Trial Outcomes & Findings for Is Chronic Abdominal Pain in Pediatric Patients Due to Small Intestinal Bacterial Overgrowth? (NCT NCT00619970)
NCT ID: NCT00619970
Last Updated: 2017-02-16
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
115 participants
Primary outcome timeframe
upon enrollment
Results posted on
2017-02-16
Participant Flow
Participant milestones
| Measure |
Healthy Control
Healthy controls
|
Children Receiving Rifaximin
2/3 Patients with CAP
|
Children Receiving Placebo
1/3 patients with CAP
|
|---|---|---|---|
|
Overall Study
STARTED
|
40
|
49
|
26
|
|
Overall Study
COMPLETED
|
40
|
46
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Is Chronic Abdominal Pain in Pediatric Patients Due to Small Intestinal Bacterial Overgrowth?
Baseline characteristics by cohort
| Measure |
Healthy Control
n=40 Participants
Healthy controls
|
Children Receiving Rifaximin
n=49 Participants
2/3 Patients with CAP
|
Children Receiving Placebo
n=26 Participants
1/3 patients with CAP
|
Total
n=115 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
40 Participants
n=93 Participants
|
49 Participants
n=4 Participants
|
26 Participants
n=27 Participants
|
115 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=93 Participants
|
37 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
80 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
35 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=93 Participants
|
49 participants
n=4 Participants
|
26 participants
n=27 Participants
|
115 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: upon enrollmentOutcome measures
| Measure |
Healthy Control
n=40 Participants
Healthy controls
|
Children Receiving Rifaximin
n=49 Participants
2/3 Patients with CAP
|
Children Receiving Placebo
n=26 Participants
1/3 patients with CAP
|
|---|---|---|---|
|
The Number of Participants at Baseline With SIBO
|
14 Participants
|
44 Participants
|
24 Participants
|
PRIMARY outcome
Timeframe: baseline (week 0) and at 2 weeks post treatmentPopulation: 1 patient from the treatment group withdrew from the study. Four additional children, 2 from the treatment group and 2 from the placebo group, did not show up for their follow up breath test
Outcome measures
| Measure |
Healthy Control
n=49 Participants
Healthy controls
|
Children Receiving Rifaximin
n=26 Participants
2/3 Patients with CAP
|
Children Receiving Placebo
1/3 patients with CAP
|
|---|---|---|---|
|
Number of Participants With SIBO at Baseline (Week 0) and at 2 Week Post Treatment
At baseline
|
44 Participants
|
24 Participants
|
—
|
|
Number of Participants With SIBO at Baseline (Week 0) and at 2 Week Post Treatment
2 weeks
|
37 Participants
|
19 Participants
|
—
|
Adverse Events
Healthy Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Children Receiving Rifaximin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Children Receiving Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place