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

Last updated: January 5, 2022
Sponsor: Arrae
Overall Status: Completed

Phase

N/A

Condition

Heartburn

Colic

Lactose Intolerance

Treatment

N/A

Clinical Study ID

NCT05197413
20219Arrae
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Female over 18 years old
  • Self-reported (undiagnosed) IBS symptoms, such as self-reported abdominal pain, gasproduction and bloating after meals, heartburn after meals
  • Must be in good health (don't report any medical conditions asked in the screeningquestionnaire)
  • Following a stable, consistent diet regimen
  • Agree to refrain from any lifestyle changes that may affect their GI tract and IBSsymptoms 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

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 bleedingHeme-positive stool Iron-deficiency anemia Systemic signs of infection Insomnia Moderate tosevere depression/anxiety Moderate to severe panic attacks

  • Females that are pregnant, want to become pregnant for the duration of the study, or whoare breastfeeding

Study Design

Total Participants: 35
Study Start date:
September 01, 2021
Estimated Completion Date:
December 31, 2021

Study 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.

Connect with a study center

  • Citruslabs

    Santa Monica, California 90404
    United States

    Site Not Available

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