Emotional RegulationNCT06258135
At Home Placebo-controlled 8-week GOS Intervention on Emotion Behaviour and Cognition in Children (Age 6-14 Years).
A study testing Galacto-oligosaccharide and Maltodextrin in people with Emotional Regulation, run by University of Surrey at 1 site in United Kingdom.
Trial summary
This study aims to investigate how GOS food supplement influences the gut-microbiome-brain axis to improve emotion regulation skills and cognition in a sample of children and adolescents (aged 6-14 years). Read more about this study
- Who is it for?
- Ages 6 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Emotional Regulation
- What is being tested?
- Galacto-oligosaccharide and Maltodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Feb 2021to 1 Mar 2022
- 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 6 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Typically developing, healthy male or female aged 6-14 years
- Access to home laptop/ personal computer
Who cannot join
- Current clinical levels of anxiety and/or co-morbid psychological diagnoses
- Neuro/developmental disorders
- Gastro-intestinal problems or disease
- Restrictive diets (e.g., lactose intolerance, gluten free)
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to investigate how GOS food supplement influences the gut-microbiome-brain axis to improve emotion regulation skills and cognition in a sample of children and adolescents (aged 6-14 years).
- Conditions
- Emotional Regulation
- Being tested
- Galacto-oligosaccharide, Maltodextrin
- Medical subject headings
- Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Galacto-oligosaccharideDietary supplement
Single 7g dose daily for 28 days
MaltodextrinDietary supplement
Single 7g dose daily for 28 days
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Active comparator | Not described Receives: Dietary Supplement: Galacto-oligosaccharide |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in trait anxiety.
Self report instrument: state-trait anxiety measure for children (STAIC) - Trait scale.
Measured: End of treatment (4 weeks), Follow up (8 weeks).
Changes in emotion processing.
Performance on behavioural task: emotional dot-probe task.
Measured: End of treatment (4 weeks), Follow up (8 weeks).
Secondary outcomes (3)
Changes in depression.
Self report instrument: child depression inventory (CDI).
Measured: End of treatment (4 weeks), Follow up (8 weeks).
Changes in attention networks.
Performance on behavioural task: attention network test (ANT) adapted for use by children.
Measured: End of treatment (4 weeks), Follow up (8 weeks).
Changes in nutrient intake
Self report instrument: food diary completed over 4 days, average intakes calculated.
Measured: End of treatment (4 weeks), Follow up (8 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start1 Feb 2021
- Primary completion1 Dec 2021
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Emotional RegulationStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Surrey
- Sponsor type
- University, hospital or other
- Collaborators
- FrieslandCampina
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06258135
- Sponsor's protocol ID
- FearlessStudy4
- Status last verified
- Feb 2024
- First submitted
- 6 Feb 2024
- Last updated
- 14 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Johnstone N, Cohen Kadosh K. Indicators of improved emotion behavior in 6-14-year-old children following a 4-week placebo controlled prebiotic supplement intervention at home with a parent. Nutr J. 2025 Mar 1;24(1):34. doi: 10.1186/s12937-025-01098-5.
PubMed 40025494
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- At Home Placebo-controlled 8-week GOS Intervention on Emotion Behaviour and Cognition in Children (Age 6-14 Years).
- ClinicalTrials.gov ID
- NCT06258135
- Acronym / sponsor ID
- FearlessStudy4
- Conditions
- Emotional Regulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University of SurreyUniversity, hospital or other
- Collaborators
- FrieslandCampina
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 14 Feb 2024 (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.
This study aims to investigate how GOS food supplement influences the gut-microbiome-brain axis to improve emotion regulation skills and cognition in a sample of children and adolescents (aged 6-14 years).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Active comparator | Dietary Supplement: Galacto-oligosaccharide |
| Placebo | Placebo comparator | Dietary Supplement: Maltodextrin |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Typically developing, healthy male or female aged 6-14 years
- Access to home laptop/ personal computer
Key exclusion criteria (4 listed)
- Current clinical levels of anxiety and/or co-morbid psychological diagnoses
- Neuro/developmental disorders
- Gastro-intestinal problems or disease
- Restrictive diets (e.g., lactose intolerance, gluten free)
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 |
|---|---|---|
| Galacto-oligosaccharideSingle 7g dose daily for 28 days | Dietary supplement | Treatment |
| MaltodextrinSingle 7g dose daily for 28 days | Dietary supplement | Placebo |
Primary outcome
Changes in trait anxiety.
Time frame: End of treatment (4 weeks), Follow up (8 weeks).
Self report instrument: state-trait anxiety measure for children (STAIC) - Trait scale.
Changes in emotion processing.
Time frame: End of treatment (4 weeks), Follow up (8 weeks).
Performance on behavioural task: emotional dot-probe task.
3 secondary outcomes
Changes in depression.
Time frame: End of treatment (4 weeks), Follow up (8 weeks).
Changes in attention networks.
Time frame: End of treatment (4 weeks), Follow up (8 weeks).
Changes in nutrient intake
Time frame: End of treatment (4 weeks), Follow up (8 weeks).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
- Derived from this study: PubMed 40025494Johnstone N, Cohen Kadosh K. Indicators of improved emotion behavior in 6-14-year-old children following a 4-week placebo controlled prebiotic supplement intervention at home with a parent. Nutr J. 2025 Mar 1;24(1):34. doi: 10.1186/s12937-025-01098-5.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Galacto-oligosaccharide and Maltodextrin in people with Emotional Regulation, run by University of Surrey at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. 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: finished, as of the sponsor's last update on 14 Feb 2024. 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 United Kingdom. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in trait anxiety. (time frame: End of treatment (4 weeks), Follow up (8 weeks).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06258135, which also lists 1 linked publication.
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 14 Feb 2024.