IBS Personalized Diet vs. Low FODMAP Diet Randomized Control Trial

StatusRecruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary endpoint removed 2 → 1 primary endpoints
Enrollment reduced 70% 100 → 30 participants
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Record History

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  1. Primary endpoint(s) modified Show 6 more changesShow less
    • Enrollment reduced: 100 → 30 participants
    • Interventions modified
    • Eligibility criteria expanded, about 34 words
    • Secondary endpoint revised
    • Study description expanded, about 262 words
    • Study title shortened, about 2 words
  2. Enrollment target: 200 to 100v5 Show 5 more changesShow less
    • Primary completion date: Jan 2026 to Jan 2028
    • Start date: Apr 10, 2024 to May 11, 2026
    • Study completion date: Nov 2026 to Nov 2029
    • Site details revised
    • Study arms: 3 to 2
  3. Primary completion date: Nov 2024 to Jan 2026
    • Study completion date: Nov 2025 to Nov 2026
    • Site details revised
    v4
  4. Re-verified, no change to tracked fieldsv3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Nov 2023 to Apr 10, 2024
    • Study sites: 0 to 1
    v2
  6. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Irritable bowel syndrome (IBS) is considered the most common gastrointestinal disorder in humans, with an estimated global prevalence of 11%-20% of all humans. Alterations in the gut microbiome are at the center of IBS, and microbiome-induced volatile metabolites in response to dietary exposures is believed to drive a downstream impact on susceptible hosts, thereby driving the disease. However, the characteristics and functions of these metabolites remain unknown to date. This placebo-controlled interventional study examines person-specific small molecules and bacteria driving IBS and their downstream effects on the human gut epithelium.
Trial Details
NCT Number NCT05972317
Lead Sponsor Weizmann Institute of Science
Conditions
(from sponsor)		 Irritable Bowel Syndrome
Related terms Irritable Bowel Syndrome
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov