A Clinical Trial to Investigate the Safety and Efficacy of Bloat on Gas and Bloating in Healthy Women
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorArrae
About this trial
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.
Eligibility criteria
Qualifiers
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,
Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
Double-barrier method
Disqualifiers
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
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
Trial design
Treatments tested in this trial
- Bloat
- Placebo
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
Arrae
Lead sponsor
KGK Science Inc.
Collaborator
Source ClinicalTrials.gov