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

NCT05197413 | Completed

• 1 other identifier: 20219Arrae
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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 symptoms).

Conditions

IBS - Irritable Bowel Syndrome; Anxiety

Outcome Measures

Primary Outcomes (2)

• Reduction in IBS symptoms (bloating, heartburn and gas)

  Survey-based assessment (0-5 scale with 0 being the lowest possible score and 5 being the highest) of changes in IBS symptoms between baseline and study intervention period.

  4 weeks

• Reduction in anxiety symptoms

  Survey-based assessment (0-5 scale with 0 being the lowest possible score and 5 being the highest) of changes in anxiety symptoms between baseline and study intervention period.

  8 weeks

Study Arms (1)

Arrae Bloat supplement

EXPERIMENTAL

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

Dietary Supplement: Arrae bloat supplement

Interventions

Arrae bloat supplement DIETARY_SUPPLEMENT

The supplement contains organic dandelion root extract, organic lemon balm herb top extract, organic peppermint leaf extract, organic bromelain, organic slippery elm inner bark extract. The capsule itself is made of cellulose, which is not a main active ingredient.

Arrae Bloat supplement

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Arrae: lead
• Citruslabs: collaborator

Study Sites (1)

Citruslabs

Santa Monica, California, 90404, United States

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome; Anxiety Disorders

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2022
• First Posted: January 19, 2022
• Study Start: September 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: January 19, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)