9 Participants Needed

L-glutamine Treatment in Patients With Diverticulosis

Recruiting at 2 trial locations
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. However, you cannot have taken any form of glutamine supplement within 30 days before the screening visit.

What data supports the effectiveness of the treatment L-glutamine?

Research shows that L-glutamine can help improve survival rates in critically ill patients and reduce infection rates and hospital stays in patients undergoing abdominal surgery. It is considered safe and may enhance recovery by supporting the immune system and maintaining tissue health.12345

Is L-glutamine generally safe for human use?

The research articles provided do not contain specific safety data for L-glutamine or its use in humans. Therefore, no relevant safety information is available from these sources.678910

How does the treatment L-glutamine differ from other treatments for this condition?

L-glutamine is unique because it is a conditionally essential amino acid that supports gut health and immune function, especially during stress or illness. Unlike other treatments, it can be taken orally, enterally, or parenterally, and it helps maintain intestinal integrity and prevent infections, which is particularly beneficial for patients undergoing trauma or surgery.1112131415

What is the purpose of this trial?

This trial is testing L-glutamine, a supplement that helps keep the gut healthy, on patients with diverticulosis. Diverticulosis causes small pouches in the colon that can be uncomfortable. The study aims to see if L-glutamine can reduce symptoms by supporting the gut lining and reducing inflammation. L-glutamine has been shown to reduce inflammation and support gut health in various gastrointestinal conditions.

Research Team

YL

Yutaka L Niihara, MD

Principal Investigator

Emmaus Medical, Inc.

Eligibility Criteria

Inclusion Criteria

You have uncomplicated diverticulosis confirmed by colonoscopy.
Patients who have given their free and written informed consent.
You have a minimum age of 50 years.\n
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive L-glutamine oral powder 15 grams twice daily

48 weeks
Visits at baseline, 6 months, and 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • L-glutamine
Participant Groups
1Treatment groups
Experimental Treatment
Group I: L-glutamineExperimental Treatment1 Intervention
Participants received L-glutamine oral powder 15 grams twice daily for 48 weeks

Find a Clinic Near You

Who Is Running the Clinical Trial?

Emmaus Medical, Inc.

Lead Sponsor

Trials
8
Recruited
380+

Findings from Research

A unique toxicology database has been established from data provided by 13 UK pharmaceutical companies, containing over 35,000 data fields from repeated-dose animal safety evaluations of 74 pharmaceutical compounds.
This database highlights the need to reassess traditional animal testing methods and suggests that computer-based toxicology databanks could improve the use of existing safety data for predicting human medicine safety.
A toxicology databank based on animal safety evaluation studies of pharmaceutical compounds.Lumley, CE., Walker, SR.[2019]
A laboratory alert system was evaluated for detecting adverse drug reactions (ADRs) in hospitalized patients, showing that the hyponatremia alert identified ADRs in 39.3% of cases, significantly more than the 3.3% found with the rhabdomyolysis alert.
The study suggests that using automated laboratory signals for pharmacovigilance can effectively detect ADRs, with the hyponatremia alert being more efficient, identifying 12 times more ADRs than the rhabdomyolysis alert, thus saving time in the evaluation process.
Utility of a Laboratory Alert System for Detecting Adverse Drug Reactions in Hospitalised Patients: Hyponatremia and Rhabdomyolysis.Valdés-Garicano, M., Mejía-Abril, G., Campodónico, D., et al.[2022]
The safety of marketed drugs is a significant concern, as some commonly prescribed medications can lead to serious or life-threatening side effects in patients.
The ChEMBL resource will provide a curated drug safety data set, including toxicity classifications and black box warnings, which will be freely available and regularly updated to aid in drug safety research and discovery.
Drug Safety Data Curation and Modeling in ChEMBL: Boxed Warnings and Withdrawn Drugs.Hunter, FMI., Bento, AP., Bosc, N., et al.[2023]

References

Outcome of critically ill patients after supplementation with glutamine. [2019]
A double blind, randomised, controlled trial of glutamine supplementation in parenteral nutrition. [2019]
Glutamine: from basic science to clinical applications. [2019]
The impact of perioperative glutamine-supplemented parenteral nutrition on outcomes of patients undergoing abdominal surgery: a meta-analysis of randomized clinical trials. [2015]
Safety and metabolic effects of L-glutamine administration in humans. [2017]
A toxicology databank based on animal safety evaluation studies of pharmaceutical compounds. [2019]
Evaluation of genotoxicity testing of FDA approved large molecule therapeutics. [2014]
Utility of a Laboratory Alert System for Detecting Adverse Drug Reactions in Hospitalised Patients: Hyponatremia and Rhabdomyolysis. [2022]
Drug Safety Data Curation and Modeling in ChEMBL: Boxed Warnings and Withdrawn Drugs. [2023]
ToxRefDB v2.1: update to curated in vivo study data in the Toxicity Reference Database. [2023]
11.United Statespubmed.ncbi.nlm.nih.gov
Thirteen-week oral toxicity study of L-glutamine in rats. [2013]
Glutamine supplementation in the newborn infant. [2023]
13.United Statespubmed.ncbi.nlm.nih.gov
Therapeutic considerations of L-glutamine: a review of the literature. [2013]
Regulation of the cellular and physiological effects of glutamine. [2019]
Gastrointestinal Tolerance of Low, Medium and High Dose Acute Oral l-Glutamine Supplementation in Healthy Adults: A Pilot Study. [2021]
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