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Effect of Glutamine on Intestinal Permeability in Crohn's Disease

Primary Purpose

Crohn's Disease

Status
Completed
Phase
Phase 1
Locations
India
Study Type
Interventional
Intervention
Glutamine
Whey protein
Sponsored by
All India Institute of Medical Sciences, New Delhi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease

Eligibility Criteria

15 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All the consecutive patients with Crohn's disease in the remission phase with an abnormal intestinal permeability (IP)

Exclusion Criteria:

  • 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)

Sites / Locations

  • All India Institute of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Glutamine

Whey Protein

Arm Description

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 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.

Outcomes

Primary Outcome Measures

Improvement in intestinal permeability after glutamine supplementation

Secondary Outcome Measures

Change in small intestinal morphology after glutamine supplementation

Full Information

First Posted
February 5, 2009
Last Updated
February 5, 2009
Sponsor
All India Institute of Medical Sciences, New Delhi
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1. Study Identification

Unique Protocol Identification Number
NCT00838149
Brief Title
Effect of Glutamine on Intestinal Permeability in Crohn's Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
All India Institute of Medical Sciences, New Delhi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Glutamine
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Whey Protein
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Glutamine
Other Intervention Name(s)
L-Glutamine
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Whey protein
Other Intervention Name(s)
Whey Protein Concentrate
Intervention Description
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.
Primary Outcome Measure Information:
Title
Improvement in intestinal permeability after glutamine supplementation
Time Frame
Baseline and after two months of intervention
Secondary Outcome Measure Information:
Title
Change in small intestinal morphology after glutamine supplementation
Time Frame
Baseline and after two months of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All the consecutive patients with Crohn's disease in the remission phase with an abnormal intestinal permeability (IP) Exclusion Criteria: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yogendra K Joshi, M.D., PhD.
Organizational Affiliation
All India Institute of Medical Sciences, New Delhi
Official's Role
Principal Investigator
Facility Information:
Facility Name
All India Institute of Medical Sciences
City
New Delhi
ZIP/Postal Code
110029
Country
India

12. IPD Sharing Statement

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Effect of Glutamine on Intestinal Permeability in Crohn's Disease

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