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Completed

NCT Number: NCT01841099

Mesalamine in Environmental Enteropathy

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.

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Key information

Conditions

Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

1 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Baraka Clinic

Nairobi, Mathare, Kenya

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Mesalamine

Drug

Mesalamine granules

Other names: Mesalazine, Pentasa (trade name)

Placebo granules

Drug

Provided by Ferring Pharma

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Kelsey Jones

Other

Collaborators

  • Imperial College London

Registry information

Official study title

Randomised Placebo-controlled Trial of a Gut Immunomodulatory Agent (Mesalamine) to Tackle Environmental Enteropathy in Acutely Malnourished Children: A Pilot Study.

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 26, 2013
Registry last updated
Jul 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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