Mesalamine in Environmental Enteropathy

Malnutrition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01841099
• Other study ID #: KEMRI_CT_2013/0016
• Secondary ID: SSC 2223
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: April 15, 2013
• Last updated: July 10, 2014
• Start date: June 2013
• Est. completion date: May 2014

Study information

• Verified date: July 2014
• Source: KEMRI-Wellcome Trust Collaborative Research Program
• Contact: n/a
• Is FDA regulated: No
• Health authority: Kenya: Ethical Review CommitteeKenya: Pharmacy and Poisons Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 5 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malnutrition

Intervention

Drug:
• Mesalamine
Mesalamine granules
• Placebo granules
Provided by Ferring Pharma

Locations

Country	Name	City	State
Kenya	Baraka Clinic	Nairobi	Mathare

Sponsors (2)

Lead Sponsor	Collaborator
Kelsey Jones	Imperial College London

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of adverse events/serious adverse events	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	Day 0 to day 28 and day 0 to day 56	Yes
Primary	Compliance with treatment	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	Day 0 to day 28	No
Secondary	Changes in height	mm/day	Day 0 to 28 and day 0 to day 56	No
Secondary	Changes in levels of anti-Endotoxin Core IgG (EndoCAb)		Day 0 - Day 28 and Day 0 - Day 56	No
Secondary	Changes in fecal calprotectin levels		Day 0 - Day 28 and Day 0 - Day 56	No
Secondary	Changes in plasma soluble-CD14		Day 0 - Day 28 and Day 0 - Day 56	No
Secondary	Changes in plasma beta-2 microglobulin		Day 0 - Day 28 and Day 0 - Day 56	No
Secondary	Changes in plasma neopterin		Day 0 - Day 28 and Day 0 - Day 56	No
Secondary	Changes in weight	g/kg/day	Day 0 - Day 28 and Day 0 - Day 56	No
Secondary	Changes in mid-upper arm circumference	mm/day	Day 0 - Day 28 and Day 0 - Day 56	No
Secondary	Changes in C-Reactive Protein		Day 0 - Day 28, and Day 0 - Day56	No