Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Regular enzyme blend to help bloating in adults with IBS and similar symptoms

Official title: A Study Evaluating the Impact of Regular FODMAP-targeting Digestive Enzyme Blend Use on Gastrointestinal Symptoms in Individuals With Self-Reported Bloating

Run by Kiwi Health Inc · NCT07591584 · Data updated 2026-11-12

This study tests whether a FODMAP-targeting digestive enzyme blend (taken with meals) reduces bloating and related gut symptoms compared with placebo in adults who self-report bloating.

More Abdominal Pain trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment150 (estimated)
SponsorKiwi Health Inc
Industry-sponsored
Drugs / interventionschemotherapy, immunotherapy
Locations1 site (Los Angeles, California)
StatusRecruiting
StartedMay 4, 2026
Main results expectedOctober 26, 2026
Study endsOctober 26, 2026
Registry record updatedMay 15, 2026
Trial IDNCT07591584 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults 18 and older with self-reported bloating, and with or without IBS, who meet specific symptom and health criteria and can comply with study procedures.

Probably not a fit

Some participants may not experience noticeable symptom relief from the enzyme blend.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, placebo-controlled, within-subject crossover trial evaluating a consumer-grade digestive enzyme blend designed to break down FODMAPs before they reach the colon. Participants take the product or placebo with meals during periods separated by a washout, allowing each person to serve as their own control. Primary outcome is change in bloating measured by PROMIS Gastrointestinal Gas and Bloating scores; secondary outcomes include overall gastrointestinal symptom severity. The study aims to offer a flexible alternative to a strict low-FODMAP diet for managing IBS-related symptoms.

Why it matters

Potential benefit: If successful, participants could experience reduced bloating and abdominal discomfort with a convenient, enzyme-based approach.

How similar studies have gone: Prior approaches targeting FODMAPs with diet have shown symptom relief; this enzyme-based approach is a novel, translational method with some precedent in symptom management.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Individuals aged 18 years old or older
* Screening score of \>= 55 on the PROMIS Scale v1.1 - Gastrointestinal Gas and Bloating 13a scale.
* Screening severity score of \>= 55 on the PROMIS Scale v1.0 - Gastrointestinal Belly Pain scale.
* Screening score of \<10 on the Generalized Anxiety Disorder 7-item (GAD-7) scale
* Adults with or without IBS are eligible; participants with IBS experiencing symptoms must meet the Rome IV criteria as determined by the Rome IV Diagnostic Questionnaire (R4DQ) IBS Module.
* Able to maintain 80% compliance with daily questionnaires during the 2 week run-in period.
* In good general health at the time of screening (Investigator discretion).
* Able to read and understand English and provide informed consent.
* Able to use a personal smartphone device and download Chloe by People Science.
* Able to receive shipment of the product at an address within the United States.
* Able to complete study assessments over the course of up to 19 weeks.

Exclusion Criteria:

* Do not have a personal smartphone, internet access, or unwilling to download Chloe.
* Concomitant Therapies:

Participants receiving any of the following treatments or therapies are excluded:

* Any investigational therapies or treatments (pharmaceuticals, devices, supplements) within 30 days prior to randomization.
* Ongoing psychological therapies specifically targeting gastrointestinal symptoms or functional disorders, including but not limited to GI-directed Cognitive Behavioral Therapy (CBT), GI hypnotherapy, or other therapies for Disorders of Gut-Brain Interaction (DGBI).
* Treatment with Glucagon-like peptide-1 (GLP-1) agonists (e.g., semaglutide, tirzepatide) within the last 90 days prior to randomization, due to their known effects on gut motility and GI symptoms.
* Current or recent (within the last 6 months) chemotherapy or immunotherapy for cancer treatment.
* Current or planned use of any other digestive enzymes prescription or over-the-counter (OTC).
* Chronic use (defined as daily use for \>30 days within the last 90 days) of any medication known to have substantial gastrointestinal side effects (e.g., diarrhea, constipation, nausea) that, in the opinion of the Principal Investigator, may confound the assessment of study outcomes. This may include high-dose NSAIDs, opioids, prokinetics, bile acid binders, or certain antibiotics.
* Variable use of probiotics, fiber supplements, laxatives, stool softeners, antidiarrheals (if taking) in the last 30 days. Variable use is defined as use of any probiotic, fiber supplement, laxative, stool softener, or antidiarrheal with a dose change greater than 50% in the last 30 days or initiation or discontinuation of a gut-active product in the last 30 days.

  * Other Illnesses or Conditions:

Participants who have the following comorbidities or gastrointestinal illnesses are excluded:

* Currently diagnosed with Alcohol Use Disorder and/or Substance Use Disorder
* Currently pregnant, planning to become pregnant in the next 4 months, or breastfeeding
* History of bariatric or other significant gastrointestinal surgery (e.g., small bowel resection, total colectomy) that has permanently altered GI anatomy or function. Standard appendectomy or cholecystectomy are generally permitted.

Any underlying medical conditions or comorbidities that may confound the assessment of digestive symptoms or the evaluation of the study outcomes (e.g., Type I diabetes, Endometriosis, etc.).

* Acute gastroenteritis within the past 4 weeks;
* New diagnosis workup planned during study that may change diagnosis/ behavior/ medications (eg. colonoscopy prep or major bowel cleanse, upcoming GI consult that could affect eligibility).
* Have a significant illness, disease or condition which, in the opinion of the principal investigator, may impact their ability to participate in the study or impact the study outcomes.

  * Self-reported known hypersensitivity or previous allergic reaction to corn and/or any previous reaction to digestive enzyme supplements (eg. Beano and Lactaid)
  * Comorbid GI conditions: IBD - Ulcerative Colitis or Crohn's Disease, Microscopic Colitis, history of small bowel or colonic surgeries, Celiac disease, or Bile Acid Malabsorption (BAM).
  * Screening score of ≥10 on the Generalized Anxiety Disorder 7-item (GAD-7) scale
  * On a low FODMAP diet based on FODMAP FFQ results at Screening
  * History of following a low FODMAP diet in the past 6 months (self-reported)
  * Any history of following LFD (Low FODMAP Diet) with no response (i.e. failed LFD in past)
  * Participants who are on or plan to initiate a major restrictive or elimination diet, or a structured weight-loss diet, during the study period.
  * No planned changes in diet, lifestyle or medications for IBS during study period.
  * Use of any antibiotics, antifungals, or antivirals within 2 weeks prior to randomization.
  * Participants planning extended travel that would interfere with compliance or study procedures.
  * Are unlikely for any reason to be able to comply with the trial or considered unsuited for participation in the study by the Principal Investigator.

Where it's running

  • People Science
    Los Angeles, California, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.