Zypan Functional Dyspepsia
Status unconfirmed · Not applicable · Has a placebo group
Conditions studied: Dyspepsia
In brief
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.
Key facts
- Study ID
- NCT06320379
- Run by
- National University of Natural Medicine
- People needed
- 64
- Starts
- 2023-03-15
- Expected to finish
- 2024-12-31
- Last updated by the study team
- 2024-08-06
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- ● 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
You may not qualify if…
- ● 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
Where it is running
- Helfgott Research Institute — Portland, Oregon, United States (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.