Effect of Glutamine on Intestinal Permeability in Crohn's Disease

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.

Study Overview

• Status: Completed
• Conditions: Crohn's Disease
• Intervention / Treatment: Dietary supplement: Glutamine; Dietary supplement: Whey protein

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• India
  • New Delhi, India, 110029
    • All India Institute of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Glutamine; 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; 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.; Other Names: L-Glutamine
Placebo Comparator: Whey Protein; 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.	Dietary supplement: 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.; Other Names: L-Glutamine; Dietary supplement: Whey protein; 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.; Other Names: Whey Protein Concentrate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Improvement in intestinal permeability after glutamine supplementation	Baseline and after two months of intervention

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in small intestinal morphology after glutamine supplementation	Baseline and after two months of intervention

Collaborators and Investigators

• Sponsor: All India Institute of Medical Sciences, New Delhi
• Investigators: Principal Investigator: Yogendra K Joshi, M.D., PhD., All India Institute of Medical Sciences, New Delhi

Study record dates

Study Major Dates

• Study Start: November 1, 2005
• Primary Completion (Actual): August 1, 2008
• Study Completion (Actual): November 1, 2008

Study Registration Dates

• First Submitted: February 5, 2009
• First Submitted That Met QC Criteria: February 5, 2009
• First Posted (Estimate): February 6, 2009

Study Record Updates

• Last Update Posted (Estimate): February 6, 2009
• Last Update Submitted That Met QC Criteria: February 5, 2009
• Last Verified: February 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: I458