Glutamine for Indigestion

Recruiting at 1 trial location

Overseen By Torsak Vimoktayon

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: David J. Cangemi

Must not be taking: PPIs, Opioids, Corticosteroids, NSAIDs

Disqualifiers: Significant illness, Organic disorder, Surgery, others

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

12 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether glutamine, an important amino acid, can improve symptoms of functional dyspepsia, a type of chronic indigestion. Participants will receive either glutamine or a placebo (a harmless pill with no active ingredients) for 28 days to assess differences in symptom relief and safety. Individuals with ongoing stomach discomfort that meets the criteria for functional dyspepsia, and who are generally healthy, might be suitable candidates. As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

You may need to stop taking certain medications like proton pump inhibitors (PPIs), opioids, corticosteroids, daily antihistamines, NSAIDs, or mast-cell stabilizing agents at least 2 weeks before joining the trial. If you're on PPIs, you can switch to famotidine 20 mg daily for 2 weeks before enrolling.

Is there any evidence suggesting that glutamine is likely to be safe for humans?

A previous study found that patients who received glutamine after stomach surgery tolerated it well and experienced no major side effects. Only a few participants (3 out of 14) reported minor issues such as nausea, hiccups, or gas. This indicates that glutamine is generally safe. As an important nutrient for the gut, glutamine helps maintain the strength of the intestinal wall, which could benefit individuals with functional dyspepsia, a type of indigestion. Since this trial is in its early stages, it primarily focuses on safety, and the study's findings suggest that glutamine is generally safe to use. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for indigestion?

Unlike the typical treatments for indigestion, which often include antacids or proton pump inhibitors, glutamine offers a unique approach by potentially enhancing gut health and repairing the intestinal lining. Researchers are excited about glutamine because it is a naturally occurring amino acid in the body, which might lead to fewer side effects compared to traditional medications. Additionally, its ability to support the integrity of the intestinal barrier could offer a more holistic improvement in digestive health, making it a promising option for those seeking alternatives to conventional indigestion remedies.

What evidence suggests that glutamine might be an effective treatment for indigestion?

Research has shown that glutamine can improve digestive health. Studies have found that it strengthens the gut wall by reducing its permeability, which might alleviate symptoms like stomach pain and discomfort. In this trial, participants in the Glutamine Group will receive glutamine for 28 days to evaluate its effects on digestive symptoms. Overall, these findings suggest that glutamine might benefit people with functional dyspepsia, a condition causing indigestion and stomach discomfort. ^{1 2 4 6 7}

Who Is on the Research Team?

David Cangemi, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for people in good health with functional dyspepsia, which causes indigestion. They must fit the Rome IV criteria for this condition and can't have allergies to certain sugars, liver or kidney problems, be pregnant or breastfeeding, use tobacco heavily, drink excessively, or have had recent stomach surgery.

Inclusion 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.

You have symptoms of a condition called functional dyspepsia that match the criteria outlined in the Rome IV guidelines.

Exclusion Criteria

Known allergies to lactulose: mannitol.

Diagnosed with galactosemia.

Pregnant or breastfeeding women.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either glutamine or placebo for 28 days

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Glutamine
• Placebo

Trial Overview

Researchers are testing if glutamine—an amino acid that fuels intestinal cells—can improve symptoms of functional dyspepsia compared to a placebo. The study will measure safety and effectiveness by observing changes in intestinal permeability.

How Is the Trial Designed?

Group I: Glutamine Group Active Control 1 Intervention

Subjects will receive glutamine for 28 days.

Group II: Placebo Group Placebo Group 1 Intervention

Subjects will receive placebo for 28 days.

Who Is Running the Clinical Trial?

David J. Cangemi

Lead Sponsor

Trials

1

Recruited

10+

Citations

1.

mayo.edu

mayo.edu/research/clinical-trials/diseases-conditions/functional-dyspepsia

Functional Dyspepsia Clinical Trials

The overarching aim of this study is to collect data for patients treated with glutamine and describe safety and treatment results. It will also investigate the ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9549483/

A Randomized Placebo-Controlled Trial of Dietary Glutamine ...

Glutamine significantly decreased the proportion of subjects who met or exceeded the criterion (a 50-point decrease on the IBS-SS) for a positive response for ...

3.

link.springer.com

link.springer.com/article/10.1007/s00726-024-03420-7

A systematic review and meta-analysis of clinical trials on ...

In conclusion, glutamine supplementation in doses of more than 30 mg/day for less than 2 weeks, significantly reduced intestinal permeability.

4.

mayo.edu

mayo.edu/research/clinical-trials/cls-20541619

Clinical Trials

The overarching aim of this study is to collect data for patients treated with glutamine and describe safety and treatment results.

5.

app.trialscreen.org

app.trialscreen.org/trials/phase-1-2-functional-dyspepsia-glutamine-to-treat-intestinal-permeability-trial-nct05655819

A Study of Glutamine to Treat Intestinal Permeability in ...

Participants may experience improvements in their digestive symptoms, including reduced abdominal discomfort or pain, if the glutamine ...

6.

centerwatch.com

centerwatch.com/clinical-trials/listings/NCT05655819/a-study-of-glutamine-to-treat-intestinal-permeability-in-functional-dyspepsia

A Study of Glutamine to Treat Intestinal Permeability in ...

The purpose of this research is to collect data from patients diagnosed with functional dyspepsia who are treated with glutamine and describe safety and ...

7.

sciencedirect.com

sciencedirect.com/science/article/pii/S0022316622096948

Nonnutritive Effects of Glutamine

... gastrointestinal surgery was well tolerated and metabolically safe (57). Only minor signs of nausea, hiccups, and flatulence (3/14 patients) were observed ...