Mesalamine in Environmental Enteropathy

Kelsey Jones

Status and phase

Completed

Phase 2

Phase 1

Conditions

Malnutrition

Treatments

Drug: Placebo granules

Drug: Mesalamine

Study type

Interventional

Funder types

Other

Identifiers

NCT01841099

KEMRI_CT_2013/0016

SSC 2223 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

44 patients

Sex

All

Ages

1 to 5 years old

Volunteers

No Healthy Volunteers

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).