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

Arrae

Status: Completed

Conditions: IBS - Irritable Bowel Syndrome; Anxiety

Treatments: Dietary Supplement: Arrae bloat supplement

Study type: Interventional

Funder types: Industry

Identifiers

NCT05197413

20219Arrae

Details and patient eligibility

About

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).

Full 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 as "Arrae Calm" will support the effects of "Arrae Bloat", while reducing stress, anxiety and panic and promoting restful sleep and easing tension in the body, which has previously been reported in customer feedback studies.

Enrollment: 35 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Arrae Bloat supplement

Experimental group

Description:

The "Bloat" capsules are a blend of 5 herbs and a fruit-based digestive enzyme that target the cause for IBS symptoms.

Treatment:

Dietary Supplement: Arrae bloat supplement