NCT07591584 A Study Evaluating the Impact of Regular FODMAP-targeting Digestive Enzyme Blend Use on Gastrointestinal Symptoms in Individuals With Self-Reported Bloating
| NCT ID | NCT07591584 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Kiwi Health Inc |
| Condition | IBS (Irritable Bowel Syndrome) |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2026-05-04 |
| Primary Completion | 2026-10-26 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2026-05-04 with a primary completion date of 2026-10-26.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 * Adults with or without IBS are eligible; participants with IBS experiencing symptoms must meet the Rome IV criteria as determined by the Rome IV Diagnostic Questionnaire (R4DQ) IBS Module. * Able to maintain 80% compliance with daily questionnaires during the 2 week run-in period. * In good general health at the time of screening (Investigator discretion). * Able to read and understand English and provide informed consent. * Able to use a personal smartphone device and download Chloe by People Science. * Able to receive shipment of the product at an address within the United States. * Able to complete study assessments over the course of up to 19 weeks. Exclusion Criteria: * Do not have a personal smartphone, internet access, or unwilling to download Chloe. * Concomitant Therapies: Participants receiving any of the following treatments or therapies are excluded: * 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. * Current or recent (within the last 6 months) chemotherapy or immunotherapy for cancer treatment. * Current or planned use of any other digestive enzymes prescription or over-the-counter (OTC). * Chronic use (defined as daily use for \>30 days within the last 90 days) of any medication known to have substantial gastrointestinal side effects (e.g., diarrhea, constipation, nausea) that, in the opinion of the Principal Investigator, may confound the assessment of study outcomes. This may include high-dose NSAIDs, opioids, prokinetics, bile acid binders, or certain antibiotics. * Variable use of probiotics, fiber supplements, laxatives, stool softeners, antidiarrheals (if taking) in the last 30 days. Variable use is defined as use of any probiotic, fiber supplement, laxative, stool softener, or antidiarrheal with a dose change greater than 50% in the last 30 days or initiation or discontinuation of a gut-active product in the last 30 days. * Other Illnesses or Conditions: Participants who have the following comorbidities or gastrointestinal illnesses are excluded: * Currently diagnosed with Alcohol Use Disorder and/or Substance Use Disorder * Currently pregnant, planning to become pregnant in the next 4 months, or breastfeeding * History of bariatric or other significant gastrointestinal surgery (e.g., small bowel resection, total colectomy) that has permanently altered GI anatomy or function. Standard appendectomy or cholecystectomy are generally permitted. Any underlying medical conditions or comorbidities that may confound the assessment of digestive symptoms or the evaluation of the study outcomes (e.g., Type I diabetes, Endometriosis, etc.). * Acute gastroenteritis within the past 4 weeks; * New diagnosis workup planned during study that may change diagnosis/ behavior/ medications (eg. colonoscopy prep or major bowel cleanse, upcoming GI consult that could affect eligibility). * Have a significant illness, disease or condition which, in the opinion of the principal investigator, may impact their ability to participate in the study or impact the study outcomes. * Self-reported known hypersensitivity or previous allergic reaction to corn and/or any previous reaction to digestive enzyme supplements (eg. Beano and Lactaid) * Comorbid GI conditions: IBD - Ulcerative Colitis or Crohn's Disease, Microscopic Colitis, history of small bowel or colonic surgeries, Celiac disease, or Bile Acid Malabsorption (BAM). * Screening score of ≥10 on the Generalized Anxiety Disorder 7-item (GAD-7) scale * On a low FODMAP diet based on FODMAP FFQ results at Screening * History of following a low FODMAP diet in the past 6 months (self-reported) * Any history of following LFD (Low FODMAP Diet) with no response (i.e. failed LFD in past) * Participants who are on or plan to initiate a major restrictive or elimination diet, or a structured weight-loss diet, during the study period. * No planned changes in diet, lifestyle or medications for IBS during study period. * Use of any antibiotics, antifungals, or antivirals within 2 weeks prior to randomization. * Participants planning extended travel that would interfere with compliance or study procedures. * Are unlikely for any reason to be able to comply with the trial or considered unsuited for participation in the study by the Principal Investigator.
Contact & Investigator
Ashley Mateus, Ph.D.
PRINCIPAL INVESTIGATOR
People Science
Frequently Asked Questions
Who can join the NCT07591584 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying IBS (Irritable Bowel Syndrome). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07591584 currently recruiting?
Yes, NCT07591584 is actively recruiting participants. Contact the research team at megha@peoplescience.health for enrollment information.
Where is the NCT07591584 trial being conducted?
This trial is being conducted at Los Angeles, United States.
Who is sponsoring the NCT07591584 clinical trial?
NCT07591584 is sponsored by Kiwi Health Inc. The principal investigator is Ashley Mateus, Ph.D. at People Science. The trial plans to enroll 150 participants.