Crohn's Disease Clinical Trial
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.
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.
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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