Study to Evaluate the Efficacy of Arrae's Bloat & Calm Alchemy Capsules to Reduce Bloating, Heart… (NCT05197413) | Clinical Trial Compass
CompletedNot Applicable
Study to Evaluate the Efficacy of Arrae's Bloat & Calm Alchemy Capsules to Reduce Bloating, Heartburn and Gas, and Alleviate the Intensity of IBS Symptoms
United States35 participantsStarted 2021-09-01
Plain-language summary
This is an open-label observational crossover trial to study the efficacy of a commercial dietary supplement and its effect on common symptoms of IBS (such as bloating, gas, heartburn, and other symptoms).
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* Female over 18 years old
* Self-reported (undiagnosed) IBS symptoms, such as self-reported abdominal pain, gas production and bloating after meals, heartburn after meals
* Must be in good health (don't report any medical conditions asked in the screening questionnaire)
* Following a stable, consistent diet regimen
* Agree to refrain from any lifestyle changes that may affect their GI tract and IBS symptoms for the duration of the study
* May have self-reported sleep issues
* May have self-reported mild anxiety/depression
* May have self-reported occasional panic attacks
Exclusion Criteria:
* Prior prescriptions for IBS
* Current IBS treatment (e.g. proton pump inhibitors, laxatives)
* Follow an extreme diet intervention
* Experienced severe weight loss in the past 3 months prior to study participation
* Antibiotic usage within 3 months prior of study participation
* Usage any medication or herbal remedies which can affect the GI tract
* Food intolerances/allergies
* Pineapple sensitivity/allergy
* Taking cortisol lowering prescription medication
* Has any of the following medical conditions:
History of GI tract cancers Celiac disease / gluten intolerance GI bleeding Rectal bleeding Heme-positive stool Iron-deficiency anemia Systemic signs of infection Insomnia Moderate to severe depression/anxiety Moderate to severe panic attacks
\- Females that are pregnant, want to become pregnant for the duration of the study, or who are breastfeeding
What they're measuring
1
Reduction in IBS symptoms (bloating, heartburn and gas)