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.
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
Do not have a personal smartphone, internet access, or unwilling to download Chloe.
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.
Crossover
FODMAP-targeting digestive enzyme blend
Dietary supplementTargeted 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.
Placebo
Other interventionAn inactive substance that looks similar to the product being tested, however has no specific therapeutic effect to the condition being tested.
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).
Gastrointestinal Symptoms
The Secondary outcome measure will be used to evaluate impact of FODMAP-targeting digestive enzyme blend use on gastrointestinal symptom severity. This will be done by using the Mean IBS-SSS score between study product and placebo groups at the end of each study product use period. Scale title: Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS) Minimum/maximum values: 0-500 Interpretation: Higher scores indicate worse IBS symptom severity. Scores \<175 are generally considered mild, 175-300 moderate, and \>300 severe IBS symptoms.
Abdominal Pain
The secondary outcome measure will be used to evaluate the impact of FODMAP-targeting digestive enzyme blend use on overall abdominal pain. This will be measured using the Mean PROMIS scale Belly Pain 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 - Belly Pain 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 6-30 (6 items). Interpretation: Higher scores indicate worse abdominal pain symptoms.
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Kiwi Health Inc
Lead sponsor
People Science, Inc.
Collaborator
