A Study Evaluating the Impact of Regular FODMAP-targeting Digestive Enzyme Blend Use on Gastrointestinal Symptoms in Individuals With Self-Reported Bloating

Exclusion Criteria30

• 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.