Therapeutic Approaches to Malnutrition Enteropathy

Summary

The TAME study will evaluate four new approaches which will be compared against the standard care currently in use in the treatment of malnutrition enteropathy in children with severe acute malnutrition. A high pathogen burden causes damage to the intestinal mucosa which exacerbates nutritional impairment and leads to further susceptibility to infection and impaired epithelial regeneration. Enteropathy is characterised by multiple epithelial breaches, microbial translocation from gut lumen to systemic circulation and systemic inflammation.The trial will evaluate the potential impact of four interventions (colostrum, N-acetyl glucosamine, teduglutide, and budesonide) given for 14 days, which aim at mucosal restoration. The trial will determine if repairing damage to the small intestinal mucosa leads to the reduction of systemic inflammation and thus lessening the nutritional impairment, and so if this contributes to the reduction of mortality in children.

In Zambia only, endoscopic biopsies and confocal laser endomicroscopy will be used to evaluate response and confirm safety at a mucosal level.

Identifying an agent or agents which contribute most to mucosal healing will then ultimately lead to further large phase 3 trial in which the agent(s) will be further evaluated.

The trial also anticipates to gain a more in depth understanding of pathophysiology and may identify where current management strategies of treating malnutrition enteropathy in children are failing.

Conditions

• Severe Acute Malnutrition

Interventions

DIETARY_SUPPLEMENT

Colostrum high protein powder (Neovite)

Bovine colostrum provided as powder will be reconstituted and administered orally or via NG tube.

DRUG

N-Acetyl Glucosamine (GInNAC)

N-Acetyl glucosamine provided as powder will be reconstituted and administered orally or via NG tube.

DRUG

Teduglutide

Teduglutide will be administered daily as subcutaneous injection

DRUG

Budesonide

Budesonide liquid (as marketed for nebulisation) will be administered orally or bia NG tube daily.

Sponsors & Collaborators

• Queen Mary University of London

  lead OTHER

Principal Investigators

• Paul Kelly, MD · Queen Mary University of London

• Beatrice Amadi, MD · University Teaching Hospital, Lusaka, Zambia

• Andrew Prendergast, PhD · Queen Mary University of London

• Mutsa Bwakura-Dangarembizi, MB · Parirenyatwa Hospital, Harare, Zimbabwe

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

6 Months

Max Age

59 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-05-04

Primary Completion

2021-04-27

Completion

2021-04-27

Countries

• Zambia
• Zimbabwe

Study Locations