Status:
COMPLETED
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
Lead Sponsor:
Arrae
Collaborating Sponsors:
Citruslabs
Conditions:
IBS - Irritable Bowel Syndrome
Anxiety
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 sympt...
Detailed Description
It is hypothesized that the dietary supplement marketed as "Arrae Bloat" will improve subjective wellbeing in trial participants. It is further hypothesized that a second dietary supplement marketed a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT05197413
Start Date
September 1 2021
End Date
December 31 2021
Last Update
January 19 2022
Active Locations (1)
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1
Citruslabs
Santa Monica, California, United States, 90404