A Phase 1 interventional study of L-glutamine in Diverticulosis, Colonic, sponsored by Emmaus Medical, Inc.. Completed at 3 sites in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2023-02-16.
Sponsored by Emmaus Medical, Inc. · Phase 1, Interventional, and Treatment
The purpose of the study is evaluate the safety and efficacy of L-glutamine as a treatment for patients with diverticulosis.
After being informed about the study and potential risks, all patients giving written informed consent will undergo a 4 weeks screening period to determine eligibility for study entry. At Week 0, patients who meet eligibility requirements will be given L-glutamine (15 grams, twice daily)
23 studies on the registry are indexed under Diverticulosis, Colonic; 4 are open to participants now.
This study's enrollment of 9 is below the median of 80 across 13 interventional studies indexed under Diverticulosis, Colonic.
Browse Diverticulosis, Colonic studies →Emmaus Medical, Inc. is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants received L-glutamine oral powder 15 grams twice daily for 48 weeks
Drug: L-glutamine
L-glutamine oral powder in 5 gram packet
Also known as: oral L-glutamine
Change from baseline in the number of colonic diverticula via colonoscopy at 6 and 12 months in patients with diverticulosis.
Number of diverticula for both the descending colon and sigmoid will be counted at baseline, at 6 months and at 12 months
Time frame: Baseline, 6 months and 12 months
Change from baseline the size of colonic diverticula via colonoscopy at 6 and 12 months in patients with diverticulosis
Size of diverticula at the descending and sigmoid colon will be estimated as small only, large only, or both small and large, where large is defined as greater than 7 mm in diameter
Time frame: Baseline, 6 month and 12 months
Effect of oral L-glutamine on Hematological Parameters - Hemoglobin
Patient's hemoglobin will be collected at each visit
Time frame: Baseline to 48 weeks (12 months)
Effect of oral L-glutamine on Hematological Parameters - Hematocrit
Patient's hematocrit will be collected at each visit
Time frame: Baseline to 48 weeks (12 months)
Effect of oral L-glutamine on Vital Signs - Blood Pressure
Patient's blood pressure will be collected at each visit
Time frame: Baseline to 48 weeks (12 months)
Effect of oral L-glutamine on Vital Signs - Pulse Rate
Patient's pulse rate will be collected at each visit
Time frame: Baseline to 48 weeks (12 months)
Effect of oral L-glutamine on Vital Signs - Temperature
Patient's temperature will be collected at each visit
Time frame: Baseline to 48 weeks (12 months)
Effect of oral L-glutamine on Vital Signs - Respiration
Patient's respiration will be collected at each visit
Time frame: Baseline to 48 weeks (12 months)
Ran from Jul 2019 to primary completion in Dec 2022, 41 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Glutamine
Emmaus Medical, Inc.