L-glutamine for Diverticulosis

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether L-glutamine, an amino acid, is safe and effective for individuals with diverticulosis, a condition where small pouches form in the colon. Participants will take L-glutamine powder twice daily for 48 weeks to assess its impact on their condition. The trial seeks individuals who have had a colonoscopy showing 5-10 pouches in specific parts of the colon but no more than 40 pouches overall. Those with doctor-confirmed diverticulosis who meet these criteria may find this trial suitable. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this new treatment.

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.

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

Research has shown that L-glutamine is generally safe for people. As an amino acid, it helps build proteins in the body and supports both the immune system and digestion. Studies indicate it is not considered dangerous and usually doesn't cause serious health problems. However, some people might experience mild side effects like constipation, nausea, or headaches.

Long-term use of L-glutamine might alter how the body handles other amino acids and ammonia. It could also affect the immune system or tumor growth, though these effects are not fully understood yet. Overall, research suggests L-glutamine is safe for most people, but monitoring for any side effects is important. Always consult a healthcare provider before starting any new treatment.12345

Why do researchers think this study treatment might be promising?

Most treatments for diverticulosis focus on managing symptoms through diet changes, fiber supplements, and sometimes antibiotics. But L-glutamine works differently by targeting gut health at a fundamental level. L-glutamine is an amino acid that helps strengthen the intestinal lining and reduce inflammation, which could address the underlying issues rather than just the symptoms. Researchers are excited about L-glutamine because it has the potential to improve gut integrity and overall digestive health, offering a novel approach compared to current strategies.

What evidence suggests that L-glutamine might be an effective treatment for diverticulosis?

Research has shown that L-glutamine can help maintain a healthy gut, which is important for people with diverticulosis. One study found that after just 14 days of taking glutamine, participants experienced a positive change in the balance of gut bacteria, suggesting that glutamine might improve gut health. In another study, L-glutamine reduced pain episodes in people with sickle cell disease over 48 weeks, indicating it might also ease symptoms in other conditions. While direct evidence for its effects on diverticulosis is not yet available, its benefits for gut health and symptom relief in other conditions are promising. Participants in this trial will receive L-glutamine oral powder, 15 grams twice daily for 48 weeks, to evaluate its effects.678910

Who Is on the Research Team?

YL

Yutaka L Niihara, MD

Principal Investigator

Emmaus Medical, Inc.

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

  • L-glutamine
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: L-glutamineExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Emmaus Medical, Inc.

Lead Sponsor

Trials
8
Recruited
380+

Published Research Related to This Trial

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]
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]

Citations

The role of glutamine in supporting gut health and ...After 14 days of supplementation, the glutamine group showed a significantly reduced Firmicutes to Bacteroidetes ratio, a result that has also been reflected ...
A comprehensive insight into the effect of glutamine ...Glutamine supplementation could improve glycemic control and levels of incretins (such as GLP-1 and GIP) in diabetes mellitus.
A Phase 3 Trial of l-Glutamine in Sickle Cell DiseaseOur trial showed that the median number of pain crises over 48 weeks was lower among the patients who received l-glutamine than among those who ...
Glutamine: Metabolism and Immune Function ...Results concerning skeletal and liver muscles were recorded at protein and gene expression levels. In addition, other genes were highly responsive to glutamine, ...
L-Glutamine is better for treatment than prevention in ...Conclusion: The therapeutic effect of L-glutamine after exhaustive exercise was more effective than preventive before exercise. Keywords ...
SAFETY DATA SHEETPhysical State. Solid. Appearance. White. Odor. Odorless. Odor Threshold. No information available. pH. 4 - 6. Melting Point/Range.
Safety Data SheetL-Glutamine is not classified as hazardous, with no known adverse physical or health effects not covered by the Hazard Communications Standard.
Glutamine: What It Is, Benefits & Side EffectsGlutamine is an amino acid, a protein building block, that supports the immune and digestive systems, and may reduce sickle cell complications.
9.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/22990615/
Side effects of long-term glutamine supplementationLong-term glutamine side effects include altered amino acid transport, metabolism, ammonia transport, and potential immune system and tumor growth effects.
L-glutamine: MedlinePlus Drug InformationL-glutamine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away: · constipation · nausea · headache ...
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