Intervention and Mechanisms of Alanyl-Glutamine for Inflammation, Nutrition, and Enteropathy (IMAGINE)

Cincinnati Children's Hospital Medical Center

Status and phase: Completed; Phase 3

Conditions: Diarrhea; Malnutrition; Environmental Enteropathy

Treatments: Dietary Supplement: Alanyl-Glutamine

Study type: Interventional

Funder types: Other

Identifiers

NCT01832636

CIN001 -"IMAGINE"

Details and patient eligibility

About

Several host factors underlie the pathogenesis of the reciprocal cycle of childhood diarrhea and undernutrition in developing countries. These include intestinal inflammation, mucosal damage, and alterations in intestinal barrier function that lead to malabsorption, growth failure, and heightened susceptibility to recurrent and prolonged episodes of diarrhea. Recent studies from Northeast Brazil demonstrate the benefits of a novel alanyl-glutamine-based oral rehydration and nutrition therapy (Ala-Gln ORNT) in speeding the recovery of damaged intestinal barrier function in cell culture, animal models, patients with AIDS, and underweight children.

Oral supplementation with Alanyl-Glutamine (Ala-Gln; 24g a day for 10 days) improves short-term gut integrity and weight velocity 4 months after therapy in a group of undernourished children from Northeast Brazil. Intervention and Mechanisms of Alanyl-Glutamine for Inflammation, Nutrition, and Enteropathy (IMAGINE) is a study designed to answer the following questions: 1) What is the lowest dose of Ala-Gln that improves intestinal barrier function, intestinal inflammation, and nutritional status in children at risk of underweight, wasting, or stunting? 2) What are the mechanisms by which Ala-Gln exerts these benefits?

Enrollment: 112 patients

Sex: All

Ages: 2 months to 5 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Children who are undernourished or at risk of undernutrition, with anthropometric z-scores less than or equal to -1 for one of these parameters: height-for-age, weight-for-age, or weight-for-height.
2. Children ages 2 months to 5 years old.

Exclusion criteria

1. Children who are exclusively breastfed.
2. Have participated in another intervention study in the past two years.
3. Fever greater than 38.8 ° C.
4. Use of antibiotics.
5. Systemic disease or other serious medical condition (including, but not limited to meningitis, pneumonia, tuberculosis, and chickenpox).
6. Children who are unable to ingest, retain or absorb nutritional supplements.
7. Children whose families plan to move from the study area within the next 6 months.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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112 participants in 4 patient groups, including a placebo group

Alanyl-Glutamine 3g/d

Active Comparator group

Description:

Alanyl-Glutamine orally 3g/day for 10 days

Treatment:

Dietary Supplement: Alanyl-Glutamine

Alanyl-Glutamine 6g/d

Active Comparator group

Description:

Alanyl-Glutamine orally 6g/day for 10 days

Treatment:

Dietary Supplement: Alanyl-Glutamine

Alanyl-Glutamine 12g/d

Active Comparator group

Description:

Alanyl-Glutamine orally 12g/d for 10 days

Treatment:

Dietary Supplement: Alanyl-Glutamine

Glycine 12.5g/d

Placebo Comparator group

Description:

Glycine orally 12.5 g/d for 10 days. This dose is calculated to be isonitrogenous to 12g of Alanyl-Glutamine.

Treatment:

Dietary Supplement: Alanyl-Glutamine