AzTrials
AzTrials

HealthyMAMINCT03552939

The Impact of Maternal Microbes on Infant Health Programming

An observational study of Healthy, run by Institute of Agrochemistry and Food Technology, National Research Council at 2 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

MAMI aims to characterize maternal microbes to be transferred to neonates and determine their function in infant health programming. Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
How many people
250 participants
Where
2 sitesSpain
Study dates
Jun 2015to 31 Dec 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Study population: Families located on the Mediterranean area

Who may be able to join

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

Who cannot join

  • Non-compliance with any of the inclusion criteria.
  • Medication and drugs
  • Health problems at the immunological and metabolic levels.

Trial locations and contacts

2 sites in 1 country.

Spain2 sites

  • Fundacion Investigacion Sanitaria INCLIVA

    Valencia

  • Hospital Universitario y Politecnico la Fe

    Valencia

Other trials in Spain

About this study

Official title: The Power of Maternal Microbes on Infant Health

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

Read the 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.

Conditions
Healthy
Keywords
microbiota, breast milk, diet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Microbiota composition

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

    Measured: from birth to 24 month

Secondary outcomes (9)

  1. Maternal diet

    Maternal diet (FFQ) during gestation and 12 month post-partum

    Measured: from birth to12 month

  2. Maternal BMI

    To check Body Mass Index (kg/cm2)

    Measured: pre-gestational

  3. Maternal weight

    To check Weight gain over pregnancy (kg) and weight during lactation

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

  4. To identify maternal factors affecting microbiota: antibiotics

    antibiotics treatment during gestation (number of treatments)

    Measured: pre-gestational

  5. To identify the impact of mode of delivery

    Mode of delivery type: Vaginal/C-section (elective or non-elective)

    Measured: Birth

  6. Infant weight

    Infant weight (kg)

    Measured: from birth to 24 month

  7. Infant height

    Infant height (cm)

    Measured: from birth to 24 month

  8. Infant Diet

    Exclusive breastfeeding time (months), breastfeeding duration and time of introduction of complementary food

    Measured: from bith to 24 month

  9. Fecal short-chain fatty acids

    Determine the relationship between fecal microbiota composition and fecal short chain fatty acids

    Measured: from birth to 24 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2018
  2. Study startJun 2015
  3. Primary completion31 Dec 2018
  4. Study completion31 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
250 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03552939
Sponsor's protocol ID
639226
Acronym
MAMI
Status last verified
Feb 2021
First submitted
21 Mar 2018
Last updated
9 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 29026146

  • 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.

    PubMed 28301837

  • 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.

    PubMed 27790209

  • 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.

    PubMed 27148183

  • Ventura EF, Ruiz-Saavedra S, Cabrera-Rubio R, Martinez-Costa C, Gonzalez S, Collado MC. Novel insights into how gestational diet affects maternal-infant microbiota: a cross-sectional causal mediation analysis at one month postpartum. Eur J Nutr. 2026 Mar 9;65(3):87. doi: 10.1007/s00394-026-03909-9.

    PubMed 41801411

  • 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.

    PubMed 39584920

  • 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.

    PubMed 37931372

  • 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.

    PubMed 33228771

  • 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.

    PubMed 33188413

  • 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.

    PubMed 32728880

  • 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.

    PubMed 31053102

Questions about this trial

What is this clinical trial studying?

An observational study of Healthy, run by Institute of Agrochemistry and Food Technology, National Research Council at 2 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Microbiota composition (time frame: from birth to 24 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03552939, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2021.

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