Clinical trial

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

Name

22-004343

Description

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.

Trial arms

Trial start

2023-02-16

Estimated PCD

2024-12-01

Trial end

2024-12-01

Status

Recruiting

Phase

Early phase I

Treatment

Glutamine

5 gram powder, one rounded teaspoon, dissolved in 8 ounces of water or juice prior to drinking) taken orally three times per day

Arms:

Glutamine Group

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.

Arms:

Placebo Group

Size

Primary endpoint

Change in Functional Dyspepsia symptoms

Baseline, 4 weeks

Change in symptoms of bloating

Baseline, 4 weeks

Changes in small bowel intestinal permeability

Baseline, 4 weeks

Adverse Events

4 weeks

Eligibility criteria

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}

Updated at

2024-03-12

1 organization

1 product

1 drug

1 indication

Organization

Product

Indication

Drug