Clinical trial NCT01894893: Atlas of Human Milk Nutrients
Official title: Atlas of Human Milk Nutrients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breastfeeding Mothers
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2013-07-10
Enrollment: 370
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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:

1. To assess whether there is a correlation between human milk composition and mothers' diet
2. To assess whether there is a correlation between human milk composition and maternal clinical parameters
3. To assess whether there is a correlation between human milk composition and mother and infant clinical parameters


Eligibility criteria: Inclusion Criteria:

* Between 18 and 40 years of age included at time of enrolment
* BMI before pregnancy between 19 and 29 included
* Having signed the Informed Consent Form
* Having decided to exclusively breast-feed until infant is 4 months old

Exclusion Criteria:

* Currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study
* Presenting any disease or medical condition which might prevent breast-feeding or collection the human milk samples or for which breast-feeding is not indicated
* Presenting diseases/medical conditions such as diabetes, heart problems, abnormal conditions of pregnancy (ex. hypertension)
* Presenting dietary problems/illnesses such as anorexia, bulimia and celiac disease
* Assuming any medication indicated for the treatment of any metabolic or cardiovascular disease
* Cannot be expected to comply with the study procedures

Primary outcomes:
measure: Characterization of human milk components
timeFrame: Between 0 and 4 months after delivery
Secondary outcomes:
measure: Human milk composition versus mothers' diet data
timeFrame: between 3 months before delivery and 4 months after delivery
measure: Human milk composition versus maternal clinical parameters
timeFrame: Between 0 and 4 months after delivery
measure: Human milk composition versus mother and infant clinical parameters
timeFrame: Between 0 and 4 months after delivery
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU Bordeaux
city: Lille
country: France
facility: CHRU de Lille
city: Lyon
country: France
facility: Hôpital de la Croix Rousse
city: Varese
country: Italy
facility: Ospedale del Ponte
city: Oslo
country: Norway
facility: Oslo University Hospital
city: Braga
country: Portugal
facility: Centro Hospitalar do Alto Ave Guimarães Hospital
city: Braga
country: Portugal
facility: Hospital de São Marcos
city: Porto
country: Portugal
facility: Hospital de S. João
city: Bucharest
country: Romania
facility: Al Jashi Isam Private Med. Practice
city: Bucharest
country: Romania
facility: Polizu Hospital
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
city: Stockholm
country: Sweden
facility: Department of Woman and Child Health, Karolinska University Hospital
city: Umea
country: Sweden
facility: Umeå University hospital
Study officials:
affiliation: University Hospital, Bordeaux
name: Claude Billeaud, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital de la Croix-Rousse
name: Jean-Charles Picaud, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: CHRU de Lille
name: Thameur Rakza, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Ospedale del Ponte Varese
name: Massimo Agosti, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Oslo University Hospital
name: Tom Stiris, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de S. João Porto
name: Silva Gorett, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de São Marcos - Braga
name: Almerinda Barroso Pereira, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Guimarães Hospital Braga
name: Maria Jose Costeira, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Al Jashi Isam Private Med. Practice Bucharest
name: Isam Al-Jashi, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Polizu Hospital Bucharest
name: Sylvia Stoicescu, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clínico Universitario de Valencia
name: Cecilia Martinez-Costa, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Umeå University
name: Magnus Domellöf,, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Karolinska University hospital in Solna
name: Mireille Vanpeé, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Karolinska University hospital in Solna
name: Giovanna Marchini, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.