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

Summary

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.

Conditions

• Child Malnutrition

Interventions

DIETARY_SUPPLEMENT

Prebiotic galacto-oligosaccharide (GOS) Powder

Prebiotic GOS Powder is a galacto-oligosaccharide ingredient low in mono-sugars. Scientific studies have shown positive effects of oligosaccharides, among which galacto-oligosaccharides, on growth of bifidobacterial, stool consistency bowel function and transit time, support of natural defenses and mineral absorption. The product mainly consists of 97% dry matter with 69% prebiotic GOS, 23% lactose and 5% glucose and galactose as monosaccharides. These prebiotics have β-(4) glycosidic linkages and have been proven as safe product

DIETARY_SUPPLEMENT

Starch Only

The Starch Solution is a low-fat diet.

DIETARY_SUPPLEMENT

RUTF + Starch

ready-to-use therapeutic food and The Starch Solution is a low-fat diet.

Sponsors & Collaborators

• University of Veterinary and Animal Sciences, Lahore - Pakistan

  collaborator OTHER

• University of the Punjab

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

6 Months

Max Age

59 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-01-01

Primary Completion

2024-03-01

Completion

2024-06-01

Countries

• Pakistan

Study Locations