A Study Evaluating the Impact of Regular FODMAP-targeting Digestive Enzyme Blend Use on Gastrointestinal Symptoms in Individuals With Self-Reported Bloating
Kiwi Health Inc
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.
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 no…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
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 durin…
Interventions
- Dietary SupplementFODMAP-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.
- OtherPlacebo
An inactive substance that looks similar to the product being tested, however has no specific therapeutic effect to the condition being tested.
Location
- People ScienceLos Angeles, California