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MalnutritionPhase 3IMAGINENCT01832636

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

A Phase 3 study testing Alanyl-Glutamine in people with Malnutrition and Environmental Enteropathy, run by Children's Hospital Medical Center, Cincinnati at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 2 months to 5 years
Conditions the study is for
Malnutrition, Environmental Enteropathy, Diarrhea
What is being tested?
Alanyl-Glutamine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
112 participants
Where
1 siteBrazil
Study dates
Oct 2013to Dec 2015
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 months to 5 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Universidade Federal do Ceara

    Fortaleza, Ceará

Other trials in Brazil

About this study

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

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?

Being tested
Alanyl-Glutamine
Keywords
L-Alanyl-L-Glutamine, Environmental enteric dysfunction, Tropical enteropathy
Medical subject headings
Malnutrition, Diarrhea, Sprue, Tropical

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Alanyl-GlutamineDietary supplement

    Also called AminoStable (Ajinomoto)

    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.

Study groups in NCT01832636
Study groupRoleWhat they receive
Alanyl-Glutamine 3g/dActive comparatorAlanyl-Glutamine orally 3g/day for 10 days
Receives: Dietary Supplement: Alanyl-Glutamine
Alanyl-Glutamine 6g/dActive comparatorAlanyl-Glutamine orally 6g/day for 10 days
Receives: Dietary Supplement: Alanyl-Glutamine
Alanyl-Glutamine 12g/dActive comparatorAlanyl-Glutamine orally 12g/d for 10 days
Receives: Dietary Supplement: Alanyl-Glutamine
Glycine 12.5g/dPlacebo comparatorGlycine orally 12.5 g/d for 10 days. This dose is calculated to be isonitrogenous to 12g of Alanyl-Glutamine.
Receives: Dietary Supplement: Alanyl-Glutamine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Urine Collection on Day 1, 10-13, 30-37

Secondary outcomes (6)

  1. Fecal Lactoferrin Test

    To evaluate the effect of time and dose-response of alanyl-glutamine on intestinal inflammation, as measured by qualitative or quantitative testing for fecal lactoferrin in stools of children at risk of undernutrition.

    Measured: Fecal sample collected on Day 1, 10-13, 30-37

  2. Fecal Cytokine Measurement

    To evaluate the effect of alanyl-glutamine on intestinal inflammation, by measuring proinflammatory cytokines interleukin-1, interleukin-8, tumor necrosis factor-alpha (TNF), and regenerating gene 1B (REG1B) in stools of children at risk of undernutrition.

    Measured: Fecal sample collected on Day 1, 10-13

  3. Anthropometry

    To evaluate the time and dose-effect of alanyl-glutamine on short and medium-term nutritional status by evaluating changes in anthropometric measures (z scores) over time: height-for-age, weight-for-age, and weight-for-height.

    Measured: Measured and calculated Day 1, 10-13, 30-37, 90-104, 120-141

  4. Fecal Calorimetry

    To evaluate the effect of time and dose-response of alanyl-glutamine on the intestinal absorption of fat, protein, and carbohydrates, by measurement of fecal energy content by bomb calorimetry.

    Measured: Fecal sample collected on Day 1, 10-13, 30-37

  5. Metabolomic Profile of Urine

    To evaluate the time and dose-effect of alanyl-glutamine on metabolism in children at risk of undernutrition by means of urine metabolomic profile tests.

    Measured: Collected on Day 1, 10-13, 30-37

  6. History of Diarrhea in the Previous Two Weeks

    History of diarrhea in the previous two weeks. A day of diarrhea will be defined as 3 or more looser than normal bowel movements in a 24-hour period. Distinct episodes must be separated by at least 2 days without diarrhea. Duration of episodes will be classified as acute (< 7 days), prolonged acute (>6 and <14 days), or persistent (>13 days).

    Measured: Day 1, 30-37, 90-104, 120-141

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Apr 2013 (estimated)
  2. Study startOct 2013
  3. Primary completionDec 2015
  4. Study completionDec 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
112 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01832636
Sponsor's protocol ID
CIN001 -"IMAGINE"
Acronym
IMAGINE
Status last verified
Jul 2016
First submitted
12 Apr 2013
Last updated
1 Aug 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 17325559

  • Moore 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.

    PubMed 32826717

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Alanyl-Glutamine in people with Malnutrition and Environmental Enteropathy, run by Children's Hospital Medical Center, Cincinnati at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Urinary Lactulose: Mannitol Intestinal Permeability Test (time frame: Urine Collection on Day 1, 10-13, 30-37). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01832636, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2016.

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