Evaluating the Effects of a Digestive Enzyme Blend Targeting FODMAPs on Gastrointestinal Symptoms Including Bloating in Adults with Self-Reported Bloating

What this Trial Is About

Researchers are evaluating the impact of regular use of a consumer-grade FODMAP-targeting digestive enzyme blend called FODZYME on gastrointestinal symptoms in adults who experience self-reported bloating. The study focuses on how this enzyme blend affects symptoms such as bloating and abdominal pain, which are often triggered by fermentable carbohydrates known as FODMAPs. This is a randomized, double-blind, placebo-controlled crossover trial that aims to provide a more flexible alternative to the restrictive Low FODMAP Diet by breaking down FODMAPs before they ferment in the colon. Participants will take the enzyme blend or a placebo with each meal, snack, or substantial beverage, applying it directly to their food. The trial is divided into two main periods half the participants will start with the enzyme blend for four weeks followed by a two-week washout and then switch to placebo for another four weeks the other half start with placebo and then switch to the enzyme blend after the washout. The study product is designed to target specific FODMAPs like fructan, GOS, and lactose and is intended for adults with or without IBS symptoms. During the study, participants will complete daily questionnaires and assessments over about 19 weeks, including patient-reported outcome measures for bloating, gastrointestinal symptoms, abdominal pain, food-related quality of life, and anxiety. The study is conducted remotely, allowing participants to complete assessments at home using a smartphone app. Safety is monitored by excluding those with known allergies to corn or previous reactions to digestive enzyme supplements, and researchers will review changes in bloating symptoms as the primary outcome.

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