Clinical Trial

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

Not Yet Recruiting
View on ClinicalTrials.gov →
Summary
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.
Protocol Amendment History 3 changes
critical Primary endpoint(s) modified 2026-07-08
notable Primary completion pushed: 2026-07 -> 2026-10 2026-07-08
minor Completion pushed: 2026-07 -> 2026-10 2026-07-08
Trial Details
NCT Number NCT07370740
Lead Sponsor Arrae
Collaborators: KGK Science Inc.
Conditions Bloating, Gastrointestinal Symptoms, Intestinal Gas
Enrollment 100 participants
Start Date 2026-06
Primary Completion 2026-10 (estimated)
Study Completion 2026-10 (estimated)
Updated on ClinicalTrials.gov 2026-07-07