Trial Outcomes & Findings for Effect of a Low FODMAP Diet on SIBO Breath Test Positivity (NCT NCT04627727)

Last Updated: 2025-07-04

Results Overview

Number of Participants with Negative and Positive SIBO

Recruitment status

TERMINATED

Study phase

EARLY_PHASE1

Target enrollment

14 participants

Primary outcome timeframe

four weeks

Results posted on

2025-07-04

Participant milestones
Measure	Low FODMAP Diet low FODMAP diet: low FODMAP diet
Overall Study STARTED	14
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Effect of a Low FODMAP Diet on SIBO Breath Test Positivity

Baseline characteristics by cohort
Measure	SIBO Positive Patients n=14 Participants SIBO positive patients who undergo 3 weeks of Low FODMAP diet
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Sex: Female, Male Female	9 Participants n=99 Participants
Sex: Female, Male Male	5 Participants n=99 Participants
Race/Ethnicity, Customized white, non-hispanic	12 participants n=99 Participants
Race/Ethnicity, Customized asian	2 participants n=99 Participants
SIBO positive	14 Participants n=99 Participants

Timeframe: four weeks

Population: Participants with SIBO positivity, then underwent 4 weeks of LOW FODMAP diet and repeated SIBO breath test at end of study.

Number of Participants with Negative and Positive SIBO

Outcome measures
Measure	Low FODMAP Diet n=14 Participants low FODMAP diet: low FODMAP diet
SIBO Diagnosis Participants with negative SIBO Diagnosis	10 participants
SIBO Diagnosis Participants with Positive SIBO Diagnosis	4 participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

BIDMC

Phone: 617-667-2193