Condition category
Digestive System
Date applied
30/10/2009
Date assigned
17/12/2009
Last edited
11/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Plain English summary under review

Trial website

Contact information

Type

Scientific

Primary contact

Dr Marijke De Decker

ORCID ID

Contact details

Research Unit Stuivenberg
Lange Beeldekensstraat 267
Antwerpen
2060
Belgium

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 measures

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

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

http://www.yakult.co.jp

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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