NCT05793294

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 malnutrition endemic areas of Khyber Pakhtunkhwa, the region with the highest prevalence of childhood malnutrition in Pakistan and the region.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2024

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 31, 2023

Completed
1.1 years until next milestone

Study Start

First participant enrolled

May 10, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2026

Completed
Last Updated

January 5, 2026

Status Verified

January 1, 2026

Enrollment Period

1.1 years

First QC Date

March 19, 2023

Last Update Submit

January 1, 2026

Conditions

MalnutritionStuntingWastingUnderweightOverweight and Obesity

Keywords

Nutritional statusGut microbiomeHealthAnthropometryMalnutritionStuntingWastingUnderweightOverweightGrowth

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Birth cohort

All infants age 0 - 28 days will be recruited and followed until 24 months of age

Eligibility Criteria

Age1 Day - 28 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Khyber Medical University

Peshawar, Khyber Pakhtunkhwa, 25110, Pakistan

Location

Tehsil Matta

Swāt, Khyber Pakhtunkhwa, Pakistan

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum, plasma, and stool samples will be stored

MeSH Terms

Conditions

MalnutritionGrowth DisordersCachexiaThinnessOverweightObesity

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsWeight LossBody Weight ChangesBody WeightSigns and SymptomsOvernutrition

Study Officials

  • Muhammad Shahzad, PhD

    Khyber Medical University

    PRINCIPAL INVESTIGATOR

  • Zia Ul Haq, PhD

    Khyber Medical University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
24 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2023

First Posted

March 31, 2023

Study Start

May 10, 2024

Primary Completion

May 30, 2025

Study Completion

May 31, 2026

Last Updated

January 5, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

PA(2)