NCT06155474: P-MAM

Effects of Prebiotics on Metagenomic Diversity and Abundance in Young Children With Acute Malnutrition

Status unknown NA Last updated 4 December 2023

What this trial tests

NA trial testing Prebiotic galacto-oligosaccharide (GOS) Powder in Child Malnutrition in 200 participants. Status unknown.

Timeline

1 January 2024

Primary endpoint
1 March 2024

1 June 2024

Quick facts

Lead sponsor	University of the Punjab
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	200
Start date	1 January 2024
Primary completion	1 March 2024
Estimated completion	1 June 2024
Sites	1 location across Pakistan

Drugs / interventions tested

• Prebiotic galacto-oligosaccharide (GOS) Powder
• Starch Only
• RUTF + Starch

Conditions studied

• Child Malnutrition — all drugs for Child Malnutrition →

Sponsor

University of the Punjab

Who can join

Adults 6 Months to 59 Months, any sex, with Child Malnutrition. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Malnutrition is a major global public health issue, contributing to poor health and early morbidities in children under five, particularly in developing countries. In 2021, 5 million children died worldwide due to infectious diseases or malnutrition, with Pakistan having the highest under-five mortality rate. With a population of approximately 229 million, Pakistan is the fifth most populous country in the world. In Pakistan, under-five mortality is 63.3 per 1000 live births which has declined from 139.8 in 1990 to 63.3 in 2021 (WHO, 2022, UNICEF, 2023). The monsoon season's massive flooding in Pakistan has worsened the humanitarian situation, endangering the already vulnerable population. UNICEF reports high rates of acute malnutrition, political instability, economic decline, and coronavirus disease 2019 effects. However, there is limited evidence on the efficacy of probiotics for infants in Pakistan.

Metagenomics is the study of microorganisms' genomes, examining all microorganisms in an ecological site's genomes. It involves extracting and sequencing DNA using high-throughput techniques. Scientists can identify genes with significant features using computer analysis. The distal intestine contains around one trillion organisms per milliliter of luminal contents, and understanding their potential for energy and nutrient harvest is crucial in malnourished individuals.

Alpha diversity is the analysis of species diversity in a sample, measured by observed species index, Chao1 index, Shannon index, Simpson index, and good-coverage index. It is proportional to the first four values and indicates less undiscovered species. The distal intestine contains around one trillion organisms per milliliter of luminal contents, with an increased capacity for energy harvest in malnourished individuals.

The present study aims to measure the following objectives. i. -To estimate the microbiome degree of diversity among malnutrition children micro-biota defined by 16 Svedberg (S) ribosomal ribonucleic acid gene sequencing.

ii. -To evaluate the interpersonal differences in the structure and functioning of the gut microbiome that affect a person's vulnerability to malnutrition.

iii. -To determine how microbiomes are shaped by host genotypes, environmental exposures, including exposure to malnutrition in children mothers, and other family members, nutritional status, and lifestyles, including diet.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effects of prebiotics on microbial diversity and abundance in young children with acute malnutrition: study protocol for a multi-centered, double-blinded randomized controlled trial.
   Saleem J, Zakar R, Iqbal S, Arshad M, et al · · 2024 · PMID 39593072 · DOI 10.1186/s13063-024-08647-z
2. Effects of prebiotics on microbial diversity and abundance in young children with acute malnutrition: Study protocol for a multi-centered, double-blinded randomized controlled trial
   Saleem J, Zakar R, Iqbal S, Arshad M, et al · · 2024 · DOI 10.21203/rs.3.rs-4514752/v1