Trial · Interventional

CompletedPhase 2Registry data

Therapeutic Approaches to Malnutrition Enteropathy

Short name TAME

NCTNCT03716115Other id011724 QM

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 2
Enrollment: 125 participants (actual)
Sponsor: Queen Mary University of London · Other
Design: Randomized · Open label (no masking)
Countries: 2 countries
Zambia, Zimbabwe
Start: 4 May 2020
Primary completion: 27 Apr 2021
Completion: 27 Apr 2021
First posted: 23 Oct 2018
Last update posted: 27 Sept 2021
Conditions: Severe Acute Malnutrition

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202020212022

Ph 2
TAME
NCT03716115
4 May 2020 to 27 Apr 2021

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

Colostrum high protein powder (Neovite)Dietary supplement
N-Acetyl Glucosamine (GInNAC)Drug
TeduglutideDrug
BudesonideDrug

Arms5

Experimental
Colostrum
Colostrum high protein powder (Neovite) given orally or through NG tube 1.5g daily, in addition to standard care following WHO guidelines for management of SAM.
Experimental
GInNAC
N-Acetyl glucosamine (GInNAC). Given orally (1g three times daily) for 14 days, gradually increased from 0.5g to avoid osmotic diarrhoea, in addition to standard care following WHO guidelines for management of SAM.
Experimental
Teduglutide
Teduglutide s/c. Administration by subcutaneous injection (0.5mg/kg/day) daily for 14 days, in addition to standard care following WHO guidelines for management of SAM.
Experimental
Budenoside
Budesonide 3mg orally daily for 14 days, then rapidly tapered, in addition to standard care following WHO guidelines for management of SAM.
No intervention
Standard care
Standard care following WHO guidelines for management of SAM.

Primary outcomes1

Outcomes the sponsor listed as primary.

Composite measure of concentration of three faecal inflammatory markers
Time frame · 14-18 days
Registry description
Composite measure of concentration of three faecal inflammatory markers (myeloperoxidase, neopterin, alpha1-antitrypsin) measured by ELISA

Secondary outcomes(16)

Lactulose:rhamnose ratio
Time frame · 14-18 days
Registry description
Lactulose:rhamnose ratio of concentration in urine samples collected over 2 hours following oral administration of test dose
Plasma lipopolysaccharide (LPS)
Time frame · 14-18 days
Registry description
Plasma LPS concentration measured by limulus amoebacyte lysate assay
Plasma biomarker lipopolysaccharide binding protein (LBP)
Time frame · 14-18 days
Registry description
Plasma LBP concentration measured by ELISA
Plasma fatty acid binding protein (FABP)
Time frame · 14-18 days
Registry description
Plasma FABP concentration measured by ELISA
Plasma soluble CD14
Time frame · 14-18 days
Registry description
Plasma concentration of soluble CD14 measured by ELISA
Plasma CD163
Time frame · 14-18 days
Registry description
Plasma concentration of CD163 measured by ELISA
Plasma CRP
Time frame · 14-18 days
Registry description
Plasma concentration of C-reactive protein measured by ELISA
Plasma albumin
Time frame · 14-18 days
Registry description
Plasma concentration of albumin measured by ELISA
Mortality
Time frame · 14 days and 28 days
Registry description
Number of deaths in each treatment allocation group
Adverse events
Time frame · 14 days and 28 days
Registry description
Number of adverse events in each treatment allocation group
Change in weight and length
Time frame · 14 days and 28 days
Registry description
Change in weight and length measured by experienced nurses and expressed as change in weight-for-length z score compared to WHO standard
Days with diarrhoea
Time frame · 14-18 days
Registry description
Number of days during which diarrhoea was experienced assessed by experienced nurses
Days with fever
Time frame · 14-18 days
Registry description
xv. Days with fever (two or more recordings of core temperature of 37.8oC or higher in any 24 h period)
Villus height: crypt depth ratio
Time frame · 14-18 days
Registry description
Change in villus height and crypt depth measured in endoscopic biopsies (Lusaka only)
Epithelial leakiness
Time frame · 14-18 days
Registry description
Leakage of fluorescein into gut lumen assessed by Watson score during confocal laser endomicroscopy (Lusaka only)
Tertiary Objectives-Tertiary Endpoints- Exploratory work on glyscosylation
Time frame · 14-18 days
Registry description
Glycosylation in saliva and biopsies

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2024

1 result

Malnutrition enteropathy in Zambian and Zimbabwean children with severe acute malnutrition: A multi-arm randomized phase II trial.

Chandwe et al. 2024Nature communicationscited by 9

PMID 38632262PMC11024201DOI 10.1038/s41467-024-45528-0PUB-38632262

CC BY1 result

Download PDF See results (1)

More studies

1 study on this page

Indexing hint: Clinical trial · 2019

TAME trial: a multi-arm phase II randomised trial of four novel interventions for malnutrition enteropathy in Zambia and Zimbabwe - a study protocol.

Kelly et al. 2019BMJ opencited by 9

PMID 31727642PMC6887014DOI 10.1136/bmjopen-2018-027548PUB-31727642

CC BY

Download PDF

Eligibility

Who could join, as posted.

Sex: All
Age: from 6 Months up to 59 Months
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: 1. Age 6 - 59 months, of either sex; 2. Inpatient in the paediatric wards of one of the research sites; 3. Hospitalised with Severe Acute Malnutrition (SAM, defined using WHO definition: weight-for-length z score of less than -3, or mid upper arm circumference of less than 11.5cm, and/or bilateral pedal oedema); 4. Clinically stable\*; 5. With written, informed consent from the primary caregiver(s); the child cannot be enrolled if the primary caregiver(s) cannot give consent. * Judged by the medical team on a case by case basis, but in general a child without shock, hypothermia, hypoglycaemia or reduced conscious level. Exclusion Criteria: 1. Clinically unstable\*; 2. Less than 5kg body weight; 3. Neurological disability which would explain or partly explain poor feeding; 4. Oro-facial abnormalities which would explain or partly explain poor feeding; 5. Caregiver unwilling to consent to child HIV testing; 6. Haemoglobin concentration \< 6 g/dl at the time of enrolment; 7. Caregiver unwilling to remain in hospital for the duration of the study treatment; 8. Any underlying condition, other than HIV, which in the opinion of the investigator would put the subject at undue risk of failing study completion or would interfere with analysis of study results; 9. Contraindication to any of the trial treatments (e.g. allergy to cow's milk protein). * As assessed by the medical team on a case-by-case basis, but in general a clinically unstable state would include shock, hypothermia, hypoglycaemia or reduced conscious level.

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