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

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

Interventions

DIETARY_SUPPLEMENT

FODMAP-targeting digestive enzyme blend

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.

OTHER

Placebo

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

Sponsors & Collaborators

• People Science, Inc.

  collaborator INDUSTRY

• Kiwi Health Inc

  lead INDUSTRY

Principal Investigators

• Ashley Mateus, Ph.D. · People Science

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-05-04

Primary Completion

2026-10-26

Completion

2026-10-26

Countries

• United States

Study Locations