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

• ClinicalTrials.gov Identifier: NCT05197413
• Recruitment Status: Completed
• First Posted: January 19, 2022
• Last Update Posted: January 19, 2022
• Sponsor: Arrae
• Collaborator: Citruslabs
• Information provided by (Responsible Party): Arrae

Study Description

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).

Condition or disease	Intervention/treatment	Phase
IBS - Irritable Bowel Syndrome; Anxiety	Dietary Supplement: Arrae bloat supplement	Not Applicable

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 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 35 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: September 1, 2021
• Actual Primary Completion Date: December 31, 2021
• Actual Study Completion Date: December 31, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Arrae Bloat supplement; 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; 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.

Outcome Measures

Primary Outcome Measures :

1. Reduction in IBS symptoms (bloating, heartburn and gas) [ Time Frame: 4 weeks ]
   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.
2. Reduction in anxiety symptoms [ Time Frame: 8 weeks ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United States, California

Citruslabs

Santa Monica, California, United States, 90404

Sponsors and Collaborators

Arrae

Citruslabs

More Information

• Responsible Party: Arrae
• ClinicalTrials.gov Identifier: NCT05197413
• Other Study ID Numbers: 20219Arrae
• First Posted: January 19, 2022
• Last Update Posted: January 19, 2022
• Last Verified: January 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Irritable Bowel Syndrome; Heartburn; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive