Trial Outcomes & Findings for INF108F in Infants With Food Protein Induced Proctocolitis (NCT NCT05793112)
NCT ID: NCT05793112
Last Updated: 2025-11-24
Results Overview
Absolute change from baseline in relative abundance of B. infantis INF108F to Study Day 28 via metagenomics results in mITT population. Unit measured: The absolute change from baseline in the percentage of sequenced reads assigned to B. infantis INF108F (calculated as value at Day 28 - value at baseline).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
20 participants
Primary outcome timeframe
Baseline to Day 28
Results posted on
2025-11-24
Participant Flow
Breastfed infants with FPIAP, w/ either grossly visible bloody stool or microscopic bloody stools, excl. other causes, will be recruited at PNW or MGH Pediatric GI clinic. They will be provided basic information about the study. We will ask potential participants to provide basic contact information and answer some study-specific questions as a pre-qualifier. Individuals who are interested to learn more will receive more details about the study, the informed consent, and study team contacts.
Participant milestones
| Measure |
INF108F
INF108F
|
Placebo
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
INF108F in Infants With Food Protein Induced Proctocolitis
Baseline characteristics by cohort
| Measure |
INF108F
n=10 Participants
INF108F
|
Placebo
n=10 Participants
Placebo
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Female
|
5 Participants
n=45 Participants
|
3 Participants
n=12929 Participants
|
8 Participants
n=6349 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=45 Participants
|
7 Participants
n=12929 Participants
|
12 Participants
n=6349 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=45 Participants
|
1 Participants
n=12929 Participants
|
3 Participants
n=6349 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=45 Participants
|
5 Participants
n=12929 Participants
|
11 Participants
n=6349 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=45 Participants
|
4 Participants
n=12929 Participants
|
6 Participants
n=6349 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=45 Participants
|
10 Participants
n=12929 Participants
|
20 Participants
n=6349 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
|
Weight at birth
|
3.18 kilograms (kg)
STANDARD_DEVIATION 0.527 • n=45 Participants
|
3.56 kilograms (kg)
STANDARD_DEVIATION 0.417 • n=12929 Participants
|
3.37 kilograms (kg)
STANDARD_DEVIATION 0.51 • n=6349 Participants
|
|
Birth Mode
Vaginal
|
8 Participants
n=45 Participants
|
6 Participants
n=12929 Participants
|
14 Participants
n=6349 Participants
|
|
Birth Mode
C-section
|
2 Participants
n=45 Participants
|
4 Participants
n=12929 Participants
|
6 Participants
n=6349 Participants
|
|
Singleton delivery
|
10 Participants
n=45 Participants
|
10 Participants
n=12929 Participants
|
20 Participants
n=6349 Participants
|
|
Delivered in a Hospital
|
10 Participants
n=45 Participants
|
10 Participants
n=12929 Participants
|
20 Participants
n=6349 Participants
|
|
Maternal antibiotic exposure during labor/delivery
Yes
|
3 Participants
n=45 Participants
|
3 Participants
n=12929 Participants
|
6 Participants
n=6349 Participants
|
|
Maternal antibiotic exposure during labor/delivery
No
|
6 Participants
n=45 Participants
|
6 Participants
n=12929 Participants
|
12 Participants
n=6349 Participants
|
|
Maternal antibiotic exposure during labor/delivery
Unknown
|
1 Participants
n=45 Participants
|
1 Participants
n=12929 Participants
|
2 Participants
n=6349 Participants
|
|
Highest education of either parent in home is Bachelor's or Advanced degree
|
10 Participants
n=45 Participants
|
10 Participants
n=12929 Participants
|
20 Participants
n=6349 Participants
|
|
Baby ever consumed infant formula
Yes
|
5 Participants
n=45 Participants
|
5 Participants
n=12929 Participants
|
10 Participants
n=6349 Participants
|
|
Baby ever consumed infant formula
No
|
5 Participants
n=45 Participants
|
5 Participants
n=12929 Participants
|
10 Participants
n=6349 Participants
|
|
Baby ever consumed infant probiotics
Yes
|
1 Participants
n=45 Participants
|
4 Participants
n=12929 Participants
|
5 Participants
n=6349 Participants
|
|
Baby ever consumed infant probiotics
No
|
9 Participants
n=45 Participants
|
6 Participants
n=12929 Participants
|
15 Participants
n=6349 Participants
|
|
Baby ever consumed solid food
Yes
|
0 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
|
Baby ever consumed solid food
No
|
10 Participants
n=45 Participants
|
10 Participants
n=12929 Participants
|
20 Participants
n=6349 Participants
|
|
Baby ever consumed iron supplements
Yes
|
0 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
|
Baby ever consumed iron supplements
No
|
10 Participants
n=45 Participants
|
10 Participants
n=12929 Participants
|
20 Participants
n=6349 Participants
|
|
Mother ever consumed medication to treat acid reflux of GERD
Yes
|
7 Participants
n=45 Participants
|
6 Participants
n=12929 Participants
|
13 Participants
n=6349 Participants
|
|
Mother ever consumed medication to treat acid reflux of GERD
No
|
3 Participants
n=45 Participants
|
4 Participants
n=12929 Participants
|
7 Participants
n=6349 Participants
|
|
Acid reflux medication taken after baby was born
|
2 Participants
n=45 Participants
|
4 Participants
n=12929 Participants
|
6 Participants
n=6349 Participants
|
|
Type of Acid Reflux medication consumed
Famotidine
|
1 Participants
n=45 Participants
|
1 Participants
n=12929 Participants
|
2 Participants
n=6349 Participants
|
|
Type of Acid Reflux medication consumed
Mylanta
|
0 Participants
n=45 Participants
|
1 Participants
n=12929 Participants
|
1 Participants
n=6349 Participants
|
|
Type of Acid Reflux medication consumed
None
|
9 Participants
n=45 Participants
|
8 Participants
n=12929 Participants
|
17 Participants
n=6349 Participants
|
|
Mother ever had any type of allergy
Yes
|
1 Participants
n=45 Participants
|
4 Participants
n=12929 Participants
|
5 Participants
n=6349 Participants
|
|
Mother ever had any type of allergy
No
|
9 Participants
n=45 Participants
|
6 Participants
n=12929 Participants
|
15 Participants
n=6349 Participants
|
|
Type of allergy (mother)
Asthma
|
0 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
|
Type of allergy (mother)
Allergic rhinitis
|
1 Participants
n=45 Participants
|
1 Participants
n=12929 Participants
|
2 Participants
n=6349 Participants
|
|
Type of allergy (mother)
Eczema
|
1 Participants
n=45 Participants
|
3 Participants
n=12929 Participants
|
4 Participants
n=6349 Participants
|
|
Type of allergy (mother)
Food allergy
|
0 Participants
n=45 Participants
|
1 Participants
n=12929 Participants
|
1 Participants
n=6349 Participants
|
|
Type of allergy (mother)
None
|
8 Participants
n=45 Participants
|
5 Participants
n=12929 Participants
|
13 Participants
n=6349 Participants
|
|
Father ever had any type of allergy
Yes
|
5 Participants
n=45 Participants
|
3 Participants
n=12929 Participants
|
8 Participants
n=6349 Participants
|
|
Father ever had any type of allergy
No
|
5 Participants
n=45 Participants
|
7 Participants
n=12929 Participants
|
12 Participants
n=6349 Participants
|
|
Type of allergy (father)
Asthma
|
2 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
2 Participants
n=6349 Participants
|
|
Type of allergy (father)
Allergic rhinitis
|
2 Participants
n=45 Participants
|
2 Participants
n=12929 Participants
|
4 Participants
n=6349 Participants
|
|
Type of allergy (father)
Eczema
|
3 Participants
n=45 Participants
|
1 Participants
n=12929 Participants
|
4 Participants
n=6349 Participants
|
|
Type of allergy (father)
Food allergy
|
3 Participants
n=45 Participants
|
1 Participants
n=12929 Participants
|
4 Participants
n=6349 Participants
|
|
Type of allergy (father)
None
|
0 Participants
n=45 Participants
|
6 Participants
n=12929 Participants
|
6 Participants
n=6349 Participants
|
|
Age, Customized
Age at Enrollment in weeks
|
9.2 Weeks
STANDARD_DEVIATION 3.29 • n=45 Participants
|
9.4 Weeks
STANDARD_DEVIATION 2.72 • n=12929 Participants
|
9.3 Weeks
STANDARD_DEVIATION 3.02 • n=6349 Participants
|
|
Age, Customized
Age at First Physical Exam in weeks
|
9.1 Weeks
STANDARD_DEVIATION 3.38 • n=45 Participants
|
9.4 Weeks
STANDARD_DEVIATION 2.27 • n=12929 Participants
|
9.25 Weeks
STANDARD_DEVIATION 2.88 • n=6349 Participants
|
|
Age, Customized
Gestational Age at Birth in weeks
|
39.55 Weeks
STANDARD_DEVIATION 0.997 • n=45 Participants
|
39.55 Weeks
STANDARD_DEVIATION 0.923 • n=12929 Participants
|
39.55 Weeks
STANDARD_DEVIATION 0.96 • n=6349 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 28Population: There will be two analysis populations defined for this study. Analysis of the primary, key secondary, and other secondary endpoints will be completed on the modified Intent-to-Treat (mITT) population. All safety-related tabulations will be based upon the Safety population. The mITT population will include all infants who are randomized and receive at least one supplementation of the intervention. Infants will be analyzed according to the group to which they are randomized.
Absolute change from baseline in relative abundance of B. infantis INF108F to Study Day 28 via metagenomics results in mITT population. Unit measured: The absolute change from baseline in the percentage of sequenced reads assigned to B. infantis INF108F (calculated as value at Day 28 - value at baseline).
Outcome measures
| Measure |
INF108F
n=9 Participants
INF108F
|
Placebo
n=8 Participants
Placebo
|
|---|---|---|
|
Changes to Gut Microbiome Composition
|
42.816 Change in %B.infantis reads (Day 28-BL)
Standard Deviation 53.236
|
-12.413 Change in %B.infantis reads (Day 28-BL)
Standard Deviation 35.104
|
SECONDARY outcome
Timeframe: Baseline to day 28Population: Analysis of the key secondary endpoints will be completed based on the modified Intent-to-Treat (mITT) population. The mITT population will include all infants who are randomized and receive at least one supplementation. Infants will be analyzed according to the group to which they are randomized.
We will collect information using questionnaires about infants' gastroesophageal reflux disease symptoms, feeding, sleep and stool frequency and consistency. The severity of infant GER will be quantified using the Infant Gastroesophageal Reflux Questionnaire (I-GERQ), with numeric scores. The minimum score is 0 and the maximum score is 25; scores \>7 provide 74% specificity and 94% sensitivity for diagnosing GERD. Higher I-GERQ scores/values are indicative of worse outcomes, worse reflux symptoms for the infant. The secondary outcome was reported as the absolute change from baseline in I-GERQ score; therefore, a higher value would be positive as the score is reduced significantly from baseline, which means reflux symptoms were improved. The sleep will be captured using Infant Sleep Questionnaire, with 0-10 scales, 0 means worst sleep and 10 means excellent sleep for quantify the quality of infant's night sleep.
Outcome measures
| Measure |
INF108F
n=10 Participants
INF108F
|
Placebo
n=10 Participants
Placebo
|
|---|---|---|
|
Changes to Clinical Symptoms of FPIAP
|
-5.5 Scores on a scale
Interval -14.0 to 3.0
|
0.0 Scores on a scale
Interval -3.0 to 1.0
|
SECONDARY outcome
Timeframe: Enrollment to Study Day 14Population: Percentage of infants with no gross/visible blood in stool on Study Day 14 via the daily log
Analysis of the key secondary endpoints will be completed based on the modified Intent-to-Treat (mITT) population. The mITT population will include all infants who are randomized and receive at least one supplementation. Infants will be analyzed according to the group to which they are randomized.
Outcome measures
| Measure |
INF108F
n=10 Participants
INF108F
|
Placebo
n=10 Participants
Placebo
|
|---|---|---|
|
Percentage of Infants With no Gross/Visible Blood in Stool on Study Day 14 Via the Daily Log
Gross/visible blood in stool on Day 14
|
0 Participants
|
2 Participants
|
|
Percentage of Infants With no Gross/Visible Blood in Stool on Study Day 14 Via the Daily Log
No gross/visible blood in stool on Day 14
|
10 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Baseline, Study Day 7, Study Day 14, Study Day 28Population: Analysis of the key secondary endpoints will be completed based on the modified Intent-to-Treat (mITT) population. The mITT population will include all infants who are randomized and receive at least one supplementation. Infants will be analyzed according to the group to which they are randomized.
Analysis of the key secondary endpoints will be completed based on the modified Intent-to-Treat (mITT) population. The mITT population will include all infants who are randomized and receive at least one supplementation. Infants will be analyzed according to the group to which they are randomized.
Outcome measures
| Measure |
INF108F
n=10 Participants
INF108F
|
Placebo
n=10 Participants
Placebo
|
|---|---|---|
|
Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log
Day 0 (Baseline) · A moderate problem
|
3 Participants
|
1 Participants
|
|
Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log
Day 0 (Baseline) · A serious problem
|
0 Participants
|
0 Participants
|
|
Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log
Day 0 (Baseline) · Missing
|
0 Participants
|
0 Participants
|
|
Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log
Day 0 (Baseline) · Not a problem at all
|
2 Participants
|
5 Participants
|
|
Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log
Day 0 (Baseline) · A very small problem
|
1 Participants
|
3 Participants
|
|
Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log
Day 0 (Baseline) · A small problem
|
4 Participants
|
1 Participants
|
|
Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log
Day 7 · Not a problem at all
|
1 Participants
|
6 Participants
|
|
Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log
Day 7 · A very small problem
|
7 Participants
|
3 Participants
|
|
Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log
Day 7 · A small problem
|
2 Participants
|
0 Participants
|
|
Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log
Day 7 · A moderate problem
|
0 Participants
|
1 Participants
|
|
Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log
Day 7 · A serious problem
|
0 Participants
|
0 Participants
|
|
Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log
Day 7 · Missing
|
0 Participants
|
0 Participants
|
|
Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log
Day 14 · Not a problem at all
|
2 Participants
|
6 Participants
|
|
Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log
Day 14 · A very small problem
|
3 Participants
|
2 Participants
|
|
Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log
Day 14 · A small problem
|
5 Participants
|
1 Participants
|
|
Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log
Day 14 · A moderate problem
|
0 Participants
|
1 Participants
|
|
Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log
Day 14 · A serious problem
|
0 Participants
|
0 Participants
|
|
Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log
Day 14 · Missing
|
0 Participants
|
0 Participants
|
|
Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log
Day 21 · Not a problem at all
|
2 Participants
|
6 Participants
|
|
Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log
Day 21 · A very small problem
|
4 Participants
|
3 Participants
|
|
Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log
Day 21 · A small problem
|
1 Participants
|
0 Participants
|
|
Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log
Day 21 · A moderate problem
|
2 Participants
|
1 Participants
|
|
Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log
Day 21 · A serious problem
|
0 Participants
|
0 Participants
|
|
Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log
Day 21 · Missing
|
1 Participants
|
0 Participants
|
|
Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log
Day 28 · Not a problem at all
|
3 Participants
|
6 Participants
|
|
Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log
Day 28 · A very small problem
|
3 Participants
|
2 Participants
|
|
Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log
Day 28 · A small problem
|
2 Participants
|
0 Participants
|
|
Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log
Day 28 · A moderate problem
|
2 Participants
|
2 Participants
|
|
Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log
Day 28 · A serious problem
|
0 Participants
|
0 Participants
|
|
Percentage of Infants Within Each Category of 'Do You Consider Your Baby's Sleep a Problem?' (Not a Problem at All, a Very Small Problem, a Small Problem, a Moderate Problem, a Serious Problem) at Baseline and Study Days 7, 14, and 28 Via the Weekly Log
Day 28 · Missing
|
0 Participants
|
0 Participants
|
Adverse Events
INF108F
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
INF108F
n=10 participants at risk
INF108F
|
Placebo
n=10 participants at risk
Placebo
|
|---|---|---|
|
Gastrointestinal disorders
Gas
|
10.0%
1/10 • Number of events 1 • From baseline to final follow-up study visit, an average of 30 days
|
0.00%
0/10 • From baseline to final follow-up study visit, an average of 30 days
|
|
Skin and subcutaneous tissue disorders
Mild eczema
|
10.0%
1/10 • Number of events 1 • From baseline to final follow-up study visit, an average of 30 days
|
0.00%
0/10 • From baseline to final follow-up study visit, an average of 30 days
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/10 • From baseline to final follow-up study visit, an average of 30 days
|
20.0%
2/10 • Number of events 2 • From baseline to final follow-up study visit, an average of 30 days
|
|
Metabolism and nutrition disorders
Failure to thrive
|
20.0%
2/10 • Number of events 3 • From baseline to final follow-up study visit, an average of 30 days
|
40.0%
4/10 • Number of events 4 • From baseline to final follow-up study visit, an average of 30 days
|
|
Gastrointestinal disorders
Colicky
|
20.0%
2/10 • Number of events 4 • From baseline to final follow-up study visit, an average of 30 days
|
20.0%
2/10 • Number of events 5 • From baseline to final follow-up study visit, an average of 30 days
|
|
Gastrointestinal disorders
Hematemesis
|
0.00%
0/10 • From baseline to final follow-up study visit, an average of 30 days
|
10.0%
1/10 • Number of events 1 • From baseline to final follow-up study visit, an average of 30 days
|
|
Gastrointestinal disorders
Hematochezia
|
0.00%
0/10 • From baseline to final follow-up study visit, an average of 30 days
|
10.0%
1/10 • Number of events 1 • From baseline to final follow-up study visit, an average of 30 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place