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

Last updated: May 11, 2026
Sponsor: Kiwi Health Inc
Overall Status: Active - Recruiting

Phase

N/A

Condition

Colic

Ulcerative Colitis (Pediatric)

Lactose Intolerance

Treatment

FODMAP-targeting digestive enzyme blend

Placebo

Clinical Study ID

NCT07591584
PS37
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This study is a randomized, double-blind, placebo-controlled, within-individual crossover trial designed to assess the impact of regular use of a consumer-grade FODMAP-targeting digestive enzyme blend (FODZYME®) on gastrointestinal symptoms in adults with self-reported bloating.1

The study's rationale is based on the fact that fermentable carbohydrates (FODMAPs) are often poorly absorbed and can trigger symptoms like bloating and abdominal pain. While a Low FODMAP Diet (LFD) is clinically validated for symptom relief, it is restrictive. The enzyme blend is intended to offer a more flexible, enzyme-based solution by targeting and breaking down FODMAPs, such as fructan, GOS, and lactose, before they ferment in the colon.

The primary objective is to evaluate the product's impact on bloating symptoms, measured by the mean PROMIS scale Gastrointestinal Gas and Bloating score. Secondary and exploratory objectives include assessing the impact on overall gastrointestinal symptom severity (IBS-SSS), abdominal pain (PROMIS Belly Pain score), food-related quality of life (FR-QoL-29), and anxiety (GAD-7 scores). The study also aims to evaluate these effects across various Irritable Bowel Syndrome (IBS) subgroups (IBS-C, IBS-D, IBS-M). The trial is a consumer-driven, decentralized research study utilizing validated patient-reported outcome measures that can be completed in a home setting.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Individuals aged 18 years old or older

  • Screening score of >= 55 on the PROMIS Scale v1.1 - Gastrointestinal Gas andBloating 13a scale.

  • Screening severity score of >= 55 on the PROMIS Scale v1.0 - Gastrointestinal BellyPain 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 symptomsmust 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-inperiod.

  • 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

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 orfunctional disorders, including but not limited to GI-directed Cognitive BehavioralTherapy (CBT), GI hypnotherapy, or other therapies for Disorders of Gut-BrainInteraction (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 knowneffects on gut motility and GI symptoms.

  • Current or recent (within the last 6 months) chemotherapy or immunotherapy forcancer treatment.

  • Current or planned use of any other digestive enzymes prescription orover-the-counter (OTC).

  • Chronic use (defined as daily use for >30 days within the last 90 days) of anymedication known to have substantial gastrointestinal side effects (e.g., diarrhea,constipation, nausea) that, in the opinion of the Principal Investigator, mayconfound 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 ofany probiotic, fiber supplement, laxative, stool softener, or antidiarrheal with adose change greater than 50% in the last 30 days or initiation or discontinuation ofa 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, orbreastfeeding

  • History of bariatric or other significant gastrointestinal surgery (e.g., smallbowel resection, total colectomy) that has permanently altered GI anatomy orfunction. 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 thatcould affect eligibility).

  • Have a significant illness, disease or condition which, in the opinion of theprincipal investigator, may impact their ability to participate in the study orimpact the study outcomes.

  • Self-reported known hypersensitivity or previous allergic reaction to cornand/or any previous reaction to digestive enzyme supplements (eg. Beano andLactaid)

  • Comorbid GI conditions: IBD - Ulcerative Colitis or Crohn's Disease,Microscopic Colitis, history of small bowel or colonic surgeries, Celiacdisease, 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. failedLFD in past)

  • Participants who are on or plan to initiate a major restrictive or eliminationdiet, or a structured weight-loss diet, during the study period.

  • No planned changes in diet, lifestyle or medications for IBS during studyperiod.

  • Use of any antibiotics, antifungals, or antivirals within 2 weeks prior torandomization.

  • Participants planning extended travel that would interfere with compliance orstudy procedures.

  • Are unlikely for any reason to be able to comply with the trial or consideredunsuited for participation in the study by the Principal Investigator.

Study Design

Total Participants: 150
Treatment Group(s): 2
Primary Treatment: FODMAP-targeting digestive enzyme blend
Phase:
Study Start date:
May 04, 2026
Estimated Completion Date:
October 26, 2026

Study Description

The study product is a FODMAP-targeting digestive enzyme blend designed as a novel, consumer-grade digestive enzyme supplement. Its primary function is to target and break down fermentable short-chain carbohydrates (FODMAPs) in the gut, specifically fructan, Galacto-oligosaccharides (GOS), and lactose, before they can be fermented in the colon.

The product offers an enzyme-based approach to managing symptoms, such as bloating and abdominal pain, which are often triggered by FODMAPs in individuals with Irritable Bowel Syndrome (IBS), Functional Dyspepsia (FD), endometriosis, and the broader non-IBS population. This is intended as a more flexible alternative to a Low FODMAP Diet (LFD), which is clinically proven for symptom relief but can be restrictive and difficult to maintain long-term.

Key Characteristics and Use:

Administration: The study product/placebo is to be taken with each meal, snack, or substantial beverage and is applied directly to the food.

Safety and Risk Mitigation: As a digestive enzyme supplement, potential minor risks include temporary gastrointestinal side effects like GI upset, increased gas, or mild changes in bowel habits. To mitigate the risk of allergic reaction, participants with a self-reported known hypersensitivity to corn or previous reactions to digestive enzyme supplements (e.g., Beano and Lactaid) are excluded from the study.

Regulatory Context: This product is a consumer-grade supplement being evaluated in a research study and is not intended to diagnose, prevent, cure, or mitigate specific medical diseases, nor is the research intended to support FDA-regulated drug applications.

Connect with a study center

  • People Science

    Los Angeles, California 90045
    United States

    Active - Recruiting

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