Microbiota diversity of infant faecal samples in Europe, Asia, Mexico and Russia

ISRCTN	ISRCTN37114076
DOI	https://doi.org/10.1186/ISRCTN37114076
Secondary identifying numbers	IRCT010707

Submission date: 08/09/2008
Registration date: 06/10/2008
Last edited: 25/08/2011

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

Not provided at time of registration

Contact information

Dr Rob te Biesebeke
Scientific

Pieter Stuyvesantweg 1
Leeuwarden
8937 AC
Netherlands

Phone	+31 (0)61 250 4012
Email	rob.tebiesebeke@frieslandfoods.com

Study information

Study design	Cross-sectional observational study
Primary study design	Observational
Secondary study design	Cross-section survey
Study setting(s)	Other
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	Microbiota diversity at the microbial species level of infant faecal samples in Europe, Asia, Mexico and Russia
Study acronym	DIVERSITY
Study objectives	The faecal microflora of infants in different parts of the world have similarities despite individual variation.
Ethics approval(s)	Not required from the International Medical Ethical Committee in Wageningen as of 30/09/2008.
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	04/02/2006
Completion date	01/12/2009

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	2 Weeks
Upper age limit	12 Months
Sex	Both
Target number of participants	300
Key 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
Key exclusion criteria	1. Allergic infants 2. Infants born through caesarean section
Date of first enrolment	04/02/2006
Date of final enrolment	01/12/2009

Locations

Countries of recruitment

France
Indonesia
Mexico
Netherlands
Russian Federation
Spain
Viet Nam

Study participating centre

Pieter Stuyvesantweg 1

Leeuwarden
8937 AC
Netherlands

Sponsor information

Royal Friesland Foods B.V. (Netherlands)
Industry

c/o R. te Biesebeke
Pieter Stuyvesantweg 1
Leeuwarden
8937AC
Netherlands

Phone	+31 (0)61 250 4012
Email	rob.tebiesebeke@frieslandfoods.com
Website	http://www.frieslandfoods.com
"ROR"	https://ror.org/025mtxh67

Funders

Funder type

Industry

Royal Friesland Foods B.V. (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