New enzyme blend could be the key to beating bloating
NCT ID NCT07591584
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a daily enzyme supplement (FODZYME®) can reduce bloating and stomach pain in adults who often feel bloated. About 150 people will take either the enzyme or a placebo for a period, then switch, to see if the enzyme helps break down hard-to-digest carbs. The goal is to offer a simpler alternative to the restrictive low-FODMAP diet.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 150 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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People Science
RECRUITINGLos Angeles, California, 90045, United States
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Other studies related to the condition(s) this trial covers.
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