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Completed

NCT Number: NCT05197413

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

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).

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Key information

Conditions

IBS - Irritable Bowel Syndrome Anxiety Anxiety Disorders Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Irritable Bowel Syndrome Mental Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Citruslabs

Santa Monica, California, 90404, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Arrae

Industry

Collaborators

  • Citruslabs

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 19, 2022
Registry last updated
Jan 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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