Diverticulosis, ColonicPhase 1NCT05106101
L-glutamine Treatment in Patients With Diverticulosis
A Phase 1 study testing L-glutamine in people with Diverticulosis, Colonic, run by Emmaus Medical, Inc. at 3 sites in United States.
Trial summary
The purpose of the study is evaluate the safety and efficacy of L-glutamine as a treatment for patients with diverticulosis. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Diverticulosis, Colonic
- What is being tested?
- L-glutamine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 3 sitesUnited States
- Study dates
- 19 Jul 2019to 30 Dec 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥50 years of age.
- Uncomplicated diverticulosis confirmed by colonoscopy.
- Colonoscopy indicates ≥5 colonic diverticula (pouches) in the descending/sigmoid colon and < approximately10 colonic diverticula (pouches) per segment (e.g. proximal descending, distal descending, proximal sigmoid, and distal sigmoid.)
- If the patient is a female of child-bearing potential, she agrees to avoid pregnancy during the study and is willing and agrees to practice a recognized form of birth control during the course of the study (e.g., barrier, birth control pills, or abstinence).
- Patients who have given their free and written informed consent.
Who cannot join
- Acute diverticulitis (both complicated and uncomplicated).
- Acute colitis
- History of inflammatory bowel disease, colon resection, polyposis syndrome, severe strictures, and perforation.
- Active bleeding
- More than 40 diverticula
- Chronic renal insufficiency
Show all 15Show fewer
- Chronic liver disease.
- Patient is pregnant or lactating or has the intention of becoming pregnant during the study (if female of childbearing potential).
- Inability to give a valid informed consent or to properly follow the protocol.
- Patients with an active malignancy of any type, or a recent history of malignancy within the last 5 years.
- Treated with an investigational medication/treatment within 30 days prior to the screening visit.
- Currently enrolled in an Investigational study
- Patient is currently taking or has been treated with any form of glutamine supplement within 30 days of the screening visit.
- Previous difficulty pulling or passing of scope or difficulty completing colonoscopy.
- There are factors that would, in the judgment of the investigator, make it difficult for the patient to comply with the requirements of the study.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229
The Lundquist Institute at Harbor-UCLA Medical Center
Torrance, California, 90502
Ventura Clinical Trials
Ventura, California, 93003
About this study
Official title: A Pilot/Phase 1, Interventional, Open-label, Multi-center Study to Assess the Safety and Efficacy of L-glutamine Treatment in Patients With Diverticulosis
The purpose of the study is evaluate the safety and efficacy of L-glutamine as a treatment for patients with diverticulosis.
Read the detailed description
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)
- Conditions
- Diverticulosis, Colonic
- Being tested
- L-glutamine
- Medical subject headings
- Diverticulosis, Colonic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-glutamineDrug
Also called oral L-glutamine
L-glutamine oral powder in 5 gram packet
| Study group | Role | What they receive |
|---|---|---|
| L-glutamine | Experimental | Participants received L-glutamine oral powder 15 grams twice daily for 48 weeks Receives: Drug: L-glutamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, 6 months and 12 months
Secondary outcomes (7)
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
Measured: Baseline, 6 month and 12 months
Effect of oral L-glutamine on Hematological Parameters - Hemoglobin
Patient's hemoglobin will be collected at each visit
Measured: Baseline to 48 weeks (12 months)
Effect of oral L-glutamine on Hematological Parameters - Hematocrit
Patient's hematocrit will be collected at each visit
Measured: 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
Measured: 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
Measured: Baseline to 48 weeks (12 months)
Effect of oral L-glutamine on Vital Signs - Temperature
Patient's temperature will be collected at each visit
Measured: Baseline to 48 weeks (12 months)
Effect of oral L-glutamine on Vital Signs - Respiration
Patient's respiration will be collected at each visit
Measured: Baseline to 48 weeks (12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start19 Jul 2019
- Primary completion30 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diverticulosis, ColonicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emmaus Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yutaka L Niihara, MD, Study chair, Emmaus Medical, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05106101
- Sponsor's protocol ID
- EM-DsD-002
- Status last verified
- Nov 2022
- First submitted
- 22 Sep 2021
- Last updated
- 16 Feb 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot/Phase 1, Interventional, Open-label, Multi-center Study to Assess the Safety and Efficacy of L-glutamine Treatment in Patients With Diverticulosis
- ClinicalTrials.gov ID
- NCT05106101
- Acronym / sponsor ID
- EM-DsD-002
- Conditions
- Diverticulosis, Colonic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Emmaus Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Jul 2019 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 3 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is evaluate the safety and efficacy of L-glutamine as a treatment for patients with diverticulosis.
Detailed description
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| L-glutamine | Experimental | Drug: L-glutamineParticipants received L-glutamine oral powder 15 grams twice daily for 48 weeks |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥50 years of age.
- Uncomplicated diverticulosis confirmed by colonoscopy.
- Colonoscopy indicates ≥5 colonic diverticula (pouches) in the descending/sigmoid colon and < approximately10 colonic diverticula (pouches) per segment (e.g. proximal descending, distal descending, proximal sigmoid, and distal sigmoid.)
- If the patient is a female of child-bearing potential, she agrees to avoid pregnancy during the study and is willing and agrees to practice a recognized form of birth control during the course of the study (e.g., barrier, birth control pills, or abstinence).
- Patients who have given their free and written informed consent.
Key exclusion criteria (15 listed)
- Acute diverticulitis (both complicated and uncomplicated).
- Acute colitis
- History of inflammatory bowel disease, colon resection, polyposis syndrome, severe strictures, and perforation.
- Active bleeding
- More than 40 diverticula
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L-glutamineAlso: oral L-glutamineL-glutamine oral powder in 5 gram packet | Drug | L-glutamine |
Primary outcome
Change from baseline in the number of colonic diverticula via colonoscopy at 6 and 12 months in patients with diverticulosis.
Time frame: Baseline, 6 months and 12 months
Number of diverticula for both the descending colon and sigmoid will be counted at baseline, at 6 months and at 12 months
7 secondary outcomes
Change from baseline the size of colonic diverticula via colonoscopy at 6 and 12 months in patients with diverticulosis
Time frame: Baseline, 6 month and 12 months
Effect of oral L-glutamine on Hematological Parameters - Hemoglobin
Time frame: Baseline to 48 weeks (12 months)
Effect of oral L-glutamine on Hematological Parameters - Hematocrit
Time frame: Baseline to 48 weeks (12 months)
Effect of oral L-glutamine on Vital Signs - Blood Pressure
Time frame: Baseline to 48 weeks (12 months)
Effect of oral L-glutamine on Vital Signs - Pulse Rate
Time frame: Baseline to 48 weeks (12 months)
Effect of oral L-glutamine on Vital Signs - Temperature
Time frame: Baseline to 48 weeks (12 months)
Effect of oral L-glutamine on Vital Signs - Respiration
Time frame: Baseline to 48 weeks (12 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yutaka L Niihara, MD study chair
Emmaus Medical, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing L-glutamine in people with Diverticulosis, Colonic, run by Emmaus Medical, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the number of colonic diverticula via colonoscopy at 6 and 12 months in patients with diverticulosis. (time frame: Baseline, 6 months and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2023; AzTrials last refreshed its copy on 7 Nov 2026.