Understanding gut microbiome development in malnourished children
Nutritional Status, Health and Gut Microbiome Development in Children; a Prospective Cohort Study From Pakistan
This study looks at how the gut bacteria of healthy infants from areas with malnutrition develop over two years to see how it relates to their diet and health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 70 (estimated) |
| Ages | 1 Day to 28 Days |
| Sex | All |
| Sponsor | Khyber Medical University Peshawar Academic / other |
| Locations | 2 sites (Peshawar, KP and 1 other locations) |
| Trial ID | NCT05793294 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the development of the gut microbiome in healthy infants from malnutrition-endemic areas of Khyber Pakhtunkhwa, Pakistan. It will follow 70 infants aged 0 to 28 days over a two-year period, collecting data on dietary intake, feeding practices, and health outcomes at multiple time points. The research seeks to understand how malnutrition affects gut microbiota and the implications for nutritional interventions. By characterizing these relationships, the study aims to inform future strategies to combat childhood malnutrition.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy infants aged 0 to 28 days born to parents residing in rural and remote areas of District Swat.
Not a fit: Patients who may not benefit from this study include those with severe medical conditions requiring hospitalization or those born to underage mothers.
Why it matters
Potential benefit: If successful, this study could lead to improved nutritional interventions that consider gut microbiome health, ultimately reducing childhood malnutrition.
How similar studies have performed: While there is emerging evidence regarding the gut microbiome's role in malnutrition, this specific approach in the context of Khyber Pakhtunkhwa is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Peshawar, KP and 1 other locations
- Khyber Medical University — Peshawar, Kp, Pakistan (Recruiting)
- Tehsil Matta — Swāt, Kp, Pakistan (Recruiting)
Study contacts
- Principal investigator: Muhammad Shahzad, PhD — Khyber Medical University
- Study coordinator: Muhammad Shahzad, PhD
- Email: shahzad.ibms@kmu.edu.pk
- Phone: 00923459048796
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.