Loading clinical trials...

A Study of Glutamine to Treat Intestinal Permeability in Functional Dyspepsia | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

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

NCT05655819•David J. Cangemi

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Torsak Vimoktayon

Jacksonville, Florida, United States

Key Dates

Start Date

February 16, 2023

Primary Completion Date

December 31, 2025

Completion Date

December 31, 2025

Last Updated

February 3, 2026

Enrollment

ACTUAL participants

Conditions

Functional Dyspepsia

Interventions

Glutamine

DRUG

Placebo

DRUG

Efficacy of Clostridium Butyricum in Alleviating Anxiety and Depression in Patients With Functional Dyspepsia

NCT07182890

Functional DyspepsiaProbiotics+2 more

View study

RECRUITING

Bio-electrical Impedance Analysis in Patients With Functional Dyspepsia

NCT07196735

Functional DyspepsiaBIA+3 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 3, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study of Glutamine to Treat Intestinal Permeability in Functional Dyspepsia

Inclusion Criteria

Exclusion Criteria

Efficacy of Clostridium Butyricum in Alleviating Anxiety and Depression in Patients With Functional Dyspepsia

Bio-electrical Impedance Analysis in Patients With Functional Dyspepsia

The Brain-Heart-Gut Connection

Enabling Microbiomics- Driven Personalized Nutrition

Cerebral Cortical Influences on Autonomic Function

Trial of Itopride 150mg Once a Day Versus Itopride 50 mg Thrice a Day; in Patients With Functional Dyspepsia