Mesalamine in Environmental Enteropathy

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

Kenya

Study Type

Interventional

Intervention

Mesalamine

Placebo granules

About this trial

This is an interventional treatment trial for Malnutrition

Eligibility Criteria

1 Year - 5 Years (Child)All SexesDoes not accept 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).

Sites / Locations

Baraka Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Mesalamine

Placebo granules

Arm Description

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

Placebo granules

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

Changes in height

mm/day

Changes in levels of anti-Endotoxin Core IgG (EndoCAb)

Changes in fecal calprotectin levels

Changes in plasma soluble-CD14

Changes in plasma beta-2 microglobulin

Changes in plasma neopterin

Changes in weight

g/kg/day

Changes in mid-upper arm circumference

mm/day

Changes in C-Reactive Protein

Full Information

NCT ID

NCT01841099

First Posted

April 15, 2013

Last Updated

July 10, 2014

Sponsor

Kelsey Jones

Collaborators

Imperial College London

1. Study Identification

Unique Protocol Identification Number

NCT01841099

Brief Title

Mesalamine in Environmental Enteropathy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2014

Overall Recruitment Status

Completed

Study Start Date

June 2013 (undefined)

Primary Completion Date

May 2014 (Actual)

Study Completion Date

May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Kelsey Jones

Collaborators

Imperial College London

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malnutrition

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

44 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mesalamine

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo granules

Arm Type

Placebo Comparator

Arm Description

Placebo granules

Intervention Type

Drug

Intervention Name(s)

Mesalamine

Other Intervention Name(s)

Mesalazine, Pentasa (trade name)

Intervention Description

Mesalamine granules

Intervention Type

Drug

Intervention Name(s)

Placebo granules

Intervention Description

Provided by Ferring Pharma

Primary Outcome Measure Information:

Title

Frequency of adverse events/serious adverse events

Description

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

Time Frame

Day 0 to day 28 and day 0 to day 56

Title

Compliance with treatment

Description

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

Time Frame

Day 0 to day 28

Secondary Outcome Measure Information:

Title

Changes in height

Description

mm/day

Time Frame

Day 0 to 28 and day 0 to day 56

Title

Changes in levels of anti-Endotoxin Core IgG (EndoCAb)

Time Frame