Child Health, Nutrition and Gut Microbiome Development

Study Overview
=================
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.

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 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 - 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, Infant and young child feeding (IYCF practices), and Health outcomes data will be collected every three months for two years. The investigators 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.

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

Conditions
-----------------
Wasting, Malnutrition, Stunting, Underweight, Overweight and Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 14 Days

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Birth cohort<br>All infants age 0 - 14 days will be recruited and followed until 24 months of age | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nutritional status, Gut microbiome, Health, Anthropometry, Malnutrition, Stunting, Wasting, Underweight, Overweight, Growth