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

ISRCTN	ISRCTN37114076
DOI	https://doi.org/10.1186/ISRCTN37114076
Protocol serial number	IRCT010707
Sponsor	Royal Friesland Foods B.V. (Netherlands)
Funder	Royal Friesland Foods B.V. (Netherlands)

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

Primary study design	Observational
Study design	Cross-sectional observational study
Secondary study design	Cross-section survey
Study type	Participant 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(s)	Distribution of microbial species in faecal samples correlated to region.
Key secondary outcome measure(s)	Impact of geographic location on presence of microbial pathogens, and also bifidobacteria, lactobacilli, and other microbial species.
Completion date	01/12/2009

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	2 Weeks
Upper age limit	12 Months
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes