An interventional study of Arrae bloat supplement in IBS - Irritable Bowel Syndrome and Anxiety, sponsored by Arrae. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-19.
Sponsored by Arrae · Not applicable, Interventional, and Treatment
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Among 344 studies in Irritable Bowel Syndrome with a site in United States — 45 open to participants now, 49 under way, 3 of them phase 3. Irritable Bowel Syndrome · United States.
Among the 344 studies in Irritable Bowel Syndrome with a site in United States, this one is the 200th largest by enrollment of the 287 interventional ones that give a count, is one of 13 that started in 2021, is one of 134 with no phase, and was the 271st registered.
1,116 studies on the registry are indexed under Irritable Bowel Syndrome; 208 are open to participants now.
Browse Irritable Bowel Syndrome studies →45 of the 344 studies in Irritable Bowel Syndrome with a site in United States are open now. Recruiting first, the newest first:
Baylor College of Medicine · Sites in United States
Ages 7–12
University of Michigan · Sites in United States
Ages 18–65
Eli Lilly and Company · Sites in United States, Belgium, Canada and 7 more countries
Ages 18–75
Kiwi Health Inc · Sites in United States
Ages 18+ · Healthy volunteers
Eli Lilly and Company · Sites in United States, Belgium, Canada and 5 more countries
Ages 18–75
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 126 Irritable Bowel Syndrome studies recruiting now, 33 (26%) set no upper age limit and 83 (66%) stop at 75 or younger; 18 take children under 18; 28 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
344 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 22 · Phase 2 91 · Phase 3 38 · Phase 4 15
First in 1996; this study’s year is marked. 13 started in 2021.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 35 is below the median of 70 across 896 interventional studies indexed under Irritable Bowel Syndrome.
Median enrollment 61 across the 287 interventional studies, 150 across the 55 observational. Of the 274 that completed or were terminated, 104 (38%) have results posted.
This tab as a report to print or save as PDF → With an account.
119 of 344 have an industry lead sponsor. The 10 most frequent:
Arrae is the lead sponsor of 4 studies on the registry; 3 are open to participants now.
Arrae has 1 study filed under Irritable Bowel Syndrome — fewer than ten, so there is no comparison to draw.
24 of the studies in Irritable Bowel Syndrome with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05519683Phase 3University of MichiganHome Transcutaneous Electrical Acustimulation (TEA) | 2027-03 |
| NCT04506593Indiana UniversityIndiana University Gastrointestinal Motility Diagnosis Registry | 2026-11 |
| NCT06760533NYU Langone HealthPsilocybin-Assisted Psychotherapy in Treating Irritable Bowel Syndrome (IBS) | 2026-12 |
| NCT06288672IBS-80, LLCIBS Skin Patch Test Food Allergy Study | 2026-12 |
| NCT06684470Mayo ClinicNovel Pilot Study to Treat Symptoms of IBS With Diarrhea Using Combination Therapy of a Low-FODMAP Diet and a Neuromodulator | 2026-12-19 |
Add all 24 to your calendar (.ics) → With an account.
Among the 344 studies in Irritable Bowel Syndrome with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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).
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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.
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.
Time frame: 4 weeks
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.
Time frame: 8 weeks
Plan to share: No
No publications or documents are linked to this record.
Ran from Sep 2021 to primary completion in Dec 2021, 3 months.
Of 52 industry-sponsored interventional studies with no phase under Irritable Bowel Syndrome, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 28. This study's 3 months is below that.
Counting every sponsor, half of 357 studies reached it within 19 months; a quarter within 9 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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