Effect of Glutamine on Intestinal Permeability in Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 1

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.
    

Intervention name(s): Glutamine; Whey protein
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 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 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 intervention name(s): L-Glutamine; Whey Protein Concentrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment