The Impact of Maternal Microbes on Infant Health Programming

NCT03552939 | Completed

• 1 other identifier: 639226
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Healthy

Keywords

microbiota; breast milk; diet

Outcome Measures

Primary Outcomes (1)

• Microbiota composition

  Dominant microbial species maternal and infant samples (using qPCR and sequencing -approaches analysis

  from birth to 24 month

Secondary Outcomes (9)

• Maternal diet

  from birth to12 month

• Maternal BMI

  pre-gestational

• Maternal weight

  pre-gestational and from birth to 12 months post-partum

• To identify maternal factors affecting microbiota: antibiotics

  pre-gestational

• To identify the impact of mode of delivery

  Birth

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: women (pregnant women)
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Families located on the Mediterranean area

You may qualify if:

• Age\> 18 years.
• Healthy woman (no medication, no diabetes, no pre-gestational thyroid problems)
• Postpartum woman (beginning of the puerperium).

You may not qualify if:

• Medication and drugs
• Health problems at the immunological and metabolic levels.

Sponsors & Collaborators

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

Study Sites (2)

Fundacion Investigacion Sanitaria INCLIVA

Valencia, Spain

Location

Hospital Universitario y Politecnico la Fe

Valencia, Spain

Location

Related Publications (10)

• 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.

  PMID: 29026146 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.

  PMID: 28301837 RESULT

• 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.

  PMID: 27790209 RESULT

• 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.

  PMID: 27148183 RESULT

• Flores Ventura E, Bernabeu M, Callejon-Leblic B, Cabrera-Rubio R, Yeruva L, Estan-Capell J, Martinez-Costa C, Garcia-Barrera T, Collado MC. Human milk metals and metalloids shape infant microbiota. Food Funct. 2024 Dec 9;15(24):12134-12145. doi: 10.1039/d4fo01929f.

  PMID: 39584920 DERIVED

• Yeruva L, Mulakala BK, Rajasundaram D, Gonzalez S, Cabrera-Rubio R, Martinez-Costa C, Collado MC. Human milk miRNAs associate to maternal dietary nutrients, milk microbiota, infant gut microbiota and growth. Clin Nutr. 2023 Dec;42(12):2528-2539. doi: 10.1016/j.clnu.2023.10.011. Epub 2023 Oct 16.

  PMID: 37931372 DERIVED

• 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.

  PMID: 33228771 DERIVED

• 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.

  PMID: 33188413 DERIVED

• 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.

  PMID: 32728880 DERIVED

• 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.

  PMID: 31053102 DERIVED

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 21, 2018
• First Posted: June 12, 2018
• Study Start: June 1, 2015
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2020
• Last Updated: February 9, 2021

Record last verified: 2021-02

Locations

ES (2)