A Clinical Trial to Investigate the Safety and Efficacy of Bloat on Gas and Bloating in Healthy W… (NCT07370740) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Clinical Trial to Investigate the Safety and Efficacy of Bloat on Gas and Bloating in Healthy Women
Canada100 participantsStarted 2026-05
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexFEMALE
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Inclusion criteria
✓. Females aged 18-65 years, inclusive
✓. Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least one year prior to screening Or,
✓. Recurrent bloating and/or distension occurring on average at least one day per week which predominates over other GI symptoms as assessed by the QI
✓. Experiences significant gas and bloating after consumption of the standardized meal provided at screening/baseline, as assessed by a score of 0 (absent) or 1 (mild) pre-meal and a score of 2 (moderate) or 3 (severe) post-meal
✓. Agrees to maintain current lifestyle habits (diet, physical activity, medications, supplements, and sleep) as much as possible throughout the study
✓. Provided voluntary, written, informed consent to participate in the study
✓. Healthy as determined by medical history as assessed by Qualified Investigator
Exclusion criteria
✕. Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
✕. Participants residing in the same household as another study participant unless they are enrolled consecutively (e.g. not actively enrolled at the same time)
✕. Allergy, sensitivity, intolerance, or dietary restriction preventing consumption of IP, placebo, or standardized meal ingredients
What they're measuring
1
The difference in change in postprandial gas and bloating from pre-dose at t = 60 mins post-dose between Bloat and placebo
✕. Current or history of any significant diseases of the GI tract or digestive disorders (e.g., irritable bowel syndrome, celiac disease, inflammatory bowel disease, functional constipation, gastroesophageal reflux disease, being treated within the past year for H. pylori infection or gastric ulcer) as assessed by the QI
✕. Unstable metabolic disease or chronic diseases as assessed by the QI
✕. Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
✕. Type I or Type II diabetes
✕. Significant cardiovascular event in the past 6 months. Participants with no significant cardiovascular event on stable medication may be included after assessment by the QI on a case-by-case basis