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The main objective of this clinical trial is to collect human milk samples from 0 to 4 months after delivery in order to characterize human milk components. The secondary objectives of this study are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breastfeeding mothers |
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| Measure | Description | Time Frame |
|---|---|---|
| Characterization of human milk components | Nutrients in human breast milk samples will be characterized and quantified by analysing with modern analytical techniques (NMR, HPLC-MS and GC-MS) the human milk samples collected at each study visits (3d, 14 days, 1m, 2m, 3m and 4 months after delivery, 1 week after delivery, ). The parameters which will be assessed in human milk samples are : Total Energy Value, Total Macronutrients (lipids, proteins, carbohydrates, solids), Lipids' characterization, Peptide profiling, Oligosaccharides profiling, and Micro-RNA profiling. It will be done in 240 completed mothers. | Between 0 and 4 months after delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Human milk composition versus mothers' diet data | The human milk composition profiles (primary outcome) will be correlated in a longitudinal manner to mothers' diet. Information on mother's diet will be collected using a 3-days diary and entering the data in Nutrilog (total intake of the mothers). This will be done before each study visit in 240 completed mothers. | between 3 months before delivery and 4 months after delivery |
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Inclusion Criteria:
Exclusion Criteria:
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Healthy mothers of any ethnicity having decided to exclusively breast-feed their new born baby from birth up to 4 months of age will be eligible to participate in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Claude Billeaud, Prof | University Hospital, Bordeaux | Principal Investigator |
| Jean-Charles Picaud, Prof | Hôpital de la Croix-Rousse | Principal Investigator |
| Thameur Rakza, Dr | CHRU de Lille | Principal Investigator |
| Massimo Agosti, Dr | Ospedale del Ponte Varese | Principal Investigator |
| Tom Stiris, Dr | Oslo University Hospital | Principal Investigator |
| Silva Gorett, Dr | Hospital de S. João Porto | Principal Investigator |
| Almerinda Barroso Pereira, Dr | Hospital de São Marcos - Braga | Principal Investigator |
| Maria Jose Costeira, Dr | Guimarães Hospital Braga | Principal Investigator |
| Isam Al-Jashi, Dr | Al Jashi Isam Private Med. Practice Bucharest | Principal Investigator |
| Sylvia Stoicescu, Dr |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Bordeaux | Bordeaux | France | ||||
| CHRU de Lille |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34510208 | Derived | Raymond F, Lefebvre G, Texari L, Pruvost S, Metairon S, Cottenet G, Zollinger A, Mateescu B, Billeaud C, Picaud JC, Silva-Zolezzi I, Descombes P, Bosco N. Longitudinal Human Milk miRNA Composition over the First 3 mo of Lactation in a Cohort of Healthy Mothers Delivering Term Infants. J Nutr. 2022 Jan 11;152(1):94-106. doi: 10.1093/jn/nxab282. | |
| 33446921 |
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| Human milk composition versus maternal clinical parameters | The human milk composition profiles will be correlated in a longitudinal manner to the stage of lactation, the gestation's age, the type of delivery, the sex of the baby, the number of babies the mother already had (gravidity and parity), single/multiple birth. It will be done in 240 completed mothers. | Between 0 and 4 months after delivery |
| Human milk composition versus mother and infant clinical parameters | The human milk composition profiles will be correlated in a longitudinal manner to infant anthropometric measurements (weight, height and head circumference). It will be done in 240 completed mothers. | Between 0 and 4 months after delivery |
| Polizu Hospital Bucharest |
| Principal Investigator |
| Cecilia Martinez-Costa, Dr | Hospital Clínico Universitario de Valencia | Principal Investigator |
| Magnus Domellöf,, Dr | Umeå University | Principal Investigator |
| Mireille Vanpeé, Dr | Karolinska University hospital in Solna | Principal Investigator |
| Giovanna Marchini, Dr | Karolinska University hospital in Solna | Principal Investigator |
| Lille |
| France |
| Hôpital de la Croix Rousse | Lyon | France |
| Ospedale del Ponte | Varese | Italy |
| Oslo University Hospital | Oslo | Norway |
| Centro Hospitalar do Alto Ave Guimarães Hospital | Braga | Portugal |
| Hospital de São Marcos | Braga | Portugal |
| Hospital de S. João | Porto | Portugal |
| Al Jashi Isam Private Med. Practice | Bucharest | Romania |
| Polizu Hospital | Bucharest | Romania |
| Hospital Clínico Universitario de Valencia | Valencia | Spain |
| Department of Woman and Child Health, Karolinska University Hospital | Stockholm | Stockholm County | 171 76 | Sweden |
| Umeå University hospital | Umeå | Sweden |
| Binia A, Lavalle L, Chen C, Austin S, Agosti M, Al-Jashi I, Pereira AB, Costeira MJ, Silva MG, Marchini G, Martinez-Costa C, Stiris T, Stoicescu SM, Vanpee M, Rakza T, Billeaud C, Picaud JC, Domellof M, Adams R, Castaneda-Gutierrez E, Sprenger N. Human milk oligosaccharides, infant growth, and adiposity over the first 4 months of lactation. Pediatr Res. 2021 Sep;90(3):684-693. doi: 10.1038/s41390-020-01328-y. Epub 2021 Jan 14. |