What side effects are associated with this type of intervention?

Common treatments for indigestion include proton pump inhibitors (PPIs) like omeprazole, antispasmodics such as dicyclomine, and amino acids like glutamine. PPIs can cause side effects such as headache, nausea, diarrhea, abdominal pain, and potential long-term risks like vitamin B12 deficiency and bone fractures. Antispasmodics may lead to dry mouth, dizziness, blurred vision, and constipation. Glutamine, being an amino acid, is generally well-tolerated but can occasionally cause mild side effects like nausea, vomiting, and abdominal pain.

What prior FDA approvals exist?

FDA-approved treatments for indigestion often include proton pump inhibitors (PPIs) like omeprazole and esomeprazole, which reduce stomach acid production. While glutamine itself is not specifically mentioned as FDA-approved for indigestion, its role in supporting gastrointestinal health is similar to other treatments that focus on strengthening the intestinal wall and improving gut function. For example, N-acetylcysteine (NAC) has been studied for its antioxidant properties and potential benefits in gastrointestinal conditions. Additionally, mesalamine is used for inflammatory bowel diseases, which can overlap with symptoms of indigestion.

What other types of research exist?

One promising alternative to glutamine for indigestion patients is L-arginine. Studies have shown that L-arginine can enhance plasma concentrations of pancreatic glucagon, which plays a role in regulating gastric acid secretion. Additionally, glucagon-like peptide 1 (GLP-1) variants, particularly GLP-1-(7-36) amide, have demonstrated potent effects on gastrointestinal cell function and may offer therapeutic benefits. These alternatives could be considered in consultation with a healthcare provider.

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Amino Acid

Glutamine for Indigestion

Phase 1 & 2

Recruiting

Led By David Cangemi, MD

Research Sponsored by David J. Cangemi

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks

Summary

This trial is studying the effects of glutamine on patients with functional dyspepsia, a condition causing stomach discomfort. Glutamine is a protein building block that provides energy to gut cells and helps keep the gut lining strong. Researchers want to see if glutamine can improve symptoms and compare its safety and effectiveness. Glutamine has been studied for its potential benefits in reducing neurotoxicity in patients receiving chemotherapy, showing some degree of benefit in reducing symptoms like paresthesias and constipation.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly listed here, potential side effects may include digestive discomfort since glutamine affects gut function. However, as an amino acid naturally present in the body, it's generally considered safe at recommended doses.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adverse Events

Change in Functional Dyspepsia symptoms

Change in symptoms of bloating

+1 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Glutamine GroupActive Control1 Intervention

Subjects will receive glutamine for 28 days.

Group II: Placebo GroupPlacebo Group1 Intervention

Subjects will receive placebo for 28 days.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Glutamine, an essential amino acid, is a key treatment for indigestion as it provides energy to gastrointestinal cells and strengthens the intestinal wall, preventing harmful substances from exacerbating symptoms. This is crucial for maintaining a healthy gut barrier. Other common treatments include antacids, H2-receptor antagonists, and proton pump inhibitors, which alleviate indigestion by neutralizing or reducing stomach acid production.

Arteriovenous differences for amino acids across control and acid-secreting rat stomach in vivo.Acid-induced release of platelet-activating factor by human esophageal mucosa induces inflammatory mediators in circular smooth muscle.[Duodenogastric reflux in patients with irritable bowel syndrome treated with wheat bran].