RECRUITING

Zypan Functional Dyspepsia

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Evaluating Changes in Quality of Life and Digestion in Functional Dyspepsia in Adults

Quick Facts

Study Start:2023-03-15

Study Completion:2024-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06320379

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* ● 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

Inclusion Criteria

Exclusion 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

* ● 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

Contacts and Locations

Study Contact

Ryan Bradley, ND, MPH

CONTACT

503-502-1862

rbradley@nunm.edu

Anders Gundersen, MS

CONTACT

503-552-1752

agundersen@nunm.edu

Study Locations (Sites)

Helfgott Research Institute

Portland, Oregon, 97201

United States

Collaborators and Investigators

Sponsor: National University of Natural Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-15

Study Completion Date2024-12-31

Study Record Updates

Study Start Date2023-03-15

Study Completion Date2024-12-31

Terms related to this study

Additional Relevant MeSH Terms

Dyspepsia