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NCT04627727 · ClinicalTrials.gov registry record · Early Phase 1
Effect of a Low FODMAP Diet on SIBO Breath Test Positivity
A Early Phase 1 study, sponsored by Beth Israel Deaconess Medical Center.
- Terminated
- Registry status
- Early Phase 1
- Development phase
- 14
- Enrollment target
NCT04627727: Clinical Trial Early Phase 1 study, sponsored by Beth Israel Deaconess Medical Center.
NCT04627727 is a Early Phase 1 study that was terminated before completion, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 14 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04627727, a Early Phase 1 study, was terminated before completion, sponsored by Beth Israel Deaconess Medical Center.
- TERMINATED
- Registry status
- Early Phase 1
- Development phase
- 14 participants
- Enrollment target
Study 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.
Primary Outcome
Number of Participants with Negative and Positive SIBO
Interventions
- OTHER low FODMAP diet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2020-11-15 |
| Est. Completion | 2024-12-15 |
| Phase | Early Phase 1 |
Why NCT04627727 stopped before completion
NCT04627727 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 1 intervention - of which low FODMAP diet is the first listed.
NCT04627727 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04627727 about?
NCT04627727 is a clinical study titled "Effect of a Low FODMAP Diet on SIBO Breath Test Positivity". 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 s...
What is the current status of trial NCT04627727?
This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 14 participants. The study started on 2020-11-15. Estimated completion is 2024-12-15.
What interventions are being tested in trial NCT04627727?
The interventions under investigation include: low FODMAP diet (OTHER).
Who is sponsoring clinical trial NCT04627727?
This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04627727's enrollment target sits among peer trials
14 1474th of 2000 higher than 498 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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