Healthy Clinical Trial
— MAMIOfficial title:
The Power of Maternal Microbes on Infant Health
NCT number | NCT03552939 |
Other study ID # | 639226 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 2015 |
Est. completion date | December 31, 2020 |
MAMI aims to characterize maternal microbes to be transferred to neonates and determine their function in infant health programming.
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. |
Country | Name | City | State |
---|---|---|---|
Spain | Fundacion Investigacion Sanitaria INCLIVA | Valencia | |
Spain | Hospital Universitario y Politecnico la Fe | Valencia |
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 |
Spain,
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
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 |
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