Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Observational single country multi-centre study of pairs of neonate and mother for analysing intestinal microbiota as well as breast milk component
Acronym
YAK.1.C.A
Study hypothesis
The aim of this study is to better understand how the initial colonisation of the gut occurs, which will allow a better design of new generation nutritional concepts for infants.
Ethics approval
Commissie voor Medische Ethiek-ZiekenhuisNerwek Antwerpen (ZNA), Insitutional Review Board-ZNA/OCMW Antwerpen approved on the 13th May 2009 (ref: 3388)
Study design
Single country multi-centre cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Intestinal microbiota
Intervention
The subjects will be selected by SGS LIFE SCIENCE SERVICES, under the supervision of the principal investigator. The principal investigator and his/her study team will cooperate with gynaecologists and midwifes for the first contact with subjects. Those healthy pregnant women who agree to participate, will be included during the last 2 months of pregnancy and their newborns will be followed for 6 months. Participants will be asked to sign an informed consent, to fill in a diary and to collect faecal and breast milk samples according to the sampling protocol. For the participants the study will last at least 7 months and consists of one hospital visit and seven phone calls.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. Faecal microbiota composition of the mothers and neonates. The faecal microbiota composition of the mother will be measured 2 times (with one week interval) between 1 and 2 months before the delivery. The faecal microbiota composition of the neonates will be measured in the first faecal sample of the neonates and two days later, and at one week, one month, 3 months and 6 months of life. If the baby starts with weaning food during the study period, 1 faecal sample needs to be collected 1 week after start of weaning.
2. Faecal short chain fatty acids (SCFA) and faecal lactate, measured at the same timepoints as that of the faecal microbiota
3. Microbiota composition of the breast milk. The microbiota composition of the breast milk will be measured before delivery when possible, and after delivery (colostrums) if possible, at 1 week and 1 month after delivery.
4. Oligosaccharides quantification in breast milk, measured at the same timepoints as that of the breast milk microbiota
5. Lipid quantification in breast milk, measured at the same timepoints as that of the breast milk microbiota
6. Protein quantification in breast milk, measured at the same timepoints as that of the breast milk microbiota
Secondary outcome measures
No secondary outcome measures
Overall trial start date
22/06/2009
Overall trial end date
01/11/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Healthy pregnant female at 24 weeks of pregnancy
2. Normal course of pregnancy
3. Written Informed Consent dated and signed by the mother
4. Good physical and mental health status as determined by medical history and general clinical examination according to the investigators judgment
5. Considered as reliable and capable of adhering to the protocol, according to the investigator
Participant type
Patient
Age group
Mixed
Gender
Both
Target number of participants
111 participants (maximum)
Participant exclusion criteria
1. Birth in water
2. Participation in another clinical trial during the study or within 60 days before delivery
3. Alcohol consumption of more than 7 units per week (1 unit being a glass of beer, wine or a measure of spirits)
4. Reported current usage of illegal drugs
After delivery:
1. Prematurely-born neonate (before 37 weeks of pregnancy)
2. In case a subject has decided to resign from further participation in the study
3. In case a subject suffers from a bacterial/viral infection within 2 weeks before delivery
4. In case a subject delivers a baby with major congenial malformation(s)
5. In case the subject and/or the baby use immunomodulatory drugs between 4 weeks prior to delivery and the end of the study (6 months after delivery)
6. In case the subject and/or the baby use antibiotics between 2 weeks prior to delivery and 2 weeks after the delivery, for any reason except for a prophylactic use (e.g. caesarean section)
Recruitment start date
22/06/2009
Recruitment end date
01/11/2011
Locations
Countries of recruitment
Belgium
Trial participating centre
Research Unit Stuivenberg
Antwerp
2060
Belgium
Sponsor information
Organisation
Yakult Honsha European Research Center
Sponsor details
Technologiepark 4
Gent-Zwijnaarde
9052
Belgium
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Danone Research BV (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list