OverweightFITCHINCT03196453
Fit Child - Clinical Study on Weight Control
A study testing Probiotic in people with Overweight and Nutrition Disorder, Child, run by Turku University Hospital at 1 site in Finland.
Trial summary
Children with abnormal weight development of BMI will be given either placebo or a probiotic protein formula and measures of weigh gain during a 3-mont treatment will be conducted Read more about this study
- Who is it for?
- Ages 2 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Nutrition Disorder, Child, Weight Change, Body
- What is being tested?
- Probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteFinland
- Study dates
- 25 May 2018to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Inclusion Criteria: 2-5 year old child with early weight gain and abnormal BMI, parental concern on weight gain/development
-
Exclusion Criteria:Medicines influencing gastric or intestinal function, antibiotic treatment during the last 6 months, use of specific probiotics
Trial locations and contacts
1 site in 1 country.
Finland1 site
University of Turku and University Hospital Turku
Turku, Varsinaissuomi, 20520
About this study
Official title: Sopusuhtainen Lapsi - Kliininen Tutkimus Painonhallinnasta
Children with abnormal weight development of BMI will be given either placebo or a probiotic protein formula and measures of weigh gain during a 3-mont treatment will be conducted
Read the detailed description
In this study, children with abnormal weight development of BMI will be recruited and the gut microbiota will be modified using one of there treatment schedules. The subjects will be divided into three groups 1) receiving a daily drink with protein drink with a probiotic Lactobacillus rhamnosus GG or 2) placebo drink and/or 3) drink with Lactobacillus rhamnosus GG.
The children will give a faecal sample in the beginning and at the end and similarly also a blood sample. The faecal sample will be used for analysis of microbiota and differences in microbiota between the groups. Blood samples will be analysed for obesity related biomarkers.
Body weight is followed at home and at frequent intervals of the study and analyses made for overweight related biomarkers.
- Conditions
- Overweight, Nutrition Disorder, Child, Weight Change, Body
- Being tested
- Probiotic
- Keywords
- overweight, probiotic, weight management
- Medical subject headings
- Overweight, Child Nutrition Disorders, Body Weight Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
Also called FITCHI (Fit Child)
probiotic and/or placebo intervention in toddlers
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Active comparator | Lactobacillus rhamnosus GG Receives: Dietary Supplement: Probiotic |
| Probiotic and protein | Active comparator | Lactobacillus rhamnosus GG and whey protein isolate Receives: Dietary Supplement: Probiotic |
| Placebo | Placebo comparator | Placebo Receives: Dietary Supplement: Probiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight gain
body weight
Measured: 3 months
Secondary outcomes (2)
Blood biomarkers
Subar
Measured: 3 months
Weight change
Weight change
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2017
- Study start25 May 2018 (estimated)
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Why it stopped: The study protocol has been applied in a new study, after te COVID. New registration.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- double blind, placebo controlled,
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Collaborators
- University of Turku
- Responsible party
- Principal investigator, Erika Isolauri, Turku University Hospital
- Investigators
- Erika Isolauri, Principal investigator, University of Turku, Department of Pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03196453
- Sponsor's protocol ID
- T6161/2017
- Acronym
- FITCHI
- Status last verified
- Jun 2017
- First submitted
- 20 Jun 2017
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be shared once the study has been completed and analysed
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sopusuhtainen Lapsi - Kliininen Tutkimus Painonhallinnasta
- ClinicalTrials.gov ID
- NCT03196453
- Acronym / sponsor ID
- FITCHI / T6161/2017
- Conditions
- Overweight, Nutrition Disorder, Child, Weight Change, Body
- Keywords
- overweight, probiotic, weight management
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study protocol has been applied in a new study, after te COVID. New registration.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Collaborators
- University of Turku
- Study start
- 25 May 2018 (estimated)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 22 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Children with abnormal weight development of BMI will be given either placebo or a probiotic protein formula and measures of weigh gain during a 3-mont treatment will be conducted
Detailed description
In this study, children with abnormal weight development of BMI will be recruited and the gut microbiota will be modified using one of there treatment schedules. The subjects will be divided into three groups 1) receiving a daily drink with protein drink with a probiotic Lactobacillus rhamnosus GG or 2) placebo drink and/or 3) drink with Lactobacillus rhamnosus GG.
The children will give a faecal sample in the beginning and at the end and similarly also a blood sample. The faecal sample will be used for analysis of microbiota and differences in microbiota between the groups. Blood samples will be analysed for obesity related biomarkers.
Body weight is followed at home and at frequent intervals of the study and analyses made for overweight related biomarkers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- double blind, placebo controlled,
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Active comparator | Dietary Supplement: ProbioticLactobacillus rhamnosus GG |
| Probiotic and protein | Active comparator | Dietary Supplement: ProbioticLactobacillus rhamnosus GG and whey protein isolate |
| Placebo | Placebo comparator | Dietary Supplement: ProbioticPlacebo |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbioticAlso: FITCHI (Fit Child)probiotic and/or placebo intervention in toddlers | Dietary supplement | Placebo, Probiotic, Probiotic and protein |
Primary outcome
weight gain
Time frame: 3 months
body weight
2 secondary outcomes
Blood biomarkers
Time frame: 3 months
Weight change
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Individual participant dataSharing planned: No. IPD will be shared once the study has been completed and analysed
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erika Isolauri principal investigator
University of Turku, Department of Pediatrics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic in people with Overweight and Nutrition Disorder, Child, run by Turku University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weight gain (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.