 4-12: 7.5 mg/kg azithromycin once daily (500 mg/day maximum) for five consecutive days/ week for 4 weeks, and 3 times a week for the following 4 weeks
Metronidazole: Weeks 4-12: 20 mg/kg/day of metronidazole (10 mg/kg twice daily to a maximum of 1000 mg/day) for 8 weeks
Standard of Care: SOC induction therapy is nutritional therapy (Crohn's disease exclusion diet + partial enteral nutrition) for up to 12 weeks. Induction therapy is as assigned by the treating gastroenterologist prior to study entry.
|
|---|---|---|---|---|---|
|
Number of Participants With Sustained Remission
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Week 4/5Population: Two participants provided microbiome data at Baseline but did not continue after Week 1. No participants were randomized into Group A1 or Group A2. Eight participants continued SOC in Group B and three participants were eligible for antibiotics based on microbiome data and not achieving remission in Group C (two participants received antibiotics).
The number of participants with microbiome data available at Week 4/5.
Outcome measures
| Measure |
Standard of Care
n=2 Participants
SOC induction (nutritional therapy) for up to 12 weeks, as assigned by the treating gastroenterologist prior to study entry.
Standard of Care: SOC induction therapy is nutritional therapy (Crohn's disease exclusion diet + partial enteral nutrition) for up to 12 weeks. Induction therapy is as assigned by the treating gastroenterologist prior to study entry.
|
Standard of Care + Antibiotics
SOC induction (nutritional therapy) for up to 12 weeks, as assigned by the treating gastroenterologist prior to study entry.
Azithromycin (weeks 4-12)
Metronidazole (weeks 4-12)
Azithromycin: Weeks 4-12: 7.5 mg/kg azithromycin once daily (500 mg/day maximum) for five consecutive days/ week for 4 weeks, and 3 times a week for the following 4 weeks
Metronidazole: Weeks 4-12: 20 mg/kg/day of metronidazole (10 mg/kg twice daily to a maximum of 1000 mg/day) for 8 weeks
Standard of Care: SOC induction therapy is nutritional therapy (Crohn's disease exclusion diet + partial enteral nutrition) for up to 12 weeks. Induction therapy is as assigned by the treating gastroenterologist prior to study entry.
|
High Risk for Relapse Standard of Care + Antibiotics (Group A2)
SOC induction (nutritional therapy) for up to 12 weeks, as assigned by the treating gastroenterologist prior to study entry.
Azithromycin (weeks 4-12)
Metronidazole (weeks 4-12)
Azithromycin: Weeks 4-12: 7.5 mg/kg azithromycin once daily (500 mg/day maximum) for five consecutive days/ week for 4 weeks, and 3 times a week for the following 4 weeks
Metronidazole: Weeks 4-12: 20 mg/kg/day of metronidazole (10 mg/kg twice daily to a maximum of 1000 mg/day) for 8 weeks
Standard of Care: SOC induction therapy is nutritional therapy (Crohn's disease exclusion diet + partial enteral nutrition) for up to 12 weeks. Induction therapy is as assigned by the treating gastroenterologist prior to study entry.
|
Normal Risk for Relapse Standard of Care (Group B)
n=8 Participants
SOC induction (nutritional therapy) for up to 12 weeks, as assigned by the treating gastroenterologist prior to study entry.
|
No Remission Independent of Microbiome + Antibiotics
n=3 Participants
SOC induction (nutritional therapy) for up to 12 weeks, as assigned by the treating gastroenterologist prior to study entry.
Azithromycin (weeks 4-12)
Metronidazole (weeks 4-12)
Azithromycin: Weeks 4-12: 7.5 mg/kg azithromycin once daily (500 mg/day maximum) for five consecutive days/ week for 4 weeks, and 3 times a week for the following 4 weeks
Metronidazole: Weeks 4-12: 20 mg/kg/day of metronidazole (10 mg/kg twice daily to a maximum of 1000 mg/day) for 8 weeks
Standard of Care: SOC induction therapy is nutritional therapy (Crohn's disease exclusion diet + partial enteral nutrition) for up to 12 weeks. Induction therapy is as assigned by the treating gastroenterologist prior to study entry.
|
|---|---|---|---|---|---|
|
Feasibility of Multinational Microbiome-randomized Trial
|
2 Participants
|
—
|
—
|
8 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Week 52Population: No children carrying an at-risk microbiome achieved remission by Week 4; therefore, no participants were eligible for randomization and thus these data were not collected. Only 3 participants were maintained in the study until Week 52, the other participants either refused to continue dietary therapy or needed additional medical therapy in the course of the 52 weeks due to disease activity.
Pediatric Crohn's Disease Activity Index (PCDAI) is an index used to measure disease activity of pediatric patients with Crohn's Disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, examination of abdomen, perirectal disease, and extraintestinal manifestations. Scores range from 0 to 100, with higher scores indicating greater disease activity.
Outcome measures
| Measure |
Standard of Care
n=2 Participants
SOC induction (nutritional therapy) for up to 12 weeks, as assigned by the treating gastroenterologist prior to study entry.
Standard of Care: SOC induction therapy is nutritional therapy (Crohn's disease exclusion diet + partial enteral nutrition) for up to 12 weeks. Induction therapy is as assigned by the treating gastroenterologist prior to study entry.
|
Standard of Care + Antibiotics
n=1 Participants
SOC induction (nutritional therapy) for up to 12 weeks, as assigned by the treating gastroenterologist prior to study entry.
Azithromycin (weeks 4-12)
Metronidazole (weeks 4-12)
Azithromycin: Weeks 4-12: 7.5 mg/kg azithromycin once daily (500 mg/day maximum) for five consecutive days/ week for 4 weeks, and 3 times a week for the following 4 weeks
Metronidazole: Weeks 4-12: 20 mg/kg/day of metronidazole (10 mg/kg twice daily to a maximum of 1000 mg/day) for 8 weeks
Standard of Care: SOC induction therapy is nutritional therapy (Crohn's disease exclusion diet + partial enteral nutrition) for up to 12 weeks. Induction therapy is as assigned by the treating gastroenterologist prior to study entry.
|
High Risk for Relapse Standard of Care + Antibiotics (Group A2)
SOC induction (nutritional therapy) for up to 12 weeks, as assigned by the treating gastroenterologist prior to study entry.
Azithromycin (weeks 4-12)
Metronidazole (weeks 4-12)
Azithromycin: Weeks 4-12: 7.5 mg/kg azithromycin once daily (500 mg/day maximum) for five consecutive days/ week for 4 weeks, and 3 times a week for the following 4 weeks
Metronidazole: Weeks 4-12: 20 mg/kg/day of metronidazole (10 mg/kg twice daily to a maximum of 1000 mg/day) for 8 weeks
Standard of Care: SOC induction therapy is nutritional therapy (Crohn's disease exclusion diet + partial enteral nutrition) for up to 12 weeks. Induction therapy is as assigned by the treating gastroenterologist prior to study entry.
|
Normal Risk for Relapse Standard of Care (Group B)
SOC induction (nutritional therapy) for up to 12 weeks, as assigned by the treating gastroenterologist prior to study entry.
|
No Remission Independent of Microbiome + Antibiotics
SOC induction (nutritional therapy) for up to 12 weeks, as assigned by the treating gastroenterologist prior to study entry.
Azithromycin (weeks 4-12)
Metronidazole (weeks 4-12)
Azithromycin: Weeks 4-12: 7.5 mg/kg azithromycin once daily (500 mg/day maximum) for five consecutive days/ week for 4 weeks, and 3 times a week for the following 4 weeks
Metronidazole: Weeks 4-12: 20 mg/kg/day of metronidazole (10 mg/kg twice daily to a maximum of 1000 mg/day) for 8 weeks
Standard of Care: SOC induction therapy is nutritional therapy (Crohn's disease exclusion diet + partial enteral nutrition) for up to 12 weeks. Induction therapy is as assigned by the treating gastroenterologist prior to study entry.
|
|---|---|---|---|---|---|
|
Number of Participants With Normal Pediatric Crohn's Disease Activity Index (PCDAI) Score at Week 52
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 52Population: No children carrying an at-risk microbiome achieved remission by Week 4; therefore, no participants were eligible for randomization and thus these data were not collected. Only 3 participants were maintained in the study until Week 52, the other participants either refused to continue dietary therapy or needed additional medical therapy in the course of the 52 weeks due to disease activity.
Fecal calprotectin is a non-invasive surrogate protein marker for bowel inflammation. The normal range is \<200 mcg/g.
Outcome measures
| Measure |
Standard of Care
n=2 Participants
SOC induction (nutritional therapy) for up to 12 weeks, as assigned by the treating gastroenterologist prior to study entry.
Standard of Care: SOC induction therapy is nutritional therapy (Crohn's disease exclusion diet + partial enteral nutrition) for up to 12 weeks. Induction therapy is as assigned by the treating gastroenterologist prior to study entry.
|
Standard of Care + Antibiotics
n=1 Participants
SOC induction (nutritional therapy) for up to 12 weeks, as assigned by the treating gastroenterologist prior to study entry.
Azithromycin (weeks 4-12)
Metronidazole (weeks 4-12)
Azithromycin: Weeks 4-12: 7.5 mg/kg azithromycin once daily (500 mg/day maximum) for five consecutive days/ week for 4 weeks, and 3 times a week for the following 4 weeks
Metronidazole: Weeks 4-12: 20 mg/kg/day of metronidazole (10 mg/kg twice daily to a maximum of 1000 mg/day) for 8 weeks
Standard of Care: SOC induction therapy is nutritional therapy (Crohn's disease exclusion diet + partial enteral nutrition) for up to 12 weeks. Induction therapy is as assigned by the treating gastroenterologist prior to study entry.
|
High Risk for Relapse Standard of Care + Antibiotics (Group A2)
SOC induction (nutritional therapy) for up to 12 weeks, as assigned by the treating gastroenterologist prior to study entry.
Azithromycin (weeks 4-12)
Metronidazole (weeks 4-12)
Azithromycin: Weeks 4-12: 7.5 mg/kg azithromycin once daily (500 mg/day maximum) for five consecutive days/ week for 4 weeks, and 3 times a week for the following 4 weeks
Metronidazole: Weeks 4-12: 20 mg/kg/day of metronidazole (10 mg/kg twice daily to a maximum of 1000 mg/day) for 8 weeks
Standard of Care: SOC induction therapy is nutritional therapy (Crohn's disease exclusion diet + partial enteral nutrition) for up to 12 weeks. Induction therapy is as assigned by the treating gastroenterologist prior to study entry.
|
Normal Risk for Relapse Standard of Care (Group B)
SOC induction (nutritional therapy) for up to 12 weeks, as assigned by the treating gastroenterologist prior to study entry.
|
No Remission Independent of Microbiome + Antibiotics
SOC induction (nutritional therapy) for up to 12 weeks, as assigned by the treating gastroenterologist prior to study entry.
Azithromycin (weeks 4-12)
Metronidazole (weeks 4-12)
Azithromycin: Weeks 4-12: 7.5 mg/kg azithromycin once daily (500 mg/day maximum) for five consecutive days/ week for 4 weeks, and 3 times a week for the following 4 weeks
Metronidazole: Weeks 4-12: 20 mg/kg/day of metronidazole (10 mg/kg twice daily to a maximum of 1000 mg/day) for 8 weeks
Standard of Care: SOC induction therapy is nutritional therapy (Crohn's disease exclusion diet + partial enteral nutrition) for up to 12 weeks. Induction therapy is as assigned by the treating gastroenterologist prior to study entry.
|
|---|---|---|---|---|---|
|
Number of Participants With Normal Fecal Calprotectin Levels in Stool at Week 52
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 52Population: No children carrying an at-risk microbiome achieved remission by Week 4; therefore, no participants were eligible for randomization and thus these data were not collected. Only 3 participants were maintained in the study until Week 52, the other participants either refused to continue dietary therapy or needed additional medical therapy in the course of the 52 weeks due to disease activity.
CRP is a blood protein marker of inflammation. CRP levels are classified as 'normal/low' or 'elevated/high' based on standard laboratory reference ranges.
Outcome measures
| Measure |
Standard of Care
n=2 Participants
SOC induction (nutritional therapy) for up to 12 weeks, as assigned by the treating gastroenterologist prior to study entry.
Standard of Care: SOC induction therapy is nutritional therapy (Crohn's disease exclusion diet + partial enteral nutrition) for up to 12 weeks. Induction therapy is as assigned by the treating gastroenterologist prior to study entry.
|
Standard of Care + Antibiotics
n=1 Participants
SOC induction (nutritional therapy) for up to 12 weeks, as assigned by the treating gastroenterologist prior to study entry.
Azithromycin (weeks 4-12)
Metronidazole (weeks 4-12)
Azithromycin: Weeks 4-12: 7.5 mg/kg azithromycin once daily (500 mg/day maximum) for five consecutive days/ week for 4 weeks, and 3 times a week for the following 4 weeks
Metronidazole: Weeks 4-12: 20 mg/kg/day of metronidazole (10 mg/kg twice daily to a maximum of 1000 mg/day) for 8 weeks
Standard of Care: SOC induction therapy is nutritional therapy (Crohn's disease exclusion diet + partial enteral nutrition) for up to 12 weeks. Induction therapy is as assigned by the treating gastroenterologist prior to study entry.
|
High Risk for Relapse Standard of Care + Antibiotics (Group A2)
SOC induction (nutritional therapy) for up to 12 weeks, as assigned by the treating gastroenterologist prior to study entry.
Azithromycin (weeks 4-12)
Metronidazole (weeks 4-12)
Azithromycin: Weeks 4-12: 7.5 mg/kg azithromycin once daily (500 mg/day maximum) for five consecutive days/ week for 4 weeks, and 3 times a week for the following 4 weeks
Metronidazole: Weeks 4-12: 20 mg/kg/day of metronidazole (10 mg/kg twice daily to a maximum of 1000 mg/day) for 8 weeks
Standard of Care: SOC induction therapy is nutritional therapy (Crohn's disease exclusion diet + partial enteral nutrition) for up to 12 weeks. Induction therapy is as assigned by the treating gastroenterologist prior to study entry.
|
Normal Risk for Relapse Standard of Care (Group B)
SOC induction (nutritional therapy) for up to 12 weeks, as assigned by the treating gastroenterologist prior to study entry.
|
No Remission Independent of Microbiome + Antibiotics
SOC induction (nutritional therapy) for up to 12 weeks, as assigned by the treating gastroenterologist prior to study entry.
Azithromycin (weeks 4-12)
Metronidazole (weeks 4-12)
Azithromycin: Weeks 4-12: 7.5 mg/kg azithromycin once daily (500 mg/day maximum) for five consecutive days/ week for 4 weeks, and 3 times a week for the following 4 weeks
Metronidazole: Weeks 4-12: 20 mg/kg/day of metronidazole (10 mg/kg twice daily to a maximum of 1000 mg/day) for 8 weeks
Standard of Care: SOC induction therapy is nutritional therapy (Crohn's disease exclusion diet + partial enteral nutrition) for up to 12 weeks. Induction therapy is as assigned by the treating gastroenterologist prior to study entry.
|
|---|---|---|---|---|---|
|
Number of Participants With Normal C-Reactive Protein (CRP) Levels in Blood at Week 52
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 52Population: No children carrying an at-risk microbiome achieved remission by Week 4. Consequently, no participants were eligible for randomization, and these data were not collected. Additionally, no questionnaires were completed at Week 52 for any participants. Although three children continued participation through Week 52, they were not asked to complete the IMPACT-III questionnaire after the DSMB decision to stop the study.
The IMPACT III questionnaire is a 35-item assessment of health-related quality of life in patients with inflammatory bowel disease (Crohn's disease \[CD\] or ulcerative colitis). In this study, participants aged 9 and older will complete this questionnaire at week 0, 12, 24, and 52. Participants mark an option from 1 to 5 for each item.The total scores range from 35 to 175, with higher scores representing a better quality of life.
Outcome measures
Outcome data not reported
Adverse Events
High Risk for Relapse (Group A1)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
High Risk for Relapse Standard of Care + Antibiotics (Group A2)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Normal Risk for Relapse Standard of Care (Group B)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
No Remission Independent of Microbiome + Antibiotics (Group C)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
High Risk for Relapse (Group A1)
n=1 participants at risk
SOC induction (nutritional therapy) for up to 12 weeks, as assigned by the treating gastroenterologist prior to study entry.
Standard of Care: SOC induction therapy is nutritional therapy (Crohn's disease exclusion diet + partial enteral nutrition) for up to 12 weeks. Induction therapy is as assigned by the treating gastroenterologist prior to study entry.
|
High Risk for Relapse Standard of Care + Antibiotics (Group A2)
n=2 participants at risk
SOC induction (nutritional therapy) for up to 12 weeks, as assigned by the treating gastroenterologist prior to study entry.
Azithromycin (weeks 4-12) Metronidazole (weeks 4-12) Azithromycin: Weeks 4-12: 7.5 mg/kg azithromycin once daily (500 mg/day maximum) for five consecutive days/ week for 4 weeks, and 3 times a week for the following 4 weeks Metronidazole: Weeks 4-12: 20 mg/kg/day of metronidazole (10 mg/kg twice daily to a maximum of 1000 mg/day) for 8 weeks Standard of Care: SOC induction therapy is nutritional therapy (Crohn's disease exclusion diet + partial enteral nutrition) for up to 12 weeks. Induction therapy is as assigned by the treating gastroenterologist prior to study entry.
|
Normal Risk for Relapse Standard of Care (Group B)
n=9 participants at risk
SOC induction (nutritional therapy) for up to 12 weeks, as assigned by the treating gastroenterologist prior to study entry.
|
No Remission Independent of Microbiome + Antibiotics (Group C)
n=1 participants at risk
SOC induction (nutritional therapy) for up to 12 weeks, as assigned by the treating gastroenterologist prior to study entry.
Azithromycin (weeks 4-12) Metronidazole (weeks 4-12) Azithromycin: Weeks 4-12: 7.5 mg/kg azithromycin once daily (500 mg/day maximum) for five consecutive days/ week for 4 weeks, and 3 times a week for the following 4 weeks Metronidazole: Weeks 4-12: 20 mg/kg/day of metronidazole (10 mg/kg twice daily to a maximum of 1000 mg/day) for 8 weeks Standard of Care: SOC induction therapy is nutritional therapy (Crohn's disease exclusion diet + partial enteral nutrition) for up to 12 weeks. Induction therapy is as assigned by the treating gastroenterologist prior to study entry.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/1 • From the time of signing informed consent until study conclusion (up to 52 weeks).
|
0.00%
0/2 • From the time of signing informed consent until study conclusion (up to 52 weeks).
|
11.1%
1/9 • Number of events 1 • From the time of signing informed consent until study conclusion (up to 52 weeks).
|
100.0%
1/1 • Number of events 1 • From the time of signing informed consent until study conclusion (up to 52 weeks).
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • From the time of signing informed consent until study conclusion (up to 52 weeks).
|
0.00%
0/2 • From the time of signing informed consent until study conclusion (up to 52 weeks).
|
0.00%
0/9 • From the time of signing informed consent until study conclusion (up to 52 weeks).
|
100.0%
1/1 • Number of events 1 • From the time of signing informed consent until study conclusion (up to 52 weeks).
|
|
Nervous system disorders
Nausea
|
0.00%
0/1 • From the time of signing informed consent until study conclusion (up to 52 weeks).
|
0.00%
0/2 • From the time of signing informed consent until study conclusion (up to 52 weeks).
|
11.1%
1/9 • Number of events 1 • From the time of signing informed consent until study conclusion (up to 52 weeks).
|
0.00%
0/1 • From the time of signing informed consent until study conclusion (up to 52 weeks).
|
|
Gastrointestinal disorders
Change in taste
|
0.00%
0/1 • From the time of signing informed consent until study conclusion (up to 52 weeks).
|
50.0%
1/2 • Number of events 1 • From the time of signing informed consent until study conclusion (up to 52 weeks).
|
0.00%
0/9 • From the time of signing informed consent until study conclusion (up to 52 weeks).
|
100.0%
1/1 • Number of events 1 • From the time of signing informed consent until study conclusion (up to 52 weeks).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1 • From the time of signing informed consent until study conclusion (up to 52 weeks).
|
50.0%
1/2 • Number of events 1 • From the time of signing informed consent until study conclusion (up to 52 weeks).
|
0.00%
0/9 • From the time of signing informed consent until study conclusion (up to 52 weeks).
|
100.0%
1/1 • Number of events 1 • From the time of signing informed consent until study conclusion (up to 52 weeks).
|
|
Gastrointestinal disorders
Elevated Liver Enzymes
|
0.00%
0/1 • From the time of signing informed consent until study conclusion (up to 52 weeks).
|
0.00%
0/2 • From the time of signing informed consent until study conclusion (up to 52 weeks).
|
11.1%
1/9 • Number of events 1 • From the time of signing informed consent until study conclusion (up to 52 weeks).
|
0.00%
0/1 • From the time of signing informed consent until study conclusion (up to 52 weeks).
|
|
Gastrointestinal disorders
Dilated Bile Duct
|
0.00%
0/1 • From the time of signing informed consent until study conclusion (up to 52 weeks).
|
0.00%
0/2 • From the time of signing informed consent until study conclusion (up to 52 weeks).
|
11.1%
1/9 • Number of events 1 • From the time of signing informed consent until study conclusion (up to 52 weeks).
|
0.00%
0/1 • From the time of signing informed consent until study conclusion (up to 52 weeks).
|
|
Musculoskeletal and connective tissue disorders
Limb Pain
|
0.00%
0/1 • From the time of signing informed consent until study conclusion (up to 52 weeks).
|
0.00%
0/2 • From the time of signing informed consent until study conclusion (up to 52 weeks).
|
11.1%
1/9 • Number of events 1 • From the time of signing informed consent until study conclusion (up to 52 weeks).
|
0.00%
0/1 • From the time of signing informed consent until study conclusion (up to 52 weeks).
|
Additional Information
Johan Van Limbergen, MD, PhD
Amsterdam University Medical Center
Phone: +31-20 566 9111
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place