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New treatment option for IBS (Irritable Bowel Syndrome)
Official title A Study Evaluating the Impact of Regular FODMAP-targeting Digestive Enzyme Blend Use on Gastrointestinal Symptoms in Individuals With Self-Reported Bloating
ClinicalTrials.gov ID: NCT07591584
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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...
You likely can't join if
- 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...
- Treatment with Glucagon-like peptide-1 (GLP-1) agonists (e.g., semaglutide, tirzepatide) within the last 90 days prior to randomization, due to their...
- Current or recent (within the last 6 months) chemotherapy or immunotherapy for cancer treatment.
See the full eligibility criteria
Who can join
- 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.
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.