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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

Primary Purpose

IBS - Irritable Bowel Syndrome, Anxiety

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Arrae bloat supplement

About this trial

This is an interventional treatment trial for IBS - Irritable Bowel Syndrome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

Citruslabs

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arrae Bloat supplement

Arm Description

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

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT05197413

First Posted

January 5, 2022

Last Updated

January 5, 2022

Sponsor

Arrae

Collaborators

Citruslabs

1. Study Identification

Unique Protocol Identification Number

NCT05197413

Brief 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

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Completed

Study Start Date

September 1, 2021 (Actual)

Primary Completion Date

December 31, 2021 (Actual)

Study Completion Date

December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Arrae

Collaborators

Citruslabs

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

IBS - Irritable Bowel Syndrome, Anxiety

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

35 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arrae Bloat supplement

Arm Type

Experimental

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Arrae bloat supplement

Intervention Description

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.

Primary Outcome Measure Information:

Title

Reduction in IBS symptoms (bloating, heartburn and gas)

Description

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.

Time Frame

4 weeks

Title

Reduction in anxiety symptoms

Description

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.

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Citruslabs

City

Santa Monica

State/Province

California

ZIP/Postal Code

90404

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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