Investigation on the impact of continuous colonization of Bifidobacteria during early life on child’s health

ISRCTN	ISRCTN25216339
DOI	https://doi.org/10.1186/ISRCTN25216339
Protocol serial number	YAK.2.C.A.
Sponsor	Yakult Honsha European Research Center
Funder	Yakult Honsha Co., Ltd.

Submission date: 08/03/2016
Registration date: 11/03/2016
Last edited: 19/08/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
The human gut plays host to tens of trillions of different bacteria, which are known as the “gut flora”. The bacteria present in the gut flora are often referred to as “good” or “friendly” bacteria, because they assist in digestion and help to produce important vitamins for the body. One of the most common groups of bacteria that live in the gut is bifidobacteria, also known as lactic acid bacteria. Having the right levels and a good variety of gut bacteria is important for healthy development in children and good general health. It is thought that the colonization of the gut with different types of bacteria begins early in life, and can be affected by their inherited characteristics (genetic profile), how they are born (natural delivery or caesarian section) and whether they are breast fed. An initial study looked at the development of bacterial colonization in the gut by assesseing faecal samples (excrement), and the components of breast milk to see if it plays a role. This follow up study is conducted when the child is aged between 4 and 7 years old aims to look at the colonization of the gut (particularly the bifidobacteria) in childhood, and whether it has an effect on the child’s health.

Who can participate?
Children aged between 4 and 7 who took part in the initial study as a baby.

What does the study involve?
The parent/guardian of the child completes a number of questionnaires about their child’s health and disease history and the child is observed by a researcher in order to assess their personality. The child also provides two faeces samples 7-9 days apart so that the levels of bacteria present in their gut, particularly bifidobacteria, can be measured.

What are the possible benefits and risks of participating?
There are no anticipated benefits or risks for participants involves in this study.

Where is the study run from?
Research Unit Stuivenberg (Belgium)

When is the study starting and how long is it expected to run for?
November 2015 to September 2016

Who is funding the study?
Yakult Honsha European Research (Belgium)

Who is the main contact?
1. Dr Steven Ramael (scientific)
2. Dr Junji Fujimoto (scientific)
Junji.fujimoto@yher.be

Contact information

Dr Steven Ramael
Scientific

ZNA Stuivenberg
Lange Beeldekensstraat 267
Antwerpen
2060
Belgium

Dr Junji Fujimoto
Scientific

Yakult Honsha European Research Center for Microbiology, ESV
Technologiepark 4
Gent-Zwijnaarde
9052
Belgium

ORCID ID	0000-0002-7009-4685
Phone	+32 9 241 11 34
Email	Junji.fujimoto@yher.be

Study information

Primary study design	Observational
Study design	Single-centre observational trial
Secondary study design	Cohort study
Study type	Participant information sheet
Scientific title	The Follow-up Study of YAK.1.C.A: Investigation on the impact of continuous colonization of Bifidobacteria during early life on child’s health
Study objectives	The aim of this study is to investigate if the presence of bifidobacteria during early life, analyzed in Study Yak.1.C.A., and its persistence impact on child’s health and personality.
Ethics approval(s)	Commissie voor Medische Ethiek-Ziekenhuis Nerwek Antwerpen, 07/04/2016
Health condition(s) or problem(s) studied	Intestinal microbiota
Intervention	Legally acceptable representative will fill out questionnaires regarding the subject’s disease history and demographic as well as the Children’s Behaviour Questionnaire in order to examine their personality. Two faecal samples for each subject will be collected with an interval of 7 to 9 days for microbiological analysis.
Intervention type	Not Specified
Primary outcome measure(s)	The study consists of “Screening day (S)”, “First faecal delivery day (F1: within 28 days after Screening day)” and “Second faecal delivery day (F2: within 7 to 9 days after F1)”. Subjects will not be allowed to drink fermented milk between F1 and F2 1. Subject’s disease history will be collected by questionnaire on F1, and additionally on F2 in order to follow the disease occurrence in the interval 2. Subject’s demographics will be collected by questionnaire on S, and additionally on F1 and F2 in order to follow the status of fermented milk and intestinal drugs (e.g. antibiotics) ingestion in the intervals 3. Children’s personality will be assessed based on Children’s Behavior Questionnaire collected on F1 4. Faecal microbial composition, diversity and the absolute number of specific bacteria will be analyzed by 16S rRNA metagenomics or quantitative polymerase chain reaction (PCR) targeting bacterial DNA extracted from the faeces collected on F1 and F2. Preserved bacterial DNA from Study YAK.1.C.A. will also be analyzed. 5. Persistence of bifidobacteria from early life will be evaluated by comparing the homogeneity of bifidobacterial strains isolated from faeces collected on F2 to those isolated in Study YAK.1. C.A. by using multilocus sequence typing (MLST)
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	15/09/2016

Eligibility

Participant type(s)	Healthy volunteer
Age group	Child
Lower age limit	4 Years
Upper age limit	7 Years
Sex	All
Target sample size at registration	111
Total final enrolment	49
Key inclusion criteria	Male or female subjects aged between 4 and 7, who participated as a neonate in Study Yak.1.C.A.
Key exclusion criteria	1. Participation in another clinical study during the study or within 30 days prior to entry in this study 2. A condition that, in the opinion of the Investigator, could compromise the well-being of the subject or course of the study, or prevent the subject from meeting or performing any study requirements
Date of first enrolment	21/03/2016
Date of final enrolment	31/07/2016

Locations

Countries of recruitment

Belgium

Study participating centre

SGS LSS. Clinical pharmacology Unit Antwerpen

Lange Beeldekensstraat 267
Antwerpen
2060
Belgium

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Stored in repository
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	12/12/2018	19/08/2019	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

19/08/2019: Publication reference and total final enrolment added.
13/04/2016: Ethics approval information added.

This study is a follow up of the YAK.1.C.A study, available at http://www.isrctn.com/ISRCTN66704989.