Microbiome and Malnutrition in Pregnancy (MMiP)

NCT05108675 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2024-07-15

No results posted yet for this study

Summary

Nutritional status during pregnancy plays an important role in maternal health and birth outcomes. While few factors impacting nutritional status during pregnancy have been identified, studies of undernutrition in children have revealed a key role for the gut microbiome. Remarkably, studies examining the dynamics of the maternal gut microbiome before and during pregnancy and its impact on birth outcomes are limited.

This study is being conducted to investigate how a mother's nutritional status and her gut microbiome during pregnancy contribute to the birth outcomes and health of her baby. The gut microbiome is the totality of microorganisms (e.g. bacteria, viruses, fungi) living in the gastrointestinal tract. This study will focus on married pregnant women 24 years and younger living in Matiari District in Pakistan. The focus is on younger women due to their vulnerability to undernutrition. Pregnant participants, and upon delivery, their newborns will be followed throughout pregnancy and for a year afterwards. Throughout this period, the investigators will collect stool samples, rectal swabs, blood samples, health assessments, nutritional and dietary assessments and birth/ labour details. The goal is to define the relationship between a mother's nutritional status and her microbiome dynamics during pregnancy and how they contribute to the birth outcomes and growth of her newborn. Investigators hypothesizes that alterations of the microbiota in the maternal gut (dysbiosis) is exacerbated by nutritional status or pathogen exposure during pregnancy. This impacts weight gain because of impaired nutrient absorption, and can lead to corresponding negative birth outcomes.

Conditions

  • Weight Gain, Pregnancy
  • Microbial Colonization
  • Pregnancy Related
  • Pregnancy Loss
  • Pregnancy Complications
  • Pregnancy; Parasitic Disease
  • Parasitic Disease
  • Microbial Disease
  • Infant Malnutrition
  • Malnutrition
  • Malnutrition in Pregnancy
  • Breastfeeding

Sponsors & Collaborators

  • The Hospital for Sick Children

    collaborator OTHER
  • University of Toronto

    collaborator OTHER
  • University of Calgary

    collaborator OTHER
  • Dalhousie University

    collaborator OTHER
  • University of Alberta

    collaborator OTHER
  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV
  • Aga Khan University

    lead OTHER

Principal Investigators

  • Zulfiqar Bhutta · Aga Khan University

Eligibility

Min Age
17 Years
Max Age
24 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-24
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05108675 on ClinicalTrials.gov