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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

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

Study Details

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.

Key Dates

Start date

May 4, 2026

Status verified

May 2026

Primary completion

Oct 26, 2026

Completion

Oct 26, 2026

Study Design

Enrollment

150 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

SUPPORTIVE_CARE

Arms

• Active Comparator: Arm A
  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.
• Placebo Comparator: Arm B
  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.

Primary Outcome Measure

Bloating Symptoms [ Time Frame: 19 weeks ]

Central Contacts

• Megha Doshi, MD
  213 3280919
  [email protected]

Locations (1)

Find similar trials in Los Angeles, CA

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