Clinical trial 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
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
Overall status: COMPLETED
Phase: NA
Conditions: IBS - Irritable Bowel Syndrome
Anxiety
Lead sponsor: Arrae
Sponsor class: INDUSTRY
Collaborators: name: Citruslabs
First posted: 2022-01-19
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Reduction in IBS symptoms (bloating, heartburn and gas)
timeFrame: 4 weeks
measure: Reduction in anxiety symptoms
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Citruslabs
state: California
Study officials:
References: