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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
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 moreTrial 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.
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].
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].
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Who is running the clinical trial?
David J. CangemiLead Sponsor
David Cangemi, MDPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have certain medical conditions like ulcers, hepatitis, pancreatitis, or inflammatory bowel disease. You may also have known infections or specific digestive disorders that could affect the study results.You have a serious health condition other than the one being studied.You currently smoke or use tobacco products, and you drink alcohol excessively (more than 8 drinks per week for women or 15 drinks per week for men).If you have Irritable Bowel Syndrome (IBS), you can still join the study as long as your IBS symptoms are not the main problem you're experiencing.You have symptoms of a condition called functional dyspepsia that match the criteria outlined in the Rome IV guidelines.You have a known difficulty digesting lactose, which is found in dairy products.
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.