Zypan Functional Dyspepsia | NCT06320379

NCT06320379

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Label	Type	Description	Intervention Names
Zypan	Experimental		Dietary Supplement: Zypan
Placebo	Placebo Comparator		Dietary Supplement: Placebo Comparator

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Zypan	Dietary Supplement	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

Outcomes Module

Measure	Description	Time Frame
Protein Assimilation	Concentrations of Amino Acids in Blood	Baseline
Protein Assimilation	Concentrations of Amino Acids in Blood	Week 4

Secondary Outcomes

Measure	Description	Time Frame
Mineral concentrations in blood	Mineral concentrations in blood as measured by Genova Diagnostics NutrEval	Baseline
Mineral concentrations in blood	Mineral concentrations in blood as measured by Genova Diagnostics NutrEval

Other Outcomes

Measure	Description	Time Frame
Microbiota Relative Abundance and Composition	Objective measure of amount and types of gut microbes	Baseline
Microbiota Relative Abundance and Composition	Objective measure of microbiota abundance, composition, diversity

Eligibility Module

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

Name	Role	Phone	Extension	Email
Ryan Bradley, ND, MPH	Contact	503-502-1862		rbradley@nunm.edu
Anders Gundersen, MS	Contact	503-552-1752		agundersen@nunm.edu

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms