Mesalamine in Environmental Enteropathy

NCT ID: NCT01841099

Last Updated: 2014-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2014-05-31

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.

Conditions

Malnutrition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Mesalamine

Mesalamine. Mesalamine granules. 30 mg/kg/day oral for 7 days followed by 50 mg/kg/day oral for 21 days if tolerated.

Group Type: EXPERIMENTAL

Mesalamine

Intervention Type: DRUG

Mesalamine granules

Placebo granules

Placebo granules

Group Type: PLACEBO_COMPARATOR

Placebo granules

Intervention Type: DRUG

Provided by Ferring Pharma

Interventions

Mesalamine

Mesalamine granules

Intervention Type: DRUG

Placebo granules

Provided by Ferring Pharma

Intervention Type: DRUG

Other Intervention Names

Mesalazine, Pentasa (trade name)

Eligibility 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).

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Imperial College London

OTHER

Sponsor Role: collaborator

Kelsey Jones

OTHER

Sponsor Role: lead

Responsible Party

Kelsey Jones

Study Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Kelsey DJ Jones, MBBS BA MRCPCH

Role: PRINCIPAL_INVESTIGATOR

KEMRI-Wellcome Trust Research Programme and Imperial College London

Locations

Baraka Clinic

Nairobi, Mathare, Kenya

Countries

Kenya

References

Jones KD, Hunten-Kirsch B, Laving AM, Munyi CW, Ngari M, Mikusa J, Mulongo MM, Odera D, Nassir HS, Timbwa M, Owino M, Fegan G, Murch SH, Sullivan PB, Warner JO, Berkley JA. Mesalazine in the initial management of severely acutely malnourished children with environmental enteric dysfunction: a pilot randomized controlled trial. BMC Med. 2014 Aug 14;12:133. doi: 10.1186/s12916-014-0133-2.

Reference Type: DERIVED

PMID: 25189855 (View on PubMed)

Other Identifiers

SSC 2223

Identifier Type: OTHER

Identifier Source: secondary_id

KEMRI_CT_2013/0016

Identifier Type: -

Identifier Source: org_study_id