Overweight and Obesity Clinical Trial
— CHAMPOfficial title:
Nutritional Status, Health and Gut Microbiome Development in Children; a Prospective Cohort Study From Pakistan
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.
Status | Recruiting |
Enrollment | 70 |
Est. completion date | May 31, 2026 |
Est. primary completion date | May 30, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 1 Day to 28 Days |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Pakistan | Khyber Medical University | Peshawar | KP |
Pakistan | Tehsil Matta | Swat | KP |
Lead Sponsor | Collaborator |
---|---|
Khyber Medical University Peshawar | Abdul Wali Khan University Mardan, National Institute of Health, Pakistan, University of Bern, University of Reading |
Pakistan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Gut microbiome profile | 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. | 2 years |
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