Zypan Functional Dyspepsia

Launched by NATIONAL UNIVERSITY OF NATURAL MEDICINE · Mar 13, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring the effects of a dietary supplement on adults with a condition called functional dyspepsia, which often causes discomfort in the upper abdomen and can affect daily life. The study aims to see if this supplement can improve both digestion and overall quality of life for those experiencing these symptoms.

To be eligible, participants should be between 18 and 70 years old, have a history of symptoms related to functional dyspepsia, and not have any serious gastrointestinal diseases. Individuals must be willing to take either the supplement or a placebo (a non-active version) daily for four weeks. This means that if you join the study, you'll be randomly assigned to one of these two groups. Participants will also need to be non-smokers and free from certain medical conditions that could affect their safety in the study. Throughout the trial, you will be asked to complete questionnaires to share your experience. If you’re interested and meet the criteria, this could be a valuable opportunity to help researchers learn more about managing dyspepsia.

Gender

ALL

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