Clinical trial NCT03552939: The Impact of Maternal Microbes on Infant Health Programming
Official title: The Power of Maternal Microbes on Infant Health
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: microbiota
breast milk
diet
Lead sponsor: Institute of Agrochemistry and Food Technology, National Research Council
Sponsor class: OTHER_GOV
Collaborators: name: Fundación para la Investigación del Hospital Clínico de Valencia
name: Hospital Universitario La Fe
name: Hospital de Manises
name: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
name: CS Serreria II
name: CS La Eliana
First posted: 2018-06-12
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Families located on the Mediterranean area

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.

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.

Primary outcomes:
measure: Microbiota composition
timeFrame: from birth to 24 month
Secondary outcomes:
measure: Maternal diet
timeFrame: from birth to12 month
measure: Maternal BMI
timeFrame: pre-gestational
measure: Maternal weight
timeFrame: pre-gestational and from birth to 12 months post-partum
measure: To identify maternal factors affecting microbiota: antibiotics
timeFrame: pre-gestational
measure: To identify the impact of mode of delivery
timeFrame: Birth
measure: Infant weight
timeFrame: from birth to 24 month
measure: Infant height
timeFrame: from birth to 24 month
measure: Infant Diet
timeFrame: from bith to 24 month
measure: Fecal short-chain fatty acids
timeFrame: from birth to 24 month
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Fundacion Investigacion Sanitaria INCLIVA
city: Valencia
country: Spain
facility: Hospital Universitario y Politecnico la Fe
Study officials:
References:
citation: 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.
citation: 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.
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;7:1619. doi: 10.3389/fmicb.2016.01619. eCollection 2016.
citation: Boix-Amoros 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.
citation: Selma-Royo M, Calatayud Arroyo M, Garcia-Mantrana I, Parra-Llorca A, Escuriet R, Martinez-Costa C, Collado MC. Perinatal environment shapes microbiota colonization and infant growth: impact on host response and intestinal function. Microbiome. 2020 Nov 23;8(1):167. doi: 10.1186/s40168-020-00940-8.
citation: Cortes-Macias E, Selma-Royo M, Garcia-Mantrana I, Calatayud M, Gonzalez S, Martinez-Costa C, Collado MC. Maternal Diet Shapes the Breast Milk Microbiota Composition and Diversity: Impact of Mode of Delivery and Antibiotic Exposure. J Nutr. 2021 Feb 1;151(2):330-340. doi: 10.1093/jn/nxaa310.
citation: Selma-Royo M, Garcia-Mantrana I, Calatayud M, Parra-Llorca A, Martinez-Costa C, Collado MC. Maternal diet during pregnancy and intestinal markers are associated with early gut microbiota. Eur J Nutr. 2021 Apr;60(3):1429-1442. doi: 10.1007/s00394-020-02337-7. Epub 2020 Jul 29.
citation: Garcia-Mantrana I, Alcantara C, Selma-Royo M, Boix-Amoros A, Dzidic M, Gimeno-Alcaniz J, Ubeda-Sansano I, Sorribes-Monrabal I, Escuriet R, Gil-Raga F, Parra-Llorca A, Martinez-Costa C, Collado MC; MAMI team. MAMI: a birth cohort focused on maternal-infant microbiota during early life. BMC Pediatr. 2019 May 3;19(1):140. doi: 10.1186/s12887-019-1502-y.