CHAMP: Child Health, Nutrition and Gut Microbiome Development

Sponsor

Khyber Medical University Peshawar (Other)

Overall Status

Recruiting

CT.gov ID

NCT05793294

Collaborator

University of Reading (Other), Abdul Wali Khan University Mardan (Other), University of Bern (Other), National Institute of Health, Pakistan (Other)

Enrollment

Locations

25.5

Anticipated Duration (Months)

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 Newly Merged Districts of Khyber Pakhtunkhwa, the region with the highest prevalence of childhood malnutrition in Pakistan and the region.

Condition or Disease	Intervention/Treatment	Phase
Gut Microbiome Development

Detailed Description

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 our 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 (stunting, wasting, 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 - 14 days will be recruited from District Khyber and followed every 4 months for two years. Ante-natal and postnatal history, Dietary intake data, dietary diversity, IYCF practices, and Health outcomes data will be collected every three months for two years. We will also collect Blood and stool 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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

70 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Feb 15, 2023

Anticipated Primary Completion Date :

Feb 28, 2024

Anticipated Study Completion Date :

Mar 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Birth cohort All infants age 0 - 14 days will be recruited and followed until 24 months of age

Outcome Measures

Primary Outcome Measures

Gut microbiome profile [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Day to 14 Days

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Healthy infants aged 0 - 14 days
Born to parents from the district Khyber
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.
Twin or triplets
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.