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A Clinical Trial to Investigate the Safety and Efficacy of Bloat on Postprandial Bloating and Its Effects Over Time in Healthy Women

StatusRecruiting
PhaseNot applicable
SponsorArrae
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 months later Oct 2026 → Jan 2027
See other at-risk trials from Arrae

Record History

See every version on ClinicalTrials.gov ↗

  1. Recruitment opened Show 5 more changesShow less
    • Primary and study completion pushed from Oct 2026 to Jan 2027
    • Start date changed from estimate of Jun 2026 to Aug 19, 2026
    • Eligibility criteria expanded, about 36 words
    • Secondary endpoints: details revised at 8 of 8 entries
    • Site details revised
  2. Primary endpoint(s) modifiedv2 Show 5 more changesShow less
    • Primary and study completion pushed from Jul 2026 to Oct 2026
    • Start date: May 2026 to Jun 2026
    • Eligibility criteria expanded, about 30 words
    • Secondary endpoints: 7 to 8
    • Study title expanded, about 4 words
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Arrae
3 trials monitored
See 1 trial at risk
The goal of this clinical trial is to investigate the safety and efficacy of Bloat on postprandial bloating in healthy women. The main question it aims to answer is what is the difference in change in bloating from pre-dose (postprandial) at t = 60 mins post-dose (postprandial) between Bloat and placebo, as assessed by the bloating numeric rating scale at screening/baseline. Participants will be asked to consume one dose of Bloat or Placebo for 55 days, and answer questionnaires on gas, bloating, and abdominal discomfort/distension.
Trial Details
NCT Number NCT07370740
Lead Sponsor Arrae
Collaborators: KGK Science Inc.
Conditions
(from sponsor)		 Bloating, Gastrointestinal Symptoms, Intestinal Gas
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov