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Effect of a Low FODMAP Diet on SIBO Breath Test Positivity

NCT04627727 · Status: TERMINATED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2025-07-04

Study results available
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Summary

Bloating is the most common symptom associated with disorders of brain-gut interaction (i.e., functional bowel disorders) such as irritable bowel syndrome, a disorder characterized by abdominal pain and altered bowel habits which affects up to 11% of world population. A common cause of bloating is small intestinal bacterial overgrowth (SIBO), a condition defined by excessive and/or abnormal type of bacteria in the small bowel. The potential role of SIBO for irritable bowel syndrome (IBS) was initially proposed by Pimentel et al. Using lactulose breath tests (LBTs), 78% of patients with IBS were also diagnosed with SIBO. After antibiotic therapy, 48% of patients no longer met the Rome criteria for IBS. A recent systematic review and meta-analysis concluded that the prevalence of SIBO is increased in IBS.

Conditions

  • SIBO

Interventions

OTHER

low FODMAP diet

low FODMAP diet

Sponsors & Collaborators

Principal Investigators

  • Anthony Lembo, M.D · Beth Israel Deaconess Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-15
Primary Completion
2024-12-15
Completion
2024-12-15

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04627727 on ClinicalTrials.gov