Digestive Enzyme Blend for Abdominal Bloating
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Ashley Mateus, Ph.D.
Principal Investigator
People Science
Are You a Good Fit for This Trial?
This trial is for adults who often experience bloating and other gut symptoms, such as those with irritable bowel syndrome (IBS). Participants must self-report regular bloating. People with certain rare conditions or other exclusions may not be eligible.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either the active FODMAP-targeting digestive enzyme blend or placebo for 4 weeks, followed by a 2-week washout period, and then crossover to the alternate treatment for another 4 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- FODMAP-targeting digestive enzyme blend
Trial Overview
The study compares a FODMAP-targeting digestive enzyme blend (FODZYME®) to a placebo. Each participant tries both treatments in random order at home, to see if the enzyme helps reduce bloating and related gut symptoms.
How Is the Trial Designed?
2
Treatment groups
Active Control
Placebo Group
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Kiwi Health Inc
Lead Sponsor
People Science, Inc.
Industry Sponsor
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