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The Safety And Efficacy Of A Probiotic Intervention On Lactulose Hydrogen Breath Test-Positive Patients And Related Gastrointestinal Symptoms

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later Dec 2026 → Apr 2027
See other at-risk trials from Nimble Science Ltd.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary endpoints: details revised at 1 of 1 entry Show 8 more changesShow less
    • Enrollment closed, study ongoing
    • Primary completion pushed from Dec 2026 to Apr 2027
    • Study completion pushed from Dec 2026 to Sep 2027
    • Start date: Jul 20, 2024 to Jul 10, 2024
    • Eligibility criteria expanded, about 36 words
    • Secondary endpoints: details revised at 2 of 12 entries
    • Site details revised
    • Study description expanded, about 4 words
  2. Primary and study completion dates: Dec 2025 to Dec 2026
    • Eligibility criteria expanded, about 82 words
    • Site contact updated
    • Study title expanded, about 4 words
    v6
  3. Primary completion date: Dec 2024 to Dec 2025
    • Study completion date: Feb 2025 to Dec 2025
    • Start date changed from estimate of Jul 2024 to Jul 20, 2024
    • Site contact updated
    v5
  4. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v4
  5. Study completion date: Dec 2024 to Feb 2025
    • Eligibility criteria expanded, about 143 words
    v3
  6. Start date: May 2024 to Jul 2024
    • Study sites: 2 to 1
    • Study description expanded, about 128 words
    • Eligibility criteria shortened, about 4 words
    v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this study is to test the effect of a probiotic formulation on gastrointestinal symptoms, gut and small intestine microbiota in participants suffering from small intestinal bacterial overgrowth (SIBO). Two doses of probiotic will be evaluated against placebo.
Trial Details
NCT Number NCT06317441
Lead Sponsor Nimble Science Ltd.
Collaborators: Lallemand Health Solutions
Conditions
(from sponsor)		 Small Intestinal Bacterial Overgrowth, SIBO
Related terms Dilatation, Pathologic, Gastrointestinal Diseases, Irritable Bowel Syndrome
Enrollment 105 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov