Phase
Condition
Colic
Heartburn
Bowel Dysfunction
Treatment
Zypan
Placebo Comparator
Clinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
● Adults 18-70 years of age (inclusive)
A self-reported history of symptoms consistent with Functional Dyspepsia (perRome IV criteria - See Telephone Screening), and self-reported absence oforganic disease and infection (e.g., Helicobacter pylori) with or without aformal diagnosis by a healthcare professional.
Adults ≥ 60 years of age must have had a normal upper gastrointestinalendoscopy
Willing to be randomized to take a daily dietary supplement or placebo over the 4-week study period
Not taken antibiotics or other drugs prescribed specifically for symptomsconsistent with Functional Dyspepsia (per Rome IV criteria) for a period up to 1 month before the beginning of the study.
On a stable dose of all medications prior to study entry (i.e., consistent dosefor a minimum of three months)
On a stable dose of dietary supplements for at least one month prior toenrollment
Willing to avoid initiation of new supplements and/or medications unlessotherwise indicated by a healthcare professional
Able to communicate via email, complete computer-administered questionnaires,and to read and write in English.
Approved to be eligible for study participation at the discretion of thePrincipal Investigators, after review of the Formal Eligibility Screen results.
Non-smokers (including tobacco and cannabis products, combusted or vaporized)
Willing to provide written informed consent and to follow the required protocol
Exclusion
Exclusion Criteria:
● A self-reported history of peptic and/or duodenal ulcers, H. pylori infection,gastroesophageal reflux disease (GERD) explained by upper endoscopy, irritable bowelsyndrome (IBS), and other chronic GI disorders.
Positive fecal occult blood test (FOBT) at the clinical screening visit
Current use of digestive enzyme and/or betaine HCL-containing dietarysupplements
Current use of prescribed proton-pump inhibitors
Current use of drugs that interfere with gastrointestinal motility, includingprokinetic agents.
History of previous abdominal surgery, including gastric surgery, excludingappendectomy.
Individuals with chronic kidney or liver disease, cancer, colorectal diseaseand/or other rare disorders that at the discretion of the PI or ClinicalInvestigator may impact their safety or confound trial results
Current involvement or within 14 days prior to screening of a significant dietor weight loss program (such as NutriSystem, Jenny Craig, Atkin's or otherlow-carb diet programs) or very low-calorie liquid diet programs (such asOptifast, Medifast, and/or HMR)
Hospitalization (for any reason other than a scheduled medical procedureunrelated to Functional Dyspepsia) within 3 months prior to screening
Malignancy within the last 5 years (with the exception of basal cell carcinoma,squamous cell carcinoma, and/or carcinoma in situ of the cervix)
Intake of ≥ 2 standardized alcohol-containing beverages per day, 14 per week,or ≥4 in any single day within the past 14 days.
Individuals who do not consume, or are allergic to, animal products
Smoking tobacco or nicotine products (combusted or vaporized)
Use of illicit drugs/substances (such as but not limited to cocaine,phencyclidine (PCP), and methamphetamine) within 14 days of screening
Currently participating in another interventional research study, orparticipated in another interventional research study within 14 days ofscreening
Study Design
Connect with a study center
Helfgott Research Institute
Portland, Oregon 97201
United StatesActive - Recruiting
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