Microbiome and Malnutrition in Pregnancy (MMiP)

NCT05108675 | Unknown DMC

• 1 other identifier: 51950
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Maternal Malnutrition, Gut Dysbiosis, Infant Health

Outcome Measures

Primary Outcomes (3)

• To assess if alterations of the microbiota in the maternal gut (dysbiosis) are corelated with changes in maternal gestational weight gain

  The primary endpoint will be the change in maternal gestational weight gain (GWG) during pregnancy, measured between the first (8-16 weeks post-conception) and second time point (30-34 weeks post-conception)

  8-20 weeks post-conception, 30-34 weeks post-conception

• To determine the correlation between maternal microbiome dysbiosis during pregnancy and birth weight.

  The primary endpoint will be change in birthweight measured in kilograms.

  At birth

• To determine the correlation between maternal microbiome dysbiosis during pregnancy and infant growth

  The primary endpoint will be change in WHO z-scores during first year of infant's life. These z-scores will be calculated for weight (measured in kg), length and head circumference (measured in cm).

  3month, 6month and 12month postpartum

Secondary Outcomes (56)

• Anthropometrics

  8-16 weeks post-conception, 30-34 weeks post-conception, delivery, 3-months post-partum, 6 months post-partum and 12 months post-partum ]

• Anthropometrics: Maternal middle upper arm circumference

  8-16 weeks post-conception, 30-34 weeks post-conception, 3-months post-partum,and 12 months post-partum

• Anthropometrics: Maternal triceps skinfold thickness

  8-16 weeks post-conception, 30-34 weeks post-conception, 3-months post-partum, and 12 months post-partum

• Anthropometrics: Maternal height

  8-16 weeks post conception, 30-34 weeks post conception, delivery, 3 months post-partum and 12 months post partum

• Anthropometrics: Maternal weight

  8-16weeks post conception, 30-34 weeks post conception, delivery, 3 months post-partum and 12 months post-partum

Eligibility Criteria

• Age: 17 Years - 24 Years
• Gender Eligibility Details: Biological sex: as the study's primary aim is to investigate pregnancy, participation will be restricted to participants who are biologically female. However, the study is inclusive with respect to gender, including both cis-gendered and trans-gendered participants (biological female-to-male).
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

This study will examine young, married women ≤24 years living in Matiari District, Pakistan. The investigators focus on younger women, due to the lack of knowledge about their microbiome and their vulnerability to undernutrition

You may qualify if:

• Consent provided
• Married female aged 17-24 years
• In good general health, with no comorbidities
• Absence of COVID19 symptoms
• Intend to comply with study procedures and follow up

You may not qualify if:

• Women who do not meet the enrollment age criteria
• Women participating in interventional clinical trials
• Women who intend to leave the study area
• Women who cannot comply with study procedure's and follow-up
• Illness and other co-morbidities
• Signs of potential COVID19 infection
• BMI higher than 24.9 kg/m2
• Women who already have a member of their household participating
• Women who have taken antibiotics within the past 3 months
• Women who are past 16 weeks post- conception

Sponsors & Collaborators

• Aga Khan University: lead
• The Hospital for Sick Children: collaborator
• University of Toronto: collaborator
• University of Calgary: collaborator
• Dalhousie University: collaborator
• University of Alberta: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Research and Training Centre Matiari, Aga Khan University

Karachi, Sindh, 74000, Pakistan

Location

Related Publications (1)

• Wasan Y, Baxter JB, Spiegel-Feld C, Begum K, Rizvi A, Iqbal J, Hulst J, Bandsma R, Suleman S, Soofi S, Parkinson J, Bhutta ZA. Elucidating the dynamics and impact of the gut microbiome on maternal nutritional status during pregnancy, effect on pregnancy outcomes and infant health in rural Pakistan: study protocol for a prospective, longitudinal observational study. BMJ Open. 2024 Aug 12;14(8):e081629. doi: 10.1136/bmjopen-2023-081629.

  PMID: 39134435 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Stool and blood samples will be collected from mother and infant. Participants will have the option to have their blood samples biobanked for future genetic testing (This would be a separate study application in the future). More information on sample analysis can be found in section 10 of the protocol

MeSH Terms

Conditions

Gestational Weight Gain; Communicable Diseases; Pregnancy Complications; Parasitic Diseases; Infant Nutrition Disorders; Malnutrition; Breast Feeding

Condition Hierarchy (Ancestors)

Weight Gain; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infections; Disease Attributes; Pathologic Processes; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Nutrition Disorders; Nutritional and Metabolic Diseases; Feeding Behavior; Behavior

Study Officials

• Zulfiqar Bhutta

  Aga Khan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Zulfiqar A Bhutta MBBS, FRCPCH, FAAP, PhD

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: November 5, 2021
• Study Start: November 24, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: July 15, 2024

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: All sequence and metabolomics data will be made available within 12 months of study completion Supporting information will be shared at time of request
• Access Criteria: Supporting information will be shared upon request Sequence and metabolomics datasets will be made available without restriction

Locations

PA (1)