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Mesalamine in Environmental Enteropathy

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ClinicalTrials.gov Identifier: NCT01841099
Recruitment Status : Completed
First Posted : April 26, 2013
Last Update Posted : July 11, 2014
Sponsor:
Collaborator:
Imperial College London
Information provided by (Responsible Party):
Kelsey Jones, KEMRI-Wellcome Trust Collaborative Research Program

Brief Summary:

Undernutrition is one of the most important health issues in Kenya. Children who are chronically undernourished do not reach their full potential and are at increased risk of infectious disease. Stunting occurs in a third of Kenyan children and has severe and long-term consequences in terms of health, development, and poverty. Several studies have shown that stunting is frequently associated with subclinical inflammation of the bowel, a condition referred to as Environmental Enteropathy (EE), previously known as 'tropical sprue' or 'tropical enteropathy'. EE is clinically similar to childhood inflammatory bowel diseases (IBD), including Crohn's disease. The treatment of IBD routinely involves provision of gut immunomodulatory agents, but this approach has never been tried in EE.

This proposal outlines a pilot double-blind randomised placebo-controlled trial of mesalamine (also called mesalazine - the safest immunomodulator used in IBD with least systemic activity) in treatment of severely malnourished children with EE.


Condition or disease Intervention/treatment Phase
Malnutrition Drug: Mesalamine Drug: Placebo granules Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Randomised Placebo-controlled Trial of a Gut Immunomodulatory Agent (Mesalamine) to Tackle Environmental Enteropathy in Acutely Malnourished Children: A Pilot Study.
Study Start Date : June 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition

Arm Intervention/treatment
Experimental: Mesalamine
Mesalamine. Mesalamine granules. 30 mg/kg/day oral for 7 days followed by 50 mg/kg/day oral for 21 days if tolerated.
Drug: Mesalamine
Mesalamine granules
Other Name: Mesalazine, Pentasa (trade name)

Placebo Comparator: Placebo granules
Placebo granules
Drug: Placebo granules
Provided by Ferring Pharma




Primary Outcome Measures :
  1. Frequency of adverse events/serious adverse events [ Time Frame: Day 0 to day 28 and day 0 to day 56 ]
    This trial represents the first time a member of a class of drugs are to be used in a particular vulnerable group patient group. It's primary purpose is to conduct an early evaluation of safety and acceptability in this and the study is not powered to address any specific outcomes. It represents a modified Phase IIa design

  2. Compliance with treatment [ Time Frame: Day 0 to day 28 ]
    This trial represents the first time a member of a class of drugs are to be used in a particular vulnerable group patient group. It's primary purpose is to conduct an early evaluation of safety and acceptability in this and the study is not powered to address any specific outcomes. It represents a modified Phase IIa design


Secondary Outcome Measures :
  1. Changes in height [ Time Frame: Day 0 to 28 and day 0 to day 56 ]
    mm/day

  2. Changes in levels of anti-Endotoxin Core IgG (EndoCAb) [ Time Frame: Day 0 - Day 28 and Day 0 - Day 56 ]
  3. Changes in fecal calprotectin levels [ Time Frame: Day 0 - Day 28 and Day 0 - Day 56 ]
  4. Changes in plasma soluble-CD14 [ Time Frame: Day 0 - Day 28 and Day 0 - Day 56 ]
  5. Changes in plasma beta-2 microglobulin [ Time Frame: Day 0 - Day 28 and Day 0 - Day 56 ]
  6. Changes in plasma neopterin [ Time Frame: Day 0 - Day 28 and Day 0 - Day 56 ]
  7. Changes in weight [ Time Frame: Day 0 - Day 28 and Day 0 - Day 56 ]
    g/kg/day

  8. Changes in mid-upper arm circumference [ Time Frame: Day 0 - Day 28 and Day 0 - Day 56 ]
    mm/day

  9. Changes in C-Reactive Protein [ Time Frame: Day 0 - Day 28, and Day 0 - Day56 ]


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Ages Eligible for Study:   1 Year to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children aged 1 to 5 years old.
  • Provision of informed consent by parent or guardian.
  • Stunting (height for age z score <-2)
  • Severe malnutrition (one or more of mid-upper arm circumference <11.5cm, weight for height z score <-3, or nutritional oedema).
  • Eligible for outpatient management of malnutrition (i.e. no evidence of acute infection, and passes 'appetite test' according to national guidelines).
  • Evidence of chronic inflammation (elevated erythrocyte sedimentation rate, ESR >20mm/hr).

Exclusion Criteria:

  • Known HIV disease or tuberculosis.
  • Known previous renal disease or asthma.
  • Known allergy or hypersensitivity to mesalamine, other salicylate drugs, or any of the product ingredients.
  • Biochemical evidence of acute renal or hepatic impairment on screening blood tests.
  • Thrombocytopenia
  • Recent (previous two weeks) bloody diarrhoea.
  • Concurrent medication known to interact with the study drug (non-steroidal anti-inflammatory drugs, ranitidine, proton-pump inhibitors)
  • Acute infection requiring treatment, e.g. lower respiratory tract infection or febrile illness.
  • Other reason at the discretion of the attending clinician (independent of the trial team).

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): NCT01841099


Locations
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Kenya
Baraka Clinic
Nairobi, Mathare, Kenya
Sponsors and Collaborators
Kelsey Jones
Imperial College London
Investigators
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Principal Investigator: Kelsey DJ Jones, MBBS BA MRCPCH KEMRI-Wellcome Trust Research Programme and Imperial College London

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kelsey Jones, Study Principal Investigator, KEMRI-Wellcome Trust Collaborative Research Program
ClinicalTrials.gov Identifier: NCT01841099     History of Changes
Other Study ID Numbers: KEMRI_CT_2013/0016
SSC 2223 ( Other Identifier: KEMRI Scientific Steering Committee )
First Posted: April 26, 2013    Key Record Dates
Last Update Posted: July 11, 2014
Last Verified: July 2014
Additional relevant MeSH terms:
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Malnutrition
Nutrition Disorders
Mesalamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents