NCT00838149

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2005

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 6, 2009

Completed
Last Updated

February 6, 2009

Status Verified

February 1, 2009

Enrollment Period

2.8 years

First QC Date

February 5, 2009

Last Update Submit

February 5, 2009

Conditions

Crohn's Disease

Outcome Measures

Primary Outcomes (1)

  • Improvement in intestinal permeability after glutamine supplementation

    Baseline and after two months of intervention

Secondary Outcomes (1)

  • Change in small intestinal morphology after glutamine supplementation

    Baseline and after two months of intervention

Study Arms (2)

Glutamine

ACTIVE COMPARATOR

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

Whey Protein

PLACEBO COMPARATOR

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: GlutamineDietary Supplement: Whey protein

Interventions

GlutamineDIETARY_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.

Also known as: L-Glutamine
GlutamineWhey Protein
Whey proteinDIETARY_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.

Also known as: Whey Protein Concentrate
Whey Protein

Eligibility Criteria

Age15 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • All the consecutive patients with Crohn's disease in the remission phase with an abnormal intestinal permeability (IP)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

All India Institute of Medical Sciences

New Delhi, New Delhi, 110029, India

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

GlutamineWhey ProteinsWhey

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, BasicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DiaminoAmino Acids, NeutralMilk ProteinsAnimal Proteins, DietaryDietary ProteinsProteinsMilkDairy ProductsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesBeverages

Study Officials

  • Yogendra K Joshi, M.D., PhD.

    All India Institute of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 5, 2009

First Posted

February 6, 2009

Study Start

November 1, 2005

Primary Completion

August 1, 2008

Study Completion

November 1, 2008

Last Updated

February 6, 2009

Record last verified: 2009-02

Locations

IN(1)