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

NCT07591584 | Recruiting

• 1 other identifier: PS37
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

IBS (Irritable Bowel Syndrome); Bloating; Abdominal Pain; Gut Health

Keywords

bloating; gas; abdominal pain; IBS

Outcome Measures

Primary Outcomes (1)

• Bloating Symptoms

  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).

  19 weeks

Secondary Outcomes (2)

• Gastrointestinal Symptoms

  19 weeks

• Abdominal Pain

  19 weeks

Study Arms (2)

Arm A

ACTIVE COMPARATOR

Half the participants will start on Arm A. They will use product from Arm A for the first for 4 weeks. Then there will be a two week washout and then the participant will use product from Arm B for the next four weeks.

Dietary Supplement: FODMAP-targeting digestive enzyme blend

Arm B

PLACEBO COMPARATOR

Half the participants will start on Arm B. They will use product from Arm B for the first for 4 weeks. Then there will be a two week washout and then the participant will use product from Arm A for the next four weeks.

Other: Placebo

Interventions

FODMAP-targeting digestive enzyme blend DIETARY_SUPPLEMENT

Targeted Action: It is a novel enzyme blend designed to break down specific Fermentable Oligosaccharides, Disaccharides, Monosaccharides, and Polyols (FODMAPs)-fructan, Galacto-oligosaccharides (GOS), and lactose-before they ferment in the colon. Administration: It must be taken with each meal, snack, or substantial beverage and applied directly to the food. Study Population: It targets adults with self-reported bloating, including those with Irritable Bowel Syndrome (IBS-C, IBS-D, IBS-M) and non-IBS populations.1 Safety/Exclusion: Participants with a known hypersensitivity to corn or prior reactions to other digestive enzyme supplements (e.g., Beano and Lactaid) are specifically excluded to mitigate risk. Regulatory Status: It is evaluated as a consumer-grade supplement in decentralized research and is explicitly not intended to support FDA-regulated drug applications or provide medical management.

Arm A

Placebo OTHER

An inactive substance that looks similar to the product being tested, however has no specific therapeutic effect to the condition being tested.

Arm B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kiwi Health Inc: lead
• People Science, Inc.: collaborator

Study Sites (1)

People Science

Los Angeles, California, 90045, United States

RECRUITING

MeSH Terms

Conditions

Irritable Bowel Syndrome; Abdominal Pain; Mucopolysaccharidosis IV

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Mucopolysaccharidoses; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lysosomal Storage Diseases; Mucinoses; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Ashley Mateus, Ph.D.

  People Science

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Megha Doshi, MD

CONTACT

213 3280919; megha@peoplescience.health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 15, 2026
• Study Start: May 4, 2026
• Primary Completion (Estimated): October 26, 2026
• Study Completion (Estimated): October 26, 2026
• Last Updated: May 15, 2026

Record last verified: 2026-05

Locations

US (1)