The Impact of Maternal Microbes on Infant Health Programming (MAMI)

February 8, 2021 updated by: Maria Carmen Collado, Institute of Agrochemistry and Food Technology, National Research Council

The Power of Maternal Microbes on Infant Health

MAMI aims to characterize maternal microbes to be transferred to neonates and determine their function in infant health programming.

Study Overview

Status

Completed

Conditions

Detailed Description

Recent reports suggest that early microbial colonization has an important role for in promoting health. This may contribute to reduce the risk of chronic diseases such as obesity, allergies and inflammatory conditions. Advances in understanding host-microbe interactions imply that maternal microbiota plays a crucial role on health programming. This process begins in utero and it is modulated by mode of delivery and diet. The investigator's previous data has shown that i) specific shifts in milk microbial composition are associated with lactation time and mode of delivery, ii) milk microbes drive the infant microbiota composition; iii) maternal microbiota dysbiosis may be transferred to the infant. However, factors defining maternal microbiota and its biological role upon infant's health are not yet fully understood. Hence, this project aims to characterize maternal microbes to be transferred to neonates and determine their function in infant health programming. The specific aims are:(1) understanding how the maternal microbiome is influenced by host and environmental factors;(2) characterizing the microbial core and bioactive compounds transmitted to the offspring mainly via breastfeeding and their key roles in the microbial modulation and host response;(3) understanding the interactions among breast milk bioactive compounds and their role in infant health;(4) shedding light on how maternal microbes influence the infant immune system.

Results obtained will demonstrate the interaction between infant nutrition, microbes and host response in early life and its key role in health programming, enabling new applications in the field of personalized nutrition & medicine.

Study Type

Observational

Enrollment (Actual)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Valencia, Spain
        • Fundacion Investigacion Sanitaria INCLIVA
      • Valencia, Spain
        • Hospital Universitario y Politécnico La Fe

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Families located on the Mediterranean area

Description

Inclusion Criteria:

  • Age> 18 years.
  • Healthy woman (no medication, no diabetes, no pre-gestational thyroid problems)
  • Postpartum woman (beginning of the puerperium).

Exclusion criteria:

  • Non-compliance with any of the inclusion criteria.
  • Medication and drugs
  • Health problems at the immunological and metabolic levels.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microbiota composition
Time Frame: from birth to 24 month
Dominant microbial species maternal and infant samples (using qPCR and sequencing -approaches analysis
from birth to 24 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal diet
Time Frame: from birth to12 month
Maternal diet (FFQ) during gestation and 12 month post-partum
from birth to12 month
Maternal BMI
Time Frame: pre-gestational
To check Body Mass Index (kg/cm2)
pre-gestational
Maternal weight
Time Frame: pre-gestational and from birth to 12 months post-partum
To check Weight gain over pregnancy (kg) and weight during lactation
pre-gestational and from birth to 12 months post-partum
To identify maternal factors affecting microbiota: antibiotics
Time Frame: pre-gestational
antibiotics treatment during gestation (number of treatments)
pre-gestational
To identify the impact of mode of delivery
Time Frame: Birth
Mode of delivery type: Vaginal/C-section (elective or non-elective)
Birth
Infant weight
Time Frame: from birth to 24 month
Infant weight (kg)
from birth to 24 month
Infant height
Time Frame: from birth to 24 month
Infant height (cm)
from birth to 24 month
Infant Diet
Time Frame: from bith to 24 month
Exclusive breastfeeding time (months), breastfeeding duration and time of introduction of complementary food
from bith to 24 month
Fecal short-chain fatty acids
Time Frame: from birth to 24 month
Determine the relationship between fecal microbiota composition and fecal short chain fatty acids
from birth to 24 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Agrochemistry and Food Technology, National Research Council

Collaborators

Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Fundación para la Investigación del Hospital Clínico de Valencia
Hospital Universitario La Fe
Hospital de Manises
CS Serreria II
CS La Eliana

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2015

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

March 21, 2018

First Submitted That Met QC Criteria

June 10, 2018

First Posted (Actual)

June 12, 2018

Study Record Updates

Last Update Posted (Actual)

February 9, 2021

Last Update Submitted That Met QC Criteria

February 8, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 639226

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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