YAK.1.C.A: The colonisation of the intestine in children

ISRCTN	ISRCTN66704989
DOI	https://doi.org/10.1186/ISRCTN66704989
Secondary identifying numbers	N/A

Submission date: 30/10/2009
Registration date: 17/12/2009
Last edited: 11/03/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Plain English summary under review

Contact information

Dr Marijke De Decker
Scientific

Research Unit Stuivenberg
Lange Beeldekensstraat 267
Antwerpen
2060
Belgium

Study information

Study design	Single country multi-centre cohort study
Primary study design	Observational
Secondary study design	Cohort study
Study setting(s)	Hospital
Study type	Screening
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Observational single country multi-centre study of pairs of neonate and mother for analysing intestinal microbiota as well as breast milk component
Study acronym	YAK.1.C.A
Study objectives	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(s)	Commissie voor Medische Ethiek-ZiekenhuisNerwek Antwerpen (ZNA), Insitutional Review Board-ZNA/OCMW Antwerpen approved on the 13th May 2009 (ref: 3388)
Health condition(s) or problem(s) studied	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
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 study start date	22/06/2009
Completion date	01/11/2011

Eligibility

Participant type(s)	Patient
Age group	Mixed
Sex	Both
Target number of participants	111 participants (maximum)
Key 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
Key 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)
Date of first enrolment	22/06/2009
Date of final enrolment	01/11/2011

Locations

Countries of recruitment

Belgium

Study participating centre

Research Unit Stuivenberg

Antwerp
2060
Belgium

Sponsor information

Yakult Honsha European Research Center
Industry

Technologiepark 4
Gent-Zwijnaarde
9052
Belgium

Website	http://www.yakult.co.jp
"ROR"	https://ror.org/03wmnrc91

Funders

Funder type

Industry

Danone Research BV (Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

11/03/2016: The follow up study is available at http://www.isrctn.com/ISRCTN25216339.