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A Clinical Trial to Investigate the Safety and Efficacy of Bloat on Gas and Bloating in Healthy Women

NCT07370740 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-01-27

No results posted yet for this study

Summary

The goal of this clinical trial is to investigate the safety and efficacy of Bloat on gas and bloating in healthy women. The main question it aims to answer is what is the change in postprandial gas and bloating from pre-dose at t = 60 mins post-dose between Bloat and placebo, as assessed by Gas and Bloating Likert scale at screening/baseline.

Participants will be asked to consume one dose of Bloat or Placebo and answer questionnaires on gas and bloating.

Conditions

  • Bloating
  • Gastrointestinal Symptoms
  • Intestinal Gas

Interventions

DIETARY_SUPPLEMENT

Bloat

Participants will be instructed to take one dose (2 capsules) 30 minutes after consumption of the entire standardized meal during the screening/baseline clinic visit.

OTHER

Placebo

Participants will be instructed to take one dose (2 capsules) 30 minutes after consumption of the entire standardized meal during the screening/baseline clinic visit

Sponsors & Collaborators

  • KGK Science Inc.

    collaborator INDUSTRY

  • Arrae

    lead INDUSTRY

Principal Investigators

  • David Crowley, MD · KGK Science Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2026-07-31
Completion
2026-07-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07370740 on ClinicalTrials.gov