Effects of Prebiotics on Metagenomic Diversity and Abundance in Young Children With Acute Malnutrition
P-MAM
1 other identifier
interventional
200
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 17, 2023
CompletedFirst Posted
Study publicly available on registry
December 4, 2023
CompletedStudy Start
First participant enrolled
January 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2024
CompletedDecember 4, 2023
November 1, 2023
2 months
October 17, 2023
November 30, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Microbiome diversity
Microbiome diversity examination among malnourished children using 16 Svedberg (S) ribosomal ribonucleic acid gene sequencing. The microbiome diversity index measures the diversity of microbial species in malnourished children's gut microbiota, comparing it to reference or control populations. Higher values indicate greater diversity, providing insights into malnutrition's impact on gut microbiota composition.
8 Weeks
Secondary Outcomes (3)
Anthropometric Measurements
8 Weeks
Neurodevelopment Assessment
8 Weeks
Muscle mass accumulation
8 Weeks
Study Arms (3)
Healthy/Control (Starch)
PLACEBO COMPARATORThe Healthy Controls will be given starch packed in the same way as the active prebiotics
Malnutrition (RUTF + Starch)
EXPERIMENTALThe Malnutrition group with RUTF and Starch only. The RUTF will be given as per the WHO guidelines
Malnutrition (RUTF + prebiotics)
ACTIVE COMPARATORThe Malnutrition group with RUTF and Prebiotic only. The RUTF will be given as per the WHO guidelines
Interventions
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
ready-to-use therapeutic food and The Starch Solution is a low-fat diet.
Eligibility Criteria
You may qualify if:
- Acute malnutrition without complications, as defined by the World Health Organization (i.e., children with mid-upper arm circumference (MUAC) \<115 mm or weight-for-height z-score \<-3 or grade 1-2 bilateral edema who will be clinically well and alert with good appetite);
- Parental consent for the child to participate.
- Healthy children without any chronic or acute illness
You may not qualify if:
- Presence of any complications of severe malnutrition (severe dehydration, severe anemia, severe pitting edema, anorexia, hypothermia, high pyrexia, acute lower respiratory infection, or hypoglycemia) or immunocompromised.
- Children on antibiotic treatment for any disease in the last 3 months will be excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Public Health, University of the Punjab
Lahore, 54500, Pakistan
Related Publications (1)
Saleem J, Zakar R, Iqbal S, Arshad M, Shahzad R, Batool M, Nawaz M, Butt MS, Fischer F. 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. Trials. 2024 Nov 26;25(1):798. doi: 10.1186/s13063-024-08647-z.
PMID: 39593072DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- During trial conduct, the following groups will all be blinded to participants' allocation Healthy/Control, Malnutrition (RUTF) and Malnutrition (RTUF + prebiotics)
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
October 17, 2023
First Posted
December 4, 2023
Study Start
January 1, 2024
Primary Completion
March 1, 2024
Study Completion
June 1, 2024
Last Updated
December 4, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share