Skip to main content
OpenTrials
Completed

NCT Number: NCT03552939

The Impact of Maternal Microbes on Infant Health Programming

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fundacion Investigacion Sanitaria INCLIVA, Valencia, Spain

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Microbiota composition

    Time frame: from birth to 24 month

    Dominant microbial species maternal and infant samples (using qPCR and sequencing -approaches analysis

Secondary outcomes

  1. Maternal diet

    Time frame: from birth to12 month

    Maternal diet (FFQ) during gestation and 12 month post-partum

  2. Maternal BMI

    Time frame: pre-gestational

    To check Body Mass Index (kg/cm2)

  3. 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

  4. To identify maternal factors affecting microbiota: antibiotics

    Time frame: pre-gestational

    antibiotics treatment during gestation (number of treatments)

  5. To identify the impact of mode of delivery

    Time frame: Birth

    Mode of delivery type: Vaginal/C-section (elective or non-elective)

  6. Infant weight

    Time frame: from birth to 24 month

    Infant weight (kg)

  7. Infant height

    Time frame: from birth to 24 month

    Infant height (cm)

  8. Infant Diet

    Time frame: from bith to 24 month

    Exclusive breastfeeding time (months), breastfeeding duration and time of introduction of complementary food

  9. 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

Sponsors and collaborators

Lead sponsor

Institute of Agrochemistry and Food Technology, National Research Council

Other Gov

Collaborators

  • CS La Eliana
  • CS Serreria II
  • 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

Registry information

Official study title

The Power of Maternal Microbes on Infant Health

Acronym: MAMI

Important dates

Study start
2015
Primary completion
2018
Study completion
2020
First posted
Jun 12, 2018
Registry last updated
Feb 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.