A Study of Glutamine to Treat Intestinal Permeability in Functional Dyspepsia

A Randomized, Placebo-Controlled Trial Assessing the Effect of Glutamine on Intestinal Permeability and Symptoms in Patients With Functional Dyspepsia

The purpose of this research is to collect data from patients diagnosed with functional dyspepsia who are treated with glutamine and describe safety and treatment results compared to patients taking a placebo. Glutamine, an essential amino acid in humans, is an important energy source for cells lining the gastrointestinal tract and has been shown to play an important role in regulating the strength of the intestinal wall.

Study Overview

• Status: Recruiting
• Conditions: Functional Dyspepsia
• Intervention / Treatment: Drug: Glutamine; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Torsak Vimoktayon; Phone Number: 904-953-3238; Email: Vimoktayon.Torsak@mayo.edu

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32258
      • Recruiting
      • Torsak Vimoktayon
      • Contact: Torsak Vimoktayon; Phone Number: 904-233-3674; Email: vimoktayon.torsak@mayo.edu
      • Contact: Wendi Lehman

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Meet Rome IV criteria for functional dyspepsia (https://theromefoundation.org/rome-iv/rome-iv-criteria/)
• Patients will generally be in good health. During initial evaluation, patients' symptoms will be assessed and patients categorized into either the PDS, EPS or mixed subtype of FD.

Exclusion Criteria:

• Significant comorbid illness
• Symptoms are thought to represent an organic disorder (e.g., peptic ulcer disease, hepatitis, pancreatitis, inflammatory bowel disease, type I diabetes, a known malignancy, radiation-induced injury, an active infection, vasculitis, celiac disease), or if the patients have known esophagitis, eosinophilic esophagitis or H. pylori.
• Prior surgery to the esophagus, stomach or duodenum will be excluded, as will those taking proton pump inhibitors (PPIs), opioids, corticosteroids and those taking regular (daily) antihistamines, non-steroidal anti-inflammatory drugs (NSAIDs), or mast-cell stabilizing agents within the prior 2 weeks. Of note, patients taking PPIs will be given the opportunity to discontinue their PPI in favor of famotidine 20 mg daily for 2 weeks before enrollment.
• Known allergies to lactulose: mannitol.
• Active tobacco use and excessive alcohol use (defined as 8 or more drinks per week for women or 15 or more drinks per week for men; http://ww.cdc.gov)
• Co-existing IBS will be allowed to enter the study as long as symptoms are not predominant.
• Hepatic and renal impairment within the past 6 months. Defined as AST/ALT > 2X ULN, Total Bilirubin > 2 X ULN, Estimated Glomerular Filtration Rate (eGFR) of < 60 mL/min/BSA.
• Diagnosed with galactosemia.
• Pregnant or breastfeeding women.
• Patients with documented or reported lactose intolerance.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Glutamine Group; Subjects will receive glutamine for 28 days.	Drug: Glutamine; 5 gram powder, one rounded teaspoon, dissolved in 8 ounces of water or juice prior to drinking) taken orally three times per day
Placebo Comparator: Placebo Group; Subjects will receive placebo for 28 days.	Drug: Placebo; Lactose powder dissolved in 8 ounces of water or juice prior to drinking, taken orally three times per day. Looks exactly like the study drug, but it contains no active ingredient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Functional Dyspepsia symptoms	Assessed by the validated self-reported Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index (PAGI-SYM) questionnaire total score. 20-item questionnaire measuring severity of symptoms related to gastrointestinal problem on scale from 0 = no symptoms to 5=very severe. Total score range 0-100 with higher score indicating greater severity of gastrointestinal symptoms.	Baseline, 4 weeks
Change in symptoms of bloating	Assessed by the validated self-reported Mayo Bloating questionnaire (MBQ). 45-item questionnaire to describe symptoms of bloating and distension.	Baseline, 4 weeks
Changes in small bowel intestinal permeability	Assessed using the validated lactulose: mannitol urine test	Baseline, 4 weeks
Adverse Events	Number of adverse events (serious and non-serious) reported	4 weeks

Collaborators and Investigators

• Sponsor: David J. Cangemi
• Investigators: Principal Investigator: David Cangemi, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: December 9, 2022
• First Submitted That Met QC Criteria: December 9, 2022
• First Posted (Actual): December 19, 2022

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Dyspepsia
• Other Study ID Numbers: 22-004343

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No