We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

Effect of Glutamine on Intestinal Permeability in Crohn's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00838149
Recruitment Status : Completed
First Posted : February 6, 2009
Last Update Posted : February 6, 2009
Sponsor:
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Crohn's Disease Dietary Supplement: Glutamine Dietary Supplement: Whey protein Phase 1

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : November 2005
Primary Completion Date : August 2008
Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
Drug Information available for: Glutamine
U.S. FDA Resources

Arms and Interventions

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 Name: 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 Name: 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 Name: Whey Protein Concentrate


Outcome Measures

Primary Outcome Measures :
  1. Improvement in intestinal permeability after glutamine supplementation [ Time Frame: Baseline and after two months of intervention ]

Secondary Outcome Measures :
  1. Change in small intestinal morphology after glutamine supplementation [ Time Frame: Baseline and after two months of intervention ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   15 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00838149


Locations
India
All India Institute of Medical Sciences
New Delhi, India, 110029
Sponsors and Collaborators
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
More Information

Responsible Party: Prof. Y K Joshi, All India Institute of Medical Sciences
ClinicalTrials.gov Identifier: NCT00838149     History of Changes
Other Study ID Numbers: I458
First Posted: February 6, 2009    Key Record Dates
Last Update Posted: February 6, 2009
Last Verified: February 2009

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases