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NCT Number: NCT05793294

Child Health, Nutrition and Microbiome Development

Childhood malnutrition is a global public health issue with devastating consequences on the health, well-being, and psychosocial development of children. Emerging evidence suggests that malnourished children have immature gut microbiota compared to age-matched healthy controls and it does not repair even after nutritional interventions. The present study aims to characterize how the gut microbiome develops during the first two years of life in children residing in malnutrition endemic areas of Khyber Pakhtunkhwa, the region with the highest prevalence of childhood malnutrition in Pakistan and the region.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

1 day–28 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Khyber Medical University, Peshawar, Khyber Pakhtunkhwa, Pakistan

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About this study

Malnutrition in children remains a global public health challenge. The consequences are often severe and deadly, particularly in low- and middle-income countries where malnutrition contributes to ~half of deaths in children under five years of age. Pakistan is among those nations with the highest burden of stunting (40.2%), wasting (17.7%), and micronutrient deficiency in children under five years of age. Recently, scientists discovered that the trillions of microbes (gut microbiome) that live in the human gut affect the nutritional status and overall health of children during the initial years of life. In this context, research studies from developing countries, where malnutrition is common, have reported an impaired or immature gut microbiome in malnourished (stunted, wasted, and underweight) children compared to matched healthy controls and it does not repair even after nutritional intervention. Therefore, a nutritional intervention strategy that does not take into account the gut microbiome microbiota will fail to ameliorate the long-term consequences of malnutrition.

In this prospective cohort study from Pakistan, healthy infants (n=70) aged 0 - 28 days will be recruited from rural and remote areas of District Swat and followed at 3, 6, 12, 18 and 24 months. Ante-natal and postnatal history, Dietary intake data, dietary diversity, Infant and young child feeding (IYCF practices), and Health outcomes data will be collected at baseline and followup. The investigators will also collect dry blood spot, stool and oral swab samples and conduct anthropometric assessments of both mother and the baby at each time point. Advanced, next-generation sequencing technology will be used to explore gut microbiome diversity and functional potential.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy infants aged 0 - 28 days
  • Born to parents residing in rural and remote areas of District Swat
  • Living in separate households
  • Parents/caregivers have no plans to move out of the stud site for at least one year after enrollment in the study.

Exclusion criteria

  • Child born to underage (<18 years old) mother.
  • Infants born with severe acute or chronic medication conditions that require hospitalization or prolonged use of medication or both or the infant is diagnosed with enteropathies.
  • Whose parents refused to provide informed consent to participate in the study.
  • Weight of the child is <1500 gm.

Treatment and study plan

Primary outcomes

  1. Gut microbiome profile

    Time frame: 2 years

    Next generation sequencing to asses changes in gut microbiome diversity and functional potential at 0, 3, 6, 9, 12, 18 and 24 months of age. These data will then be categorised on the basis of nutritional status (Healthy, Stunting, Wasting), dietary patterns and health status.

Sponsors and collaborators

Lead sponsor

Khyber Medical University Peshawar

Other

Collaborators

  • Abdul Wali Khan University Mardan
  • National Institutes of Health, Pakistan
  • University of Bern
  • University of Reading

Registry information

Official study title

Nutritional Status, Health and Gut Microbiome Development in Children; a Prospective Cohort Study From Pakistan

Acronym: CHAMP

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Mar 31, 2023
Registry last updated
Jan 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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