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

• ClinicalTrials.gov Identifier: NCT03552939
• Recruitment Status: Completed
• First Posted: June 12, 2018
• Last Update Posted: February 9, 2021
• Sponsor: Institute of Agrochemistry and Food Technology, National Research Council
• 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

Tracking Information

• First Submitted Date: March 21, 2018
• First Posted Date: June 12, 2018
• Last Update Posted Date: February 9, 2021
• Actual Study Start Date: June 2015
• Actual Primary Completion Date: December 31, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 10, 2018)

Microbiota composition [ Time Frame: from birth to 24 month ]

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 10, 2018)

• Maternal diet [ Time Frame: from birth to12 month ]
  Maternal diet (FFQ) during gestation and 12 month post-partum
• Maternal BMI [ Time Frame: pre-gestational ]
  To check Body Mass Index (kg/cm2)
• 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
• To identify maternal factors affecting microbiota: antibiotics [ Time Frame: pre-gestational ]
  antibiotics treatment during gestation (number of treatments)
• To identify the impact of mode of delivery [ Time Frame: Birth ]
  Mode of delivery type: Vaginal/C-section (elective or non-elective)
• Infant weight [ Time Frame: from birth to 24 month ]
  Infant weight (kg)
• Infant height [ Time Frame: from birth to 24 month ]
  Infant height (cm)
• Infant Diet [ Time Frame: from bith to 24 month ]
  Exclusive breastfeeding time (months), breastfeeding duration and time of introduction of complementary food
• 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Impact of Maternal Microbes on Infant Health Programming
• Official Title: The Power of Maternal Microbes on Infant Health
• 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.

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Probability Sample
• Study Population: Families located on the Mediterranean area
• Condition: Healthy
• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided

Publications *

• 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. Erratum In: Sci Rep. 2018 Nov 9;8(1):16829.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 10, 2018): 250
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: December 31, 2020
• Actual Primary Completion Date: December 31, 2018 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All
• Gender Based Eligibility: Yes
• Gender Eligibility Description: women (pregnant women)

• Ages: 18 Years to 40 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Spain

Administrative Information

• NCT Number: NCT03552939
• Other Study ID Numbers: 639226
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Maria Carmen Collado, Institute of Agrochemistry and Food Technology, National Research Council
• Original Responsible Party: Same as current
• Current Study Sponsor: Institute of Agrochemistry and Food Technology, National Research Council
• Original Study Sponsor: Same as current

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

• Investigators: Not Provided
• PRS Account: Institute of Agrochemistry and Food Technology, National Research Council
• Verification Date: February 2021