The Impact of Maternal Microbes on Infant Health Programming

Healthy Clinical Trial

— MAMI  

Official title:

The Power of Maternal Microbes on Infant Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03552939
• Other study ID #: 639226
• Status: Completed
• Start date: June 2015
• Est. completion date: December 31, 2020

Study information

• Verified date: February 2021
• Source: Institute of Agrochemistry and Food Technology, National Research Council
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Locations

Country	Name	City	State
Spain	Fundacion Investigacion Sanitaria INCLIVA	Valencia
Spain	Hospital Universitario y Politecnico la Fe	Valencia

Sponsors (7)

Lead Sponsor	Collaborator
Institute of Agrochemistry and Food Technology, National Research Council	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 de Manises, Hospital Universitario La Fe

Country where clinical trial is conducted

Spain, 

References & Publications (4)

Boix-Amorós A, Collado MC, Mira A. Relationship between Milk Microbiota, Bacterial Load, Macronutrients, and Human Cells during Lactation. Front Microbiol. 2016 Apr 20;7:492. doi: 10.3389/fmicb.2016.00492. eCollection 2016. — View Citation

Boix-Amorós 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. Erratum in: Sci Rep. 2018 N — View Citation

Gómez-Gallego C, Kumar H, García-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 Meta — View Citation

Kumar H, du Toit E, Kulkarni A, Aakko J, Linderborg KM, Zhang Y, Nicol MP, Isolauri E, Yang B, Collado MC, Salminen S. Distinct Patterns in Human Milk Microbiota and Fatty Acid Profiles Across Specific Geographic Locations. Front Microbiol. 2016 Oct 13;7: — View Citation

Outcome

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