Phase
Condition
Colic
Ulcerative Colitis (Pediatric)
Lactose Intolerance
Treatment
FODMAP-targeting digestive enzyme blend
Placebo
Clinical Study ID
Ages > 18 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Individuals aged 18 years old or older
Screening score of >= 55 on the PROMIS Scale v1.1 - Gastrointestinal Gas andBloating 13a scale.
Screening severity score of >= 55 on the PROMIS Scale v1.0 - Gastrointestinal BellyPain 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 symptomsmust 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-inperiod.
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
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 orfunctional disorders, including but not limited to GI-directed Cognitive BehavioralTherapy (CBT), GI hypnotherapy, or other therapies for Disorders of Gut-BrainInteraction (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 knowneffects on gut motility and GI symptoms.
Current or recent (within the last 6 months) chemotherapy or immunotherapy forcancer treatment.
Current or planned use of any other digestive enzymes prescription orover-the-counter (OTC).
Chronic use (defined as daily use for >30 days within the last 90 days) of anymedication known to have substantial gastrointestinal side effects (e.g., diarrhea,constipation, nausea) that, in the opinion of the Principal Investigator, mayconfound 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 ofany probiotic, fiber supplement, laxative, stool softener, or antidiarrheal with adose change greater than 50% in the last 30 days or initiation or discontinuation ofa 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, orbreastfeeding
History of bariatric or other significant gastrointestinal surgery (e.g., smallbowel resection, total colectomy) that has permanently altered GI anatomy orfunction. 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 thatcould affect eligibility).
Have a significant illness, disease or condition which, in the opinion of theprincipal investigator, may impact their ability to participate in the study orimpact the study outcomes.
Self-reported known hypersensitivity or previous allergic reaction to cornand/or any previous reaction to digestive enzyme supplements (eg. Beano andLactaid)
Comorbid GI conditions: IBD - Ulcerative Colitis or Crohn's Disease,Microscopic Colitis, history of small bowel or colonic surgeries, Celiacdisease, 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. failedLFD in past)
Participants who are on or plan to initiate a major restrictive or eliminationdiet, or a structured weight-loss diet, during the study period.
No planned changes in diet, lifestyle or medications for IBS during studyperiod.
Use of any antibiotics, antifungals, or antivirals within 2 weeks prior torandomization.
Participants planning extended travel that would interfere with compliance orstudy procedures.
Are unlikely for any reason to be able to comply with the trial or consideredunsuited for participation in the study by the Principal Investigator.
Study Design
Study Description
Connect with a study center
People Science
Los Angeles, California 90045
United StatesActive - Recruiting

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