Zypan Functional Dyspepsia

Last updated: August 2, 2024
Sponsor: National University of Natural Medicine
Overall Status: Active - Recruiting

Phase

N/A

Condition

Colic

Heartburn

Bowel Dysfunction

Treatment

Zypan

Placebo Comparator

Clinical Study ID

NCT06320379
RB071522
  • Ages 18-70
  • All Genders

Study 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

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

Total Participants: 64
Treatment Group(s): 2
Primary Treatment: Zypan
Phase:
Study Start date:
March 15, 2023
Estimated Completion Date:
December 31, 2024

Connect with a study center

  • Helfgott Research Institute

    Portland, Oregon 97201
    United States

    Active - Recruiting

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