zypan functional dyspepsia

Conditions: Dyspepsia

Summary: the purpose of this study is to determine the effects of a readily available dietary supplement on quality of life and digestion in adults with functional dyspepsia.


Eligibility criteria:
inclusion criteria: * ● adults 18-70 years of age (inclusive) * a self-reported history of symptoms consistent with functional dyspepsia (per rome iv criteria - see telephone screening), and self-reported absence of organic disease and infection (e.g., helicobacter pylori) with or without a formal diagnosis by a healthcare professional. * adults ≥ 60 years of age must have had a normal upper gastrointestinal endoscopy * 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 symptoms consistent 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 dose for a minimum of three months) * on a stable dose of dietary supplements for at least one month prior to enrollment * willing to avoid initiation of new supplements and/or medications unless otherwise 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 the principal 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 criteria: * ● a self-reported history of peptic and/or duodenal ulcers, h. pylori infection, gastroesophageal reflux disease (gerd) explained by upper endoscopy, irritable bowel syndrome (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 dietary supplements * current use of prescribed proton-pump inhibitors * current use of drugs that interfere with gastrointestinal motility, including prokinetic agents. * history of previous abdominal surgery, including gastric surgery, excluding appendectomy. * individuals with chronic kidney or liver disease, cancer, colorectal disease and/or other rare disorders that at the discretion of the pi or clinical investigator may impact their safety or confound trial results * current involvement or within 14 days prior to screening of a significant diet or weight loss program (such as nutrisystem, jenny craig, atkin's or other low-carb diet programs) or very low-calorie liquid diet programs (such as optifast, medifast, and/or hmr) * hospitalization (for any reason other than a scheduled medical procedure unrelated 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, or participated in another interventional research study within 14 days of screening