Zypan Functional Dyspepsia

Dyspepsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06320379
• Other study ID #: RB071522
• Status: Recruiting
• Phase: N/A
• Start date: March 15, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: National University of Natural Medicine
• Contact: Ryan Bradley, ND, MPH
• Phone: 503-502-1862
• Email: rbradley[@]nunm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: December 31, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyspepsia

Intervention

Dietary Supplement:
• Zypan
The study product is a dietary supplement manufactured by Standard Process Inc (i.e., Zypan®). One serving (i.e., two tablets) contains a proprietary blend (595 mg) of the following: Betaine hydrochloride, bovine pancreas Cytosol™ extract, pepsin (1:10,000), pancreatin (3x), stearic acid (vegetable source), ammonium chloride, bovine spleen, and ovine spleen. Non active ingredients will include cellulose and calcium stearate. Participants will be instructed to take two tablets three times daily with meals
• Placebo Comparator
The control supplement will not contain any of the active ingredients in Zypan® and will also be manufactured by Standard Process Inc. Two tablets will contain 435 mg of cellulose (42%), 288 mg rice bran powder (28%), 201 mg of calcium lactate powder (19.5%*), 103 mg citric acid (10%), and 2.6 mg calcium stearate (0.25%)

Locations

Country	Name	City	State
United States	Helfgott Research Institute	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
National University of Natural Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Microbiota Relative Abundance and Composition	Objective measure of amount and types of gut microbes	Baseline
Other	Microbiota Relative Abundance and Composition	Objective measure of microbiota abundance, composition, diversity	Week 4
Other	Blood glucose	Blood concentrations of glucose	Baseline
Other	Blood glucose	Blood concentrations of glucose	Week 4
Other	Urea Nitrogen	Blood concentrations of Urea Nitrogen	Baseline
Other	Urea Nitrogen	Blood concentrations of Urea Nitrogen	Week 4
Other	Creatinine	Blood concentrations of creatinine	Baseline
Other	Creatinine	Blood concentrations of creatinine	Week 4
Other	Urea Nitrogen to creatinine ratio	ratio of blood concentrations of urea nitrogen to creatinine	baseline
Other	Urea Nitrogen to creatinine ratio	ratio of blood concentrations of urea nitrogen to creatinine	Week 4
Other	Sodium	blood concentrations of Sodium	Baseline
Other	Sodium	blood concentrations of Sodium	Week 4
Other	Potassium	blood concentrations of Potassium	Baseline
Other	Potassium	blood concentrations of Potassium	Week 4
Other	Chloride	blood concentrations of Chloride	Baseline
Other	Chloride	blood concentrations of Chloride	Week 4
Other	Carbon Dioxide	blood concentration of carbon dioxide	baseline
Other	Carbon Dioxide	blood concentration of carbon dioxide	week 4
Other	Calcium	blood concentration of calcium	Baseline
Other	Calcium	blood concentration of calcium	Week 4
Other	Total Protein	Total protein in blood	Baseline
Other	Total Protein	Total protein in blood	Week 4
Other	Albumin	Concentration of albumin in blood	Baseline
Other	Albumin	Concentration of albumin in blood	Week 4
Other	Globulin	Concentration of globulin in blood	baseline
Other	Globulin	Concentration of globulin in blood	Week 4
Other	Albumin to Globulin ratio	Ratio of the blood concentrations of albumin to globulin	Baseline
Other	Albumin to Globulin ratio	Ratio of the blood concentrations of albumin to globulin	Week 4
Other	Bilirubin	Concentrations of bilirubin in blood	baseline
Other	Bilirubin	Concentrations of bilirubin in blood	Week 4
Other	Alkaline Phosphatase	Concentrations of alkaline phosphatase in blood	baseline
Other	Alkaline Phosphatase	Concentrations of alkaline phosphatase in blood	Week 4
Other	aspartate aminotransferase	Concentrations of aspartate aminotransferase in blood	Baseline
Other	aspartate aminotransferase	Concentrations of aspartate aminotransferase in blood	Week 4
Other	Alanine aminotransferase	Concentrations of Alanine aminotransferase in blood	baseline
Other	Alanine aminotransferase	Concentrations of Alanine aminotransferase in blood	Week 4
Other	Estimated glomerular filtration rate	glomerular filtration rate per 1.73 sqM estimated	baseline
Other	Estimated glomerular filtration rate	glomerular filtration rate per 1.73 sqM estimated	Week 4
Other	White blood cell count	Amount of leukocytes in blood	baseline
Other	White blood cell count	Amount of leukocytes in blood	Week 4
Other	Red blood cell count	Amount of erythrocytes in blood	baseline
Other	Red blood cell count	Amount of erythrocytes in blood	Week 4
Other	Hemoglobin	Amount of hemoglobin in blood	baseline
Other	Hemoglobin	Amount of hemoglobin in blood	Week 4
Other	Hematocrit	Amount of hematocrit in blood	baseline
Other	Hematocrit	Amount of hematocrit in blood	Week 4
Other	Mean corpuscular volume	Mean corpuscular volume of erythrocytes	baseline
Other	Mean corpuscular volume	Mean corpuscular volume of erythrocytes	Week 4
Other	Mean corpuscular hemoglobin	Mean corpuscular hemoglobin of erythrocytes	baseline
Other	Mean corpuscular hemoglobin	Mean corpuscular hemoglobin of erythrocytes	Week 4
Other	Mean corpuscular hemoglobin concentration	Mean corpuscular hemoglobin concentration of erythrocytes	baseline
Other	Mean corpuscular hemoglobin concentration	Mean corpuscular hemoglobin concentration of erythrocytes	Week 4
Other	Erythrocyte distribution width	Erythrocyte distribution width	baseline
Other	Erythrocyte distribution width	Erythrocyte distribution width	Week 4
Other	Platelet count	amount of platelets in blood	baseline
Other	Platelet count	amount of platelets in blood	Week 4
Other	Neutrophils	amount of neutrophils in blood	baseline
Other	Neutrophils	amount of neutrophils in blood	Week 4
Other	Band Neutrophils	Neutrophils band form per 100 leukocytes	baseline
Other	Band Neutrophils	Neutrophils band form per 100 leukocytes	Week 4
Other	Absolute band neutrophils	Amount of Neutrophils band form	baseline
Other	Absolute band neutrophils	Amount of Neutrophils band form	Week 4
Other	Metamyelocytes	Amount of metamyelocytes per 100 leukocytes	baseline
Other	Metamyelocytes	Amount of metamyelocytes per 100 leukocytes	Week 4
Other	Absolute Metamyelocytes	Amount of metamyelocytes	baseline
Other	Absolute Metamyelocytes	Amount of metamyelocytes	Week 4
Other	Myelocytes	Amount of metamyelocytes per 100 leukocytes	baseline
Other	Myelocytes	Amount of metamyelocytes per 100 leukocytes	Week 4
Other	Absolute Myelocytes	Amount of myelocytes	baseline
Other	Absolute Myelocytes	Amount of myelocytes	Week 4
Other	Promyelocytes	Amount of promyelocytes per 100 leukocytes	baseline
Other	Promyelocytes	Amount of promyelocytes per 100 leukocytes	Week 4
Other	Absolute Promyelocytes	Amount of promyelocytes	baseline
Other	Absolute Promyelocytes	Amount of promyelocytes	Week 4
Other	Absolute Neutrophils	Amount of neutrophils in blood	baseline
Other	Absolute Neutrophils	Amount of neutrophils in blood	Week 4
Other	Lymphocytes	Amount of lymphocytes in blood per 100 leukocytes	baseline
Other	Lymphocytes	Amount of lymphocytes in blood per 100 leukocytes	Week 4
Other	Reactive Lymphocytes	Amount of reactive lymphocytes in blood per 100 leukocytes	baseline
Other	Reactive Lymphocytes	Amount of reactive lymphocytes in blood per 100 leukocytes	Week 4
Other	Absolute Lymphocytes	Amount of reactive lymphocytes in blood	baseline
Other	Absolute Lymphocytes	Amount of reactive lymphocytes in blood	Week 4
Other	Monocytes	Amount of monocytes in blood per 100 leukocytes	baseline
Other	Monocytes	Amount of monocytes in blood per 100 leukocytes	Week 4
Other	Absolute monocytes	Amount of monocytes in blood	baseline
Other	Absolute monocytes	Amount of monocytes in blood	Week 4
Other	Eosinophils	Amount of eosinophils in blood per 100 leukocytes	baseline
Other	Eosinophils	Amount of eosinophils in blood per 100 leukocytes	Week 4
Other	Absolute Eosinophils	Amount of eosinophils in blood	baseline
Other	Absolute Eosinophils	Amount of eosinophils in blood	Week 4
Other	Basophils	Amount of basophils in blood per 100 leukocytes	baseline
Other	Basophils	Amount of basophils in blood per 100 leukocytes	Week 4
Other	Absolute Basophils	Amount of basophils in blood	baseline
Other	Absolute Basophils	Amount of basophils in blood	Week 4
Other	Blasts	Amount of blasts in blood per 100 leukocytes	baseline
Other	Blasts	Amount of blasts in blood per 100 leukocytes	Week 4
Other	Absolute Blasts	Amount of blasts in blood	baseline
Other	Absolute Blasts	Amount of blasts in blood	Week 4
Other	Nucleated red blood cells	Amount of nucleated erythrocytes per 100 leukocytes	baseline
Other	Absolute Nucleated red blood cells	Amount of nucleated erythrocytes in blood	baseline
Other	Absolute Nucleated red blood cells	Amount of nucleated erythrocytes in blood	Week 4
Other	Platelet mean volume	Mean volume of platelets in blood	baseline
Other	Platelet mean volume	Mean volume of platelets in blood	Week 4
Primary	Protein Assimilation	Concentrations of Amino Acids in Blood	Baseline
Primary	Protein Assimilation	Concentrations of Amino Acids in Blood	Week 4
Secondary	Mineral concentrations in blood	Mineral concentrations in blood as measured by Genova Diagnostics NutrEval	Baseline
Secondary	Mineral concentrations in blood	Mineral concentrations in blood as measured by Genova Diagnostics NutrEval	Week 4
Secondary	Fat-soluble vitamin concentration in blood	Fat-soluble vitamin concentrations in blood as measured by Genova Diagnostics NutrEval	Baseline
Secondary	Fat-soluble vitamins	Fat-soluble vitamin concentrations in blood as measured by Genova Diagnostics NutrEval	Week 4
Secondary	Leeds Dyspepsia Questionnaire	Subjective measure of digestive symptoms	Baseline
Secondary	Leeds Dyspepsia Questionnaire	Subjective measure of digestive symptoms	Week 4
Secondary	Patient Reported Outcomes Measurement Information System (PROMIS)-29 Physical Function Subscale	Subjective measure of Quality of life related to physical function	Baseline
Secondary	Patient Reported Outcomes Measurement Information System (PROMIS)-29 Physical Function Subscale	Subjective measure of Quality of life related to physical function	Week 4