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A Study on FODMAP-targeting Digestive Enzymes for Bloating

This study is looking at how a digestive enzyme blend called FODMAP-targeting digestive enzyme blend affects bloating and other gut symptoms. This blend is designed to break down specific sugars (FODMAPs like fructan, GOS, and lactose) before they cause problems in your gut. You might be able to join if you are 18 or older and experience bloating or belly pain, even if you don't have Irritable Bowel Syndrome (IBS). The study will measure changes in your bloating symptoms over 19 weeks. The current status of this study is unclear, and it plans to enroll 150 people.

Study design
This is a randomized, double-blind, placebo-controlled study, meaning participants will be randomly assigned to receive either the active enzyme blend or an inactive substance (placebo) without knowing which they are getting. The study will involve 150 participants.
What's involved
The study product or placebo is to be taken with each meal, snack, or substantial beverage and applied directly to the food.
Compensation
Not stated in the trial record.
Follow-up
Your bloating symptoms will be measured at 19 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07591584

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

Recruiting
NAAges 18+InterventionalSupportive care
Kiwi Health Inc
~150 participants
Updated 2026-05-15 on ClinicalTrials.gov
What's tested:FODMAP-targeting digestive enzyme blendPlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Bloating Symptoms
Measured over 19 weeks

Conditions

IBS (Irritable Bowel Syndrome)
Bloating
Abdominal Pain
Gut Health

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Abdominal PainBloatingIrritable Bowel Syndrome

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Ashley Mateus, Ph.D. · PRINCIPAL_INVESTIGATOR · People Science, Inc.

Who to contact

Megha Doshi, MD
[email protected]
213 3280919
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Bloating Symptoms19 weeks

    The Primary outcome will be to evaluate the impact of FODMAP-targeting digestive enzyme blend use on bloating symptoms. This will be done by using the Mean PROMIS scale Gastrointestinal Gas and Bloating score between study product and placebo groups at the end of each study product use period. Scale title: Patient-Reported Outcomes Measurement Information System (PROMIS) Gastrointestinal Symptoms Scale - Gas and Bloating Scoring: Typically reported as a standardized T-score (reference population mean = 50, SD = 10). Minimum/maximum values: T-scores do not have fixed absolute minimum or maximum values, though scores commonly range approximately from 20-80 in practice. The raw summed score range is 11-55 (11 scored items). Interpretation: Higher scores indicate worse gastrointestinal symptoms (more gas/bloating severity).