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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03552939
Recruitment Status : Active, not recruiting
First Posted : June 12, 2018
Last Update Posted : February 26, 2019
Sponsor:
Collaborators:
Fundación para la Investigación del Hospital Clínico de Valencia
Hospital Universitario La Fe
Hospital de Manises
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
CS Serreria II
CS La Eliana
Information provided by (Responsible Party):
Maria Carmen Collado, Institute of Agrochemistry and Food Technology, National Research Council

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

Condition or disease
Healthy

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.

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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Power of Maternal Microbes on Infant Health
Actual Study Start Date : June 2015
Actual Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2020



Primary Outcome Measures :
  1. Microbiota composition [ Time Frame: from birth to 24 month ]
    Dominant microbial species maternal and infant samples (using qPCR and sequencing -approaches analysis


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   women (pregnant women)
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Families located on the Mediterranean area
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03552939


Locations
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Spain
Fundacion Investigacion Sanitaria INCLIVA
Valencia, Spain
Hospital Universitario y Politecnico la Fe
Valencia, Spain
Sponsors and Collaborators
Institute of Agrochemistry and Food Technology, National Research Council
Fundación para la Investigación del Hospital Clínico de Valencia
Hospital Universitario La Fe
Hospital de Manises
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
CS Serreria II
CS La Eliana

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Maria Carmen Collado, Principal Investigator, Institute of Agrochemistry and Food Technology, National Research Council
ClinicalTrials.gov Identifier: NCT03552939    
Other Study ID Numbers: 639226
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maria Carmen Collado, Institute of Agrochemistry and Food Technology, National Research Council:
microbiota
breast milk
diet