Crohn's DiseasePhase 1NCT00838149
Effect of Glutamine on Intestinal Permeability in Crohn's Disease
A Phase 1 study testing Glutamine and Whey protein in people with Crohn's Disease, run by All India Institute of Medical Sciences at 1 site in India.
Trial summary
The purpose of this study is to see whether enteral glutamine supplementation improves intestinal permeability and small intestinal morphology in patients with Crohn's disease. Read more about this study
- Who is it for?
- Ages 15 to 60 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Glutamine and Whey protein
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteIndia
- Study dates
- Nov 2005to Nov 2008
- 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 15 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- All the consecutive patients with Crohn's disease in the remission phase with an abnormal intestinal permeability (IP)
Who cannot join
- Patients in the active phase of the disease i.e. CDAI score >150
- Patients with a normal intestinal permeability i.e. LMR < 0.0373
- Patients already taking a high protein nutritional supplement
- Patients with other associated systemic diseases like chronic liver disease, chronic kidney disease, diabetes mellitus, malignancy
- Patients with a special physiologic condition i.e., pregnancy or lactation.
- Patients lesser than 15 years (pediatric group) and more than 60 years of age (elderly patients)
Trial locations and contacts
1 site in 1 country.
India1 site
All India Institute of Medical Sciences
New Delhi, New Delhi, 110029
About this study
Official title: Effect of Glutamine Supplementation on the Structure and Function of the Mucosa of Small Intestine in Crohn's Disease: A Randomized Controlled Trial
The purpose of this study is to see whether enteral glutamine supplementation improves intestinal permeability and small intestinal morphology in patients with Crohn's disease.
Read the detailed description
Glutamine is the most abundant amino acid in the body constituting 50% to 60% of total free amino acid pool in muscle and 20% in plasma. Recently it has been reclassified as a conditionally essential amino acid due to body's inability to synthesize sufficient amount under stressful conditions like trauma and sepsis. It is an essential fuel for fibroblasts, lymphocytes and enterocytes. It plays an important role in nitrogen balance and an integral role in glucose regulation and also in acid base homeostasis. It is an essential ingredient for glutathione, an important antioxidant. During the last decade a number of experimental and clinical studies, by using enteral and parenteral glutamine supplements, have shown its beneficial role in conditions like sepsis and infection, elective surgery and accidental injury, catabolic state, fetal and critically ill low birth weight neonates and cancer. A few experimental and clinical studies have also shown its positive role in inflammatory bowel disease, which is attributed to the effect of glutamine on intestinal permeability, growth of enterocytes, enhancement of gut immunity and glutathione synthesis. So far there is hardly any well-planned randomized trial of enteral glutamine supplements in Crohn's disease. Hence this study is planned to evaluate effect of enteral glutamine supplements on structure and function of intestine in patients with Crohn's disease.
Diagnosed cases of Crohn's Disease attending Gastroenterology OPD or admitted in ward at AIIMS will be randomized into two groups, glutamine and whey protein group. The parameters for intestinal function and structure tested will be, permeability, villous height, plasma glutamine and D-xylose absorption at the base line and at the end of the intervention. As per the available data improvement is expected in both structure and function of the intestine, which will be an important contribution in the management of this chronic disease.
- Conditions
- Crohn's Disease
- Being tested
- Glutamine, Whey protein
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlutamineDietary supplement
Also called L-Glutamine
Glutamine group :
Glutamine would be supplemented (0.5gm/Kg ideal body weight) in the form of a water soluble commercial preparation containing 10 gm of pure L- Glutamine in the crystalline form. The patient in this group would be counseled to meet the remaining protein requirement (i.e1g/Kg/wt) by usual diet. This intervention would be made over a period of two months.
Whey proteinDietary supplement
Also called Whey Protein Concentrate
Whey protein group:
Whey protein would be supplemented (0.5gm/Kg ideal body weight) in the form of a water soluble whey protein concentrate containing 70 % protein. The patient in this group would be counseled to meet the remaining protein requirement (i.e1g/Kg/wt) by usual diet. This intervention would be made over a period of two months.
| Study group | Role | What they receive |
|---|---|---|
| Glutamine | Active comparator | Glutamine would be supplemented (0.5gm/Kg ideal body weight) in the form of a water soluble commercial preparation containing 10 gm of pure L- Glutamine in the crystalline form. The patient in this group would be counseled to meet the remaining protein requirement (i.e1g/Kg/wt) by usual diet. This intervention would be made over a period of two months. Receives: Dietary Supplement: Glutamine |
| Whey Protein | Placebo comparator | Whey Protein:
Whey protein would be supplemented (0.5gm/Kg ideal body weight) in the form of a water soluble whey protein concentrate containing 70 % protein. The patient in this group would be counseled to meet the remaining protein requirement (i.e1g/Kg/wt) by usual diet. This intervention would be made over a period of two months. Receives: Dietary Supplement: Glutamine; Dietary Supplement: Whey protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in intestinal permeability after glutamine supplementation
Measured: Baseline and after two months of intervention
Secondary outcomes (1)
Change in small intestinal morphology after glutamine supplementation
Measured: Baseline and after two months of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2009 (estimated)
- Study startNov 2005
- Primary completionAug 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Yogendra K Joshi, M.D., PhD., Principal investigator, All India Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00838149
- Sponsor's protocol ID
- I458
- Status last verified
- Feb 2009
- First submitted
- 5 Feb 2009
- Last updated
- 6 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Glutamine Supplementation on the Structure and Function of the Mucosa of Small Intestine in Crohn's Disease: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00838149
- Acronym / sponsor ID
- I458
- Conditions
- Crohn's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Study start
- Nov 2005
- Primary completion
- Aug 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 6 Feb 2009 (estimated)
- 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 this study is to see whether enteral glutamine supplementation improves intestinal permeability and small intestinal morphology in patients with Crohn's disease.
Detailed description
Glutamine is the most abundant amino acid in the body constituting 50% to 60% of total free amino acid pool in muscle and 20% in plasma. Recently it has been reclassified as a conditionally essential amino acid due to body's inability to synthesize sufficient amount under stressful conditions like trauma and sepsis. It is an essential fuel for fibroblasts, lymphocytes and enterocytes. It plays an important role in nitrogen balance and an integral role in glucose regulation and also in acid base homeostasis. It is an essential ingredient for glutathione, an important antioxidant. During the last decade a number of experimental and clinical studies, by using enteral and parenteral glutamine supplements, have shown its beneficial role in conditions like sepsis and infection, elective surgery and accidental injury, catabolic state, fetal and critically ill low birth weight neonates and cancer. A few experimental and clinical studies have also shown its positive role in inflammatory bowel disease, which is attributed to the effect of glutamine on intestinal permeability, growth of enterocytes, enhancement of gut immunity and glutathione synthesis. So far there is hardly any well-planned randomized trial of enteral glutamine supplements in Crohn's disease. Hence this study is planned to evaluate effect of enteral glutamine supplements on structure and function of intestine in patients with Crohn's disease.
Diagnosed cases of Crohn's Disease attending Gastroenterology OPD or admitted in ward at AIIMS will be randomized into two groups, glutamine and whey protein group. The parameters for intestinal function and structure tested will be, permeability, villous height, plasma glutamine and D-xylose absorption at the base line and at the end of the intervention. As per the available data improvement is expected in both structure and function of the intestine, which will be an important contribution in the management of this chronic disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glutamine | Active comparator | Dietary Supplement: GlutamineGlutamine would be supplemented (0.5gm/Kg ideal body weight) in the form of a water soluble commercial preparation containing 10 gm of pure L- Glutamine in the crystalline form. The patient in this group would be counseled to meet the remaining protein requirement (i.e1g/Kg/wt) by usual diet. This intervention would be made over a period of two months. |
| Whey Protein | Placebo comparator | Dietary Supplement: Glutamine, Dietary Supplement: Whey proteinWhey Protein: Whey protein would be supplemented (0.5gm/Kg ideal body weight) in the form of a water soluble whey protein concentrate containing 70 % protein. The patient in this group would be counseled to meet the remaining protein requirement (i.e1g/Kg/wt) by usual diet. This intervention would be made over a period of two months. |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- All the consecutive patients with Crohn's disease in the remission phase with an abnormal intestinal permeability (IP)
Key exclusion criteria (6 listed)
- Patients in the active phase of the disease i.e. CDAI score >150
- Patients with a normal intestinal permeability i.e. LMR < 0.0373
- Patients already taking a high protein nutritional supplement
- Patients with other associated systemic diseases like chronic liver disease, chronic kidney disease, diabetes mellitus, malignancy
- Patients with a special physiologic condition i.e., pregnancy or lactation.
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 |
|---|---|---|
| GlutamineAlso: L-GlutamineGlutamine group : Glutamine would be supplemented (0.5gm/Kg ideal body weight) in the form of a water soluble commercial preparation containing 10 gm of pure L- Glutamine in the crystalline form. The patient in this group would be counseled to meet the remaining protein requirement (i.e1g/Kg/wt) by usual diet. This intervention would be made over a period of two months. | Dietary supplement | Glutamine, Whey Protein |
| Whey proteinAlso: Whey Protein ConcentrateWhey protein group: Whey protein would be supplemented (0.5gm/Kg ideal body weight) in the form of a water soluble whey protein concentrate containing 70 % protein. The patient in this group would be counseled to meet the remaining protein requirement (i.e1g/Kg/wt) by usual diet. This intervention would be made over a period of two months. | Dietary supplement | Whey Protein |
Primary outcome
Improvement in intestinal permeability after glutamine supplementation
Time frame: Baseline and after two months of intervention
1 secondary outcome
Change in small intestinal morphology after glutamine supplementation
Time frame: Baseline and after two months of intervention
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 6 Feb 2009.
Related trials for Crohn's Disease
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
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.
Yogendra K Joshi, M.D., PhD. principal investigator
All India Institute of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Glutamine and Whey protein in people with Crohn's Disease, run by All India Institute of Medical Sciences at 1 site in India.
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 1 inclusion and 6 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 6 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. 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. Some participants in this study may receive a placebo. 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?
Improvement in intestinal permeability after glutamine supplementation (time frame: Baseline and after two months of intervention). 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 6 Feb 2009.