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Completed

NCT Number: NCT00838149

Effect of Glutamine on Intestinal Permeability in Crohn's Disease

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.

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Key information

Age range

15 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

All India Institute of Medical Sciences

New Delhi, 110029, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Glutamine

Dietary Supplement

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

Whey Protein

Dietary Supplement

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

Primary outcomes

  1. Improvement in intestinal permeability after glutamine supplementation

    Time frame: Baseline and after two months of intervention

Secondary outcomes

  1. Change in small intestinal morphology after glutamine supplementation

    Time frame: Baseline and after two months of intervention

Sponsors and collaborators

Lead sponsor

All India Institute of Medical Sciences

Other

Registry information

Official study title

Effect of Glutamine Supplementation on the Structure and Function of the Mucosa of Small Intestine in Crohn's Disease: A Randomized Controlled Trial

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Feb 6, 2009
Registry last updated
Feb 6, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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