Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Dr Steven Ramael
ORCID ID
Contact details
ZNA Stuivenberg
Lange Beeldekensstraat 267
Antwerpen
2060
Belgium
Type
Scientific
Additional contact
Dr Junji Fujimoto
ORCID ID
http://orcid.org/0000-0002-7009-4685
Contact details
Yakult Honsha European Research Center for Microbiology
ESV
Technologiepark 4
Gent-Zwijnaarde
9052
Belgium
+32 9 241 11 34
Junji.fujimoto@yher.be
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
YAK.2.C.A.
Study information
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
Acronym
Study hypothesis
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
Commissie voor Medische Ethiek-Ziekenhuis Nerwek Antwerpen, 07/04/2016
Study design
Single-centre observational trial
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet.
Condition
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
Phase
Drug names
Primary outcome measures
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)
Secondary outcome measures
No secondary outcome measures
Overall trial start date
15/11/2015
Overall trial end date
15/09/2016
Reason abandoned
Eligibility
Participant inclusion criteria
Male or female subjects aged between 4 and 7, who participated as a neonate in Study Yak.1.C.A.
Participant type
Healthy volunteer
Age group
Child
Gender
Both
Target number of participants
111 participants (maximum)
Participant 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
Recruitment start date
21/03/2016
Recruitment end date
31/07/2016
Locations
Countries of recruitment
Belgium
Trial participating centre
SGS LSS. Clinical pharmacology Unit Antwerpen
Lange Beeldekensstraat 267
Antwerpen
2060
Belgium
Sponsor information
Organisation
Yakult Honsha European Research Center
Sponsor details
Technologiepark 4
Gent-Zwijnaarde
9052
Belgium
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Yakult Honsha Co., Ltd.
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a peer reviewed journal.
Intention to publish date
30/09/2017
Participant level data
Stored in repository
Results - basic reporting
Publication summary