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The Impact of Maternal Microbes on Infant Health Programming

The Power of Maternal Microbes on Infant Health

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03552939
Acronym
MAMI
Enrollment
250
Registered
2018-06-12
Start date
2015-06-30
Completion date
2020-12-31
Last updated
2021-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

microbiota, breast milk, diet

Brief summary

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

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.

Interventions

None listed

Sponsors

Fundación para la Investigación del Hospital Clínico de Valencia
CollaboratorOTHER
Hospital Universitario La Fe
CollaboratorOTHER
Hospital de Manises
CollaboratorOTHER
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
CollaboratorOTHER
CS Serreria II
CollaboratorUNKNOWN
CS La Eliana
CollaboratorUNKNOWN
Institute of Agrochemistry and Food Technology, National Research Council
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Microbiota compositionfrom birth to 24 monthDominant microbial species maternal and infant samples (using qPCR and sequencing -approaches analysis

Secondary

MeasureTime frameDescription
Maternal BMIpre-gestationalTo check Body Mass Index (kg/cm2)
Maternal weightpre-gestational and from birth to 12 months post-partumTo check Weight gain over pregnancy (kg) and weight during lactation
To identify maternal factors affecting microbiota: antibioticspre-gestationalantibiotics treatment during gestation (number of treatments)
To identify the impact of mode of deliveryBirthMode of delivery type: Vaginal/C-section (elective or non-elective)
Maternal dietfrom birth to12 monthMaternal diet (FFQ) during gestation and 12 month post-partum
Infant heightfrom birth to 24 monthInfant height (cm)
Infant Dietfrom bith to 24 monthExclusive breastfeeding time (months), breastfeeding duration and time of introduction of complementary food
Fecal short-chain fatty acidsfrom birth to 24 monthDetermine the relationship between fecal microbiota composition and fecal short chain fatty acids
Infant weightfrom birth to 24 monthInfant weight (kg)

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026