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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

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

Last updated 2026-07-07

No results posted yet for this study

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.

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 with water during the screening/baseline clinic visit (Day 1). Participants will continue taking one dose daily, with water after dinner, for a total of 55 days. Participants will be advised to take the product at least two hours before or two hours after regular medication.

OTHER

Placebo

Participants will be instructed to take one dose (2 capsules) 30 minutes after consumption of the entire standardized meal with water during the screening/baseline clinic visit (Day 1). Participants will continue taking one dose daily, with water after dinner, for a total of 55 days. Participants will be advised to take the product at least two hours before or two hours after regular medication.

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
2026-06-30
Primary Completion
2026-10-31
Completion
2026-10-31

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