Condition category
Digestive System
Date applied
08/09/2008
Date assigned
06/10/2008
Last edited
25/08/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Rob te Biesebeke

ORCID ID

Contact details

Pieter Stuyvesantweg 1
Leeuwarden
8937 AC
Netherlands
+31 (0)61 250 4012
rob.tebiesebeke@frieslandfoods.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

IRCT010707

Study information

Scientific title

Microbiota diversity at the microbial species level of infant faecal samples in Europe, Asia, Mexico and Russia

Acronym

DIVERSITY

Study hypothesis

The faecal microflora of infants in different parts of the world have similarities despite individual variation.

Ethics approval

Not required from the International Medical Ethical Committee in Wageningen as of 30/09/2008.

Study design

Cross-sectional observational study

Primary study design

Observational

Secondary study design

Cross-section survey

Trial setting

Other

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Presence of pathogens or absence of "healthy" faecal microflora

Intervention

Health care staff from the Friesland Foods international network of medical specialists have agreed to participate in collecting faecal materials from Infants through their Health Care Practice. The Health Care professionals receive a reader with background information, protocols and a description of the study. Health Care professionals will be involved with coordination of sample collection and background information of the infants involved. Mothers will be asked to sign an informed consent, to collect and store faecal samples according to the sampling protocol. Samples will be transported to the Netherlands according to the sample transportation protocol. Deoxyribonucleic acid (DNA) will be extracted from the faecal samples according to the DNA extraction protocol and species will be identified and analysed according to the protocols.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Distribution of microbial species in faecal samples correlated to region.

Secondary outcome measures

Impact of geographic location on presence of microbial pathogens, and also bifidobacteria, lactobacilli, and other microbial species.

Overall trial start date

04/02/2006

Overall trial end date

01/12/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Healthy infants
2. Infants born through natural delivery
3. Informed consent
4. Infants from middle class parents
5. Exclusively formula-fed infants
6. Either male or female, aged 2 weeks up to ca. 12 months

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

300

Participant exclusion criteria

1. Allergic infants
2. Infants born through caesarean section

Recruitment start date

04/02/2006

Recruitment end date

01/12/2009

Locations

Countries of recruitment

France, Indonesia, Mexico, Netherlands, Russian Federation, Spain, Viet Nam

Trial participating centre

Pieter Stuyvesantweg 1
Leeuwarden
8937 AC
Netherlands

Sponsor information

Organisation

Royal Friesland Foods B.V. (Netherlands)

Sponsor details

c/o R. te Biesebeke
Pieter Stuyvesantweg 1
Leeuwarden
8937AC
Netherlands
+31 (0)61 250 4012
rob.tebiesebeke@frieslandfoods.com

Sponsor type

Industry

Website

http://www.frieslandfoods.com

Funders

Funder type

Industry

Funder name

Royal Friesland Foods B.V. (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