An observational study in Malnutrition, Stunting and Wasting, sponsored by Khyber Medical University Peshawar. Active, not recruiting at 2 sites in Pakistan. Open to participants aged 1 Day to 28 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-05.
Sponsored by Khyber Medical University Peshawar · Observational
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.
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.
1,277 studies on the registry are indexed under Malnutrition; 230 are open to participants now.
This study's enrollment of 70 is below the median of 206 across 393 observational studies indexed under Malnutrition.
Browse Malnutrition studies →Khyber Medical University Peshawar is the lead sponsor of 54 studies on the registry; 13 are open to participants now.
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The eligible participants (neonates) will be identified by searching the health and immunization record of the recently born children in the study area. The record will be obtained from the health facilities serving the study area. Eligible participants will be recruited with the help of trained Lady Health Workers.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All infants age 0 - 28 days will be recruited and followed until 24 months of age
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.
Time frame: 2 years
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Khyber Medical University Peshawar