|
Welcome
|
|
30 July 2010
|
|
|
| home | my details | ISRCTN Register | mRCT | links | information | press |
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
| [ Print-friendly version ] |
| Study of pairs of neonate and mother for analysing intestinal microbiota as well as breast milk component |
| ISRCTN | ISRCTN66704989 |
| ClinicalTrials.gov identifier | |
| Public title | Study of pairs of neonate and mother for analysing intestinal microbiota as well as breast milk component |
| Scientific title | Observational single country multicentre study of pairs of neonate and mother for analysing intestinal microbiota as well as breast milk component |
| Acronym | N/A |
| Serial number at source | Yak.1.C.A. |
| Study hypothesis | The initial colonisation of the intestine of neonates is a gradual and dynamic process that is influenced by several factors such as genetic background of the host, mode of delivery, type of feeding and antibiotic therapy. Moreover, the colonisation succession process, both in timing and in composition may have a determinant effect on health later in life. Therefore, the purpose 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 multicentre observational trial |
| Countries of recruitment | Belgium |
| Disease/condition/study domain | Intestinal microbiota |
| Participants - 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 |
| Participants - 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) |
| Anticipated start date | 22/06/2009 |
| Anticipated end date | 01/11/2011 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 100 completed subjects |
| Interventions |
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.
Joint sponsor details: Danone Research BV (Netherlands) Bosrandweg 20 6704PH Wageningen Netherlands Email: rocio.martin@danone.com Tel: +31 (0) 317 467 886 Fax: +31 (0) 317 466 500 Website: http://www.danone.com |
| Primary outcome measure(s) |
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 measure(s) | No secondary outcome measures |
| Sources of funding |
1. Danone Research BV (Netherlands)
2. Yakult Honsha European Research (Belgium) |
| Trial website | |
| Publications | |
| Contact name | Dr Marijke De Decker |
| Address |
Research Unit Stuivenberg
Lange Beeldekensstraat 267 |
| City/town | Antwerpen |
| Zip/Postcode | 2060 |
| Country | Belgium |
| Sponsor | Yakult Honsha European Research (Belgium) |
| Address |
Yakult Honsha European Research Centre for Microbiology ESV
Technologiepark 4 bus 3 |
| City/town | Zwijnaarde |
| Zip/Postcode | 9052 |
| Country | Belgium |
| Sponsor website: | http://www.yakult.co.jp |
| Date applied | 30/10/2009 |
| Last edited | 17/12/2009 |
| Date ISRCTN assigned | 17/12/2009 |
|
|
|
|
|
| © 2010 ISRCTN unless otherwise stated. | |
|
|
|
|