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

Chandwe K, Bwakura-Dangarembizi M, Amadi B, Tawodzera G, Ngosa D, Dzikiti A, Chulu N, Makuyana R, Zyambo K, Mutasa K, Mulenga C, Besa E and 17 more

Show all authors

Sturgeon JP, Mudzingwa S, Simunyola B, Kazhila L, Zyambo M, Sonkwe H, Mutasa B, Chipunza M, Sauramba V, Langhaug L, Mudenda V, Murch SH, Hill S, Playford RJ, VanBuskirk K, Prendergast AJ, Kelly P

Nature communications17 Apr 2024Cited by 9 (Europe PMC)

PMID38632262PMCIDPMC11024201DOI10.1038/s41467-024-45528-0PepBankPUB-38632262

Download PDF PubMedAsk about this study

Jump to 1 result

Summary

Malnutrition underlies almost half of all child deaths globally. Severe Acute Malnutrition (SAM) carries unacceptable mortality, particularly if accompanied by infection or medical complications, including enteropathy. We evaluated four interventions for malnutrition enteropathy in a multi-centre phase II multi-arm trial in Zambia and Zimbabwe and completed in 2021. The purpose of this trial was to identify therapies which could be taken forward into phase III trials. Children of either sex were eligible for inclusion if aged 6-59 months and hospitalised with SAM (using WHO definitions: WLZ <-3, and/or MUAC <11.5 cm, and/or bilateral pedal oedema), with written, informed consent from the primary caregiver. We randomised 125 children hospitalised with complicated SAM to 14 days treatment with (i) bovine colostrum (n = 25), (ii) N-acetyl glucosamine (n = 24), (iii) subcutaneous teduglutide (n = 26), (iv) budesonide (n = 25) or (v) standard care only (n = 25). The primary endpoint was a composite of faecal biomarkers (myeloperoxidase, neopterin, α₁-antitrypsin). Laboratory assessments, but not treatments, were blinded. Per-protocol analysis used ANCOVA, adjusted for baseline biomarker value, sex, oedema, HIV status, diarrhoea, weight-for-length Z-score, and study site, with pre-specified significance of P < 0.10. Of 143 children screened, 125 were randomised. Teduglutide reduced the primary endpoint of biomarkers of mucosal damage (effect size -0.89 (90% CI: -1.69,-0.10) P = 0.07), while colostrum (-0.58 (-1.4, 0.23) P = 0.24), N-acetyl glucosamine (-0.20 (-1.01, 0.60) P = 0.67), and budesonide (-0.50 (-1.33, 0.33) P = 0.32) had no significant effect. All interventions proved safe. This work suggests that treatment of enteropathy may be beneficial in children with complicated malnutrition. The trial was registered at ClinicalTrials.gov with the identifier NCT03716115.

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study1

1 result from studies that gave the peptide. 1 result from people.

01HumanRandomized controlled trialEfficacy outcome
In children with complicated SAM, teduglutide reduced the composite mucosal damage endpoint versus standard care (effect size -0.89; 90% CI -1.69,-0.10; P = 0.07).
In plain wordsIn children with complicated malnutrition, teduglutide reduced the combined gut-damage marker score compared with standard care.
Peptide
Teduglutide
Outcome
DecreaseComposite mucosal damage biomarkers
Study
n: not reported in source
Comparator
Standard care
Analysis
Primary
Outcome group
Gastrointestinal protection · Gastrointestinal
Studied dose
Dose not stated · subcutaneous · 14 daysAs given in this study (human).
Measurements
Effect size
−0.89
reported result
90% CI
−1.69 to −0.1
reported result
P
0.07
reported result
Source sentences
Summary
Teduglutide reduced the primary endpoint of biomarkers of mucosal damage (effect size -0.89 (90% CI: -1.69,-0.10) P = 0.07)
3 context sentences(design, population, supporting numbers)
Summary · context
The primary endpoint was a composite of faecal biomarkers (myeloperoxidase, neopterin, α₁-antitrypsin).
Summary · context
Per-protocol analysis used ANCOVA, adjusted for baseline biomarker value, sex, oedema, HIV status, diarrhoea, weight-for-length Z-score, and study site, with pre-specified significance of P < 0.10.
Summary · context
We randomised 125 children hospitalised with complicated SAM to 14 days treatment with (i) bovine colostrum (n = 25), (ii) N-acetyl glucosamine (n = 24), (iii) subcutaneous teduglutide (n = 26), (iv) budesonide (n = 25) or (v) standard care only (n = 25).
Show in the study text Report a problemFND-3863226201

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 2NCT03716115

Therapeutic Approaches to Malnutrition Enteropathy

Queen Mary University of Londonn = 1254 May 2020 to 27 Apr 2021

Severe Acute Malnutrition

Trial page ClinicalTrials.govUpdated 27 Sept 2021

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 1
27 Oct 2026, 16:37 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

Publication types

MeSH terms

PepBank is a research reference. Talk to a doctor before you use any peptide.