Actively Recruiting
A Study Evaluating the Impact of Regular FODMAP-targeting Digestive Enzyme Blend Use on Gastrointestinal Symptoms in Individuals With Self-Reported Bloating
Led by Kiwi Health Inc · Updated on 2026-05-15
150
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
K
Kiwi Health Inc
Lead Sponsor
P
People Science, Inc.
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Brief Title
A Study Evaluating the Impact of Regular FODMAP-targeting Digestive Enzyme Blend Use on Gastrointestinal Symptoms in Individuals With Self-Reported Bloating
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Individuals aged 18 years old or older
- Screening score of �3E= 55 on the PROMIS Scale v1.1 - Gastrointestinal Gas and Bloating 13a scale
- Screening severity score of �3E= 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; IBS participants must meet Rome IV criteria
- Able to maintain 80% compliance with daily questionnaires during 2 week run-in
- In good general health at screening
- Able to read, understand English, and provide informed consent
- Able to use a personal smartphone and download study app
- Able to receive shipment within the United States
- Able to complete study assessments for up to 19 weeks
You will not qualify if you...
- No personal smartphone, internet access, or unwilling to download study app
- Use of investigational therapies or treatments within 30 days prior to randomization
- Ongoing psychological therapies targeting GI symptoms or functional disorders
- Treatment with GLP-1 agonists within 90 days prior to randomization
- Current or recent chemotherapy or immunotherapy within last 6 months
- Current or planned use of other digestive enzymes
- Chronic use of medications causing substantial GI side effects within last 90 days
- Variable use of probiotics, fiber supplements, laxatives, stool softeners, or antidiarrheals in last 30 days
- Diagnosed Alcohol or Substance Use Disorder
- Currently pregnant, planning pregnancy within 4 months, or breastfeeding
- History of bariatric or significant GI surgery altering anatomy or function
- Conditions confounding symptom assessment (e.g., Type I diabetes, Endometriosis)
- Acute gastroenteritis within past 4 weeks
- Planned new diagnosis workup affecting participation
- Significant illness impacting ability to participate
- Known hypersensitivity or allergy to corn or digestive enzyme supplements
- Comorbid GI conditions like IBD, Microscopic Colitis, Celiac disease, or Bile Acid Malabsorption
- Screening score of �3E=10 on GAD-7 scale
- On or recently followed a low FODMAP diet
- History of failed low FODMAP diet
- Use or planned use of restrictive or weight-loss diets during study
- Planned changes in diet, lifestyle, or IBS medications during study
- Use of antibiotics, antifungals, or antivirals within 2 weeks prior to randomization
- Planned extended travel interfering with study
- Unlikely to comply with trial or deemed unsuitable by Principal Investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote) for eligibility assessment
Duration - 2 weeks
Participants complete a 2-week run-in period to establish baseline symptom and compliance with daily questionnaires.
Daily self-report questionnaires using a study app
Duration - 10 weeks (4 weeks treatment, 2 weeks washout, 4 weeks treatment)
Participants take either the FODMAP-targeting digestive enzyme blend or placebo with each meal, snack, or substantial beverage for 4 weeks, followed by a 2-week washout, then switch to the alternate product for another 4 weeks.
Daily product use and symptom reporting via study app
Duration - Up to 3 weeks after last treatment
Participants complete final assessments of gastrointestinal symptoms after completing both treatment periods.
Final symptom questionnaires via study app
Trial Site Locations
Total: 1 location
1
People Science
Los Angeles, California, United States, 90045
Actively Recruiting
Research Team
M
Megha Doshi, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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