The Impact of Maternal Microbes on Infant Health Programming | NCT03552939

Studies
The Impact of Maternal Microbes on Infant Health Programming

NCT03552939

Sponsor

Institute of Agrochemistry and Food Technology, National Research Council

Status

Completed

Last Update Posted

Feb 9, 2021Actual

Enrollment

250Actual

Phase

Not provided

Conditions

Healthy

Interventions

Not provided

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2015Actual

Primary Completion Date

Dec 31, 2018Actual

Completion Date

Dec 31, 2020Actual

First Submitted Date

Mar 21, 2018

First Submission Date that Met QC Criteria

Jun 10, 2018

First Posted Date

Jun 12, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 8, 2021

Last Update Posted Date

Feb 9, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Maria Carmen Collado, Principal Investigator, Institute of Agrochemistry and Food Technology, National Research CouncilPrincipal Investigator

Lead Sponsor

Institute of Agrochemistry and Food Technology, National Research CouncilOTHER_GOV

Collaborators

Name	Class
Fundación para la Investigación del Hospital Clínico de Valencia	OTHER
Hospital Universitario La Fe	OTHER
Hospital de Manises	OTHER
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

250Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Maternal diet	Maternal diet (FFQ) during gestation and 12 month post-partum	from birth to12 month
Maternal BMI	To check Body Mass Index (kg/cm2)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Yes

Sex/Gender Description

women (pregnant women)

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Families located on the Mediterranean area

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fundacion Investigacion Sanitaria INCLIVA		Valencia			Spain
Hospital Universitario y Politecnico la Fe

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29026146	Result	Boix-Amoros A, Martinez-Costa C, Querol A, Collado MC, Mira A. Multiple Approaches Detect the Presence of Fungi in Human Breastmilk Samples from Healthy Mothers. Sci Rep. 2017 Oct 12;7(1):13016. doi: 10.1038/s41598-017-13270-x.
28301837	Result	Gomez-Gallego C, Kumar H, Garcia-Mantrana I, du Toit E, Suomela JP, Linderborg KM, Zhang Y, Isolauri E, Yang B, Salminen S, Collado MC. Breast Milk Polyamines and Microbiota Interactions: Impact of Mode of Delivery and Geographical Location. Ann Nutr Metab. 2017;70(3):184-190. doi: 10.1159/000457134. Epub 2017 Mar 17.