Intervention and Mechanisms of Alanyl-Glutamine for Inflammation, Nutrition, and Enteropathy
IMAGINE
1 other identifier
interventional
112
1 country
1
Brief Summary
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?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 12, 2013
CompletedFirst Posted
Study publicly available on registry
April 16, 2013
CompletedStudy Start
First participant enrolled
October 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedAugust 1, 2016
July 1, 2016
2.2 years
April 12, 2013
July 28, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Urinary Lactulose: Mannitol Intestinal Permeability Test
Determine the dose-and time-effect of alanyl-glutamine on intestinal barrier function recovery using the intestinal permeability test, with measurement of the percentage of urinary excretion of lactulose, mannitol and ratio of lactulose:mannitol.
Urine Collection on Day 1, 10-13, 30-37
Secondary Outcomes (6)
Fecal Lactoferrin Test
Fecal sample collected on Day 1, 10-13, 30-37
Fecal Cytokine Measurement
Fecal sample collected on Day 1, 10-13
Anthropometry
Measured and calculated Day 1, 10-13, 30-37, 90-104, 120-141
Fecal Calorimetry
Fecal sample collected on Day 1, 10-13, 30-37
Metabolomic Profile of Urine
Collected on Day 1, 10-13, 30-37
- +1 more secondary outcomes
Study Arms (4)
Alanyl-Glutamine 3g/d
ACTIVE COMPARATORAlanyl-Glutamine orally 3g/day for 10 days
Alanyl-Glutamine 6g/d
ACTIVE COMPARATORAlanyl-Glutamine orally 6g/day for 10 days
Alanyl-Glutamine 12g/d
ACTIVE COMPARATORAlanyl-Glutamine orally 12g/d for 10 days
Glycine 12.5g/d
PLACEBO COMPARATORGlycine orally 12.5 g/d for 10 days. This dose is calculated to be isonitrogenous to 12g of Alanyl-Glutamine.
Interventions
Alanyl-Glutamine and Glycine doses will be prepared immediately prior to administration by dissolving in formula, milk, or fruit juice. Administration of each dose will be directly observed by a study nurse or health agent.
Eligibility Criteria
You may qualify if:
- 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.
- Children ages 2 months to 5 years old.
You may not qualify if:
- Children who are exclusively breastfed.
- Have participated in another intervention study in the past two years.
- Fever greater than 38.8 ° C.
- Use of antibiotics.
- Systemic disease or other serious medical condition (including, but not limited to meningitis, pneumonia, tuberculosis, and chickenpox).
- Children who are unable to ingest, retain or absorb nutritional supplements.
- Children whose families plan to move from the study area within the next 6 months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universidade Federal do Ceara
Fortaleza, Ceará, Brazil
Related Publications (2)
Lima NL, Soares AM, Mota RM, Monteiro HS, Guerrant RL, Lima AA. Wasting and intestinal barrier function in children taking alanyl-glutamine-supplemented enteral formula. J Pediatr Gastroenterol Nutr. 2007 Mar;44(3):365-74. doi: 10.1097/MPG.0b013e31802eecdd.
PMID: 17325559BACKGROUNDMoore SR, Quinn LA, Maier EA, Guedes MM, Quetz JS, Perry M, Ramprasad C, Lanzarini Lopes GML, Mayneris-Perxachs J, Swann J, Soares AM, Filho JQ, Junior FS, Havt A, Lima NL, Guerrant RL, Lima AAM. Intervention and Mechanisms of Alanyl-glutamine for Inflammation, Nutrition, and Enteropathy: A Randomized Controlled Trial. J Pediatr Gastroenterol Nutr. 2020 Sep;71(3):393-400. doi: 10.1097/MPG.0000000000002834.
PMID: 32826717DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sean R Moore, MD, MS
Cincinnati Children´s Hospital
- PRINCIPAL INVESTIGATOR
Aldo Lima, MD, PhD
Universidade Federal do Ceara
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 12, 2013
First Posted
April 16, 2013
Study Start
October 1, 2013
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
August 1, 2016
Record last verified: 2016-07