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Amino Acid
L-glutamine Treatment in Patients With Diverticulosis
Phase 1
Waitlist Available
Research Sponsored by Emmaus Medical, Inc.
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 baseline to 48 weeks (12 months)
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Summary
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.
Eligible Conditions
- Diverticulitis
- Diverticulosis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 48 weeks (12 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 48 weeks (12 months)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change from baseline in the number of colonic diverticula via colonoscopy at 6 and 12 months in patients with diverticulosis.
Secondary study objectives
Change from baseline the size of colonic diverticula via colonoscopy at 6 and 12 months in patients with diverticulosis
Effect of oral L-glutamine on Hematological Parameters - Hematocrit
Effect of oral L-glutamine on Hematological Parameters - Hemoglobin
+4 moreSide effects data
From 2014 Phase 3 trial • 230 Patients • NCT0117921781%
Sickle cell anaemia with crisis
25%
Constipation
23%
Nausea
22%
Pyrexia
21%
Headache
18%
Upper respiratory tract infection
17%
Cough
16%
Pain in extremity
15%
Vomiting
14%
Chest pain
13%
Back pain
13%
Arthralgia
12%
Abdominal pain
12%
Acute chest syndrome
11%
Abdominal pain upper
10%
Ocular icterus
9%
Pruritus
8%
Diarrhoea
8%
Acute Chest Syndrome
7%
Nasopharyngitis
7%
Urinary tract infection
7%
Nasal congestion
7%
Oropharnyngeal pain
6%
Fatigue
6%
Pneumonia
6%
Leukocytosis
5%
Anaemia
5%
Tachycardia
5%
Oedema peripheral
5%
Dizziness
5%
Dyspnoea
4%
Hypokalaemia
4%
Hypomanesaemia
3%
Asthma
3%
Bronchitis
3%
Gastroenteritis
3%
Hyperkalaemia
3%
Epistaxis
3%
Hypoxia
2%
Influenza
2%
Rash
1%
Leucocytosis
1%
Cardiac Arrest
1%
Gastritis
1%
Death
1%
Cholelithiasis
1%
Gastrointestinal viral infection
1%
Lobar pneumonia
1%
Osteomyelitis
1%
Pharnygitis streptococcal
1%
Sepsis
1%
Sinustitis
1%
Post-traumatic reaction
1%
Dehydration
1%
Joint effusion
1%
Transient ischaemic attack
1%
Haematuria
1%
Renal failure acute
1%
Bronchial hyperreactivity
1%
Pulmonary embolism
1%
Rhinitis allergic
1%
Skin ulcer
1%
Strabismus correction
1%
Aplastic anaemia
1%
Haemolysis
1%
Hypersplenism
1%
Pain
1%
Cholecystitis
1%
Cholecystitis acute
1%
Complication of device removal
1%
Device malfunction
1%
Fall
1%
Haemolytic transfusion reaction
1%
Pregnancy
1%
Deep vein thrombosis
1%
Thrombophlebits superficial
100%
80%
60%
40%
20%
0%
Study treatment Arm
L-glutamine
100% Maltodextrin
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: L-glutamineExperimental Treatment1 Intervention
Participants received L-glutamine oral powder 15 grams twice daily for 48 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
L-Glutamine
FDA approved
Find a Location
Who is running the clinical trial?
Emmaus Medical, Inc.Lead Sponsor
7 Previous Clinical Trials
373 Total Patients Enrolled
Yutaka L Niihara, MDStudy ChairEmmaus Medical, Inc.