Emotion RegulationNCT04616937
Prebiotics and Mental Health: Behavioural
A study testing GOS in people with Emotion Regulation and Anxiety, run by University of Surrey at 1 site in United Kingdom.
Trial summary
A behavioural study of the microbiota-gut-brain axis in brain development and mental health Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Emotion Regulation, Anxiety
- What is being tested?
- GOS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Feb 2018to 1 Jan 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 18 to 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Females
- Aged between 18-25
Who cannot join
- Clinical levels of anxiety and/ or co-morbid diagnoses (e.g. depression)
- Current or previous neurological disorders
- Current or previous psychiatric disorders
- Current or previous gastrointestinal disorders
- Current or previous endocrine disorders
- Antibiotic use 3 months prior to the study
Show all 9Show fewer
- Regular use of pre- and probiotics, including 3 months prior to the study
- Vegan diets
- BMI >30
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of the Microbiota-gut-brain Axis in Brain Development and Mental Health: Behavioural
A behavioural study of the microbiota-gut-brain axis in brain development and mental health
Read the detailed description
Research suggests that modifying microbial ecology therapeutically via the intake of so-called 'psychobiotics' could help reduce stress responses and symptoms of anxiety and depression (Burnet \& Cowen, 2013; Dinan, Stanton, \& Cryan, 2013; Tang, Reddy, \& Saier, 2014). The term psychobiotics refers to both, beneficial gut bacteria (probiotics), as well as prebiotics, which enhance the growth of beneficial gut bacteria (Sarkar et al., 2016). In a recent study, Schmidt and colleagues explored the effects of prebiotics on the secretion of the stress hormone cortisol and emotional processing in healthy volunteers (Schmidt et al., 2015). They found that cortical awakening response was significantly lower after BimunoÒ-galacto-oligosaccharides (Bimuno) intake over 4 weeks compared with placebo. Moreover, participants exhibited decreased attentional vigilance to negative information in a dot-probe task. Given that anxious people show increased biases towards negative information (Bar-Haim, Lamy, Pergamin, Bakermans-Kranenburg, \& van, 2007), this suggests that prebiotic intake may be useful in modifying anxiety-related cognitive mechanisms.
These findings will be extended to a sample of late adolescents in order to investigate how prebiotic intake for 4 weeks affects cognitive functioning, psychological well-being and gut microbiota a sample of 60 undergraduate students (aged 18-25 years).
At time 1 (pre-assessment), participants in both groups will undergo comprehensive behavioural and psychological testing to establish baseline measures of cognitive functioning and psychological well-being (such as anxiety levels) and asked to collect a stool sample at home for 16s rRNA sequencing of the microbiome. Group 1 will then receive a daily dosage of a galactooligosaccharide (GOS) prebiotic over 4 weeks, whereas group 2 will receive a placebo over the same period. At time 2 (post-assessment), both groups will again undergo cognitive and psychological testing and stool sampling.
Hypothesis: It is predicted that the treatment group (GOS) will show improvements in behavioural indices of emotion regulation (e.g. dot probe task) and in self reported psychological measures related to emotion regulation (e.g. anxiety) in comparison to the placebo group. Changes/differences in gut microbiome samples will be explored.
- Conditions
- Emotion Regulation, Anxiety
- Being tested
- GOS, Placebo
- Medical subject headings
- Emotional Regulation, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GOSDietary supplement
Prebiotic
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Galacto-oligosaccharides (GOS) Group | Active comparator | Daily dose of GOS over 4 weeks Receives: Dietary Supplement: GOS |
| Placebo group | Placebo comparator | Daily dose of maltodextrin over 4 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioural indices of emotion regulation
Changes in performance on dot-probe task measured as attentional bias to emotional stimuli in milliseconds in the prebiotic group compared to placebo. Increased attentional bias to positive stimuli and/or decreased attentional bias to negative stimuli is the desired outcome.
Measured: 4 weeks
Changes in self reported indices of anxiety.
Changes in self reported anxiety as measured by the Trait Anxiety subscale of the State-Trait Anxiety Inventory (Spielberger, 1978) in the prebiotic group compared to placebo group. For this inventory, a lower overall score is the desired outcome.
Measured: 4 weeks
Changes in self reported indices of anxiety 2.
Changes in self reported anxiety as measured by the State Anxiety subscale of the State-Trait Anxiety Inventory (Spielberger, 1978) in the prebiotic group compared to placebo group. For this inventory, a lower overall score is the desired outcome.
Measured: 4 weeks
Changes in self reported indices of anxiety 3.
Changes in self reported social anxiety measured by Social Anxiety Scales (La G reca 1999) in the prebiotic group compared to placebo group. For this scale, a lower overall score is the desired outcome.
Measured: 4 weeks
Changes in self reported emotion regulation (Thought control ability).
Changes in the prebiotic group compared to placebo for Thought control ability (Luciano et al 2005). For this questionnaire, a higher overall score is the desired outcome.
Measured: 4 weeks
Changes in self reported emotion regulation (Emotion regulation strategies).
Changes in the prebiotic group compared to placebo for emotion regulation strategies (Gross \& John, 2003). For this questionnaire, a higher overall score is the desired outcome.
Measured: 4 weeks
Changes in self reported mood
Changes in the prebiotic group compared to placebo for mood and feelings as measured by the mood and feelings questionnaire (Angold etal., 1995). A lower overall score is the desired outcome.
Measured: 4 weeks
Changes in self reported depression.
Changes in the prebiotic group compared to placebo for depression as measured by the Depression inventory (Beck \& Steer, 1984). A lower score is the desired outcome.
Measured: 4 weeks
Secondary outcomes (1)
Gut microbiota changes
Changes in gut microbiome composition in diversity, or in abundance of genera (%) (e.g. Bifidobacterium) from pre to post assessment in prebiotic group compared to placebo OR between prebiotic and placebo groups at post assessment.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study start1 Feb 2018
- Primary completion1 Jan 2019
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotion 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Surrey
- Sponsor type
- University, hospital or other
- Collaborators
- FrieslandCampina
- Responsible party
- Principal investigator, Katherin Cohen-Kadosh, University of Surrey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04616937
- Sponsor's protocol ID
- PrebioticStudy
- Status last verified
- Nov 2020
- First submitted
- 28 Oct 2020
- Last updated
- 5 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of the Microbiota-gut-brain Axis in Brain Development and Mental Health: Behavioural
- ClinicalTrials.gov ID
- NCT04616937
- Acronym / sponsor ID
- PrebioticStudy
- Conditions
- Emotion Regulation, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of SurreyUniversity, hospital or other
- Collaborators
- FrieslandCampina
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 5 Nov 2020 (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.
A behavioural study of the microbiota-gut-brain axis in brain development and mental health
Detailed description
Research suggests that modifying microbial ecology therapeutically via the intake of so-called 'psychobiotics' could help reduce stress responses and symptoms of anxiety and depression (Burnet \& Cowen, 2013; Dinan, Stanton, \& Cryan, 2013; Tang, Reddy, \& Saier, 2014). The term psychobiotics refers to both, beneficial gut bacteria (probiotics), as well as prebiotics, which enhance the growth of beneficial gut bacteria (Sarkar et al., 2016). In a recent study, Schmidt and colleagues explored the effects of prebiotics on the secretion of the stress hormone cortisol and emotional processing in healthy volunteers (Schmidt et al., 2015). They found that cortical awakening response was significantly lower after BimunoÒ-galacto-oligosaccharides (Bimuno) intake over 4 weeks compared with placebo. Moreover, participants exhibited decreased attentional vigilance to negative information in a dot-probe task. Given that anxious people show increased biases towards negative information (Bar-Haim, Lamy, Pergamin, Bakermans-Kranenburg, \& van, 2007), this suggests that prebiotic intake may be useful in modifying anxiety-related cognitive mechanisms.
These findings will be extended to a sample of late adolescents in order to investigate how prebiotic intake for 4 weeks affects cognitive functioning, psychological well-being and gut microbiota a sample of 60 undergraduate students (aged 18-25 years).
At time 1 (pre-assessment), participants in both groups will undergo comprehensive behavioural and psychological testing to establish baseline measures of cognitive functioning and psychological well-being (such as anxiety levels) and asked to collect a stool sample at home for 16s rRNA sequencing of the microbiome. Group 1 will then receive a daily dosage of a galactooligosaccharide (GOS) prebiotic over 4 weeks, whereas group 2 will receive a placebo over the same period. At time 2 (post-assessment), both groups will again undergo cognitive and psychological testing and stool sampling.
Hypothesis: It is predicted that the treatment group (GOS) will show improvements in behavioural indices of emotion regulation (e.g. dot probe task) and in self reported psychological measures related to emotion regulation (e.g. anxiety) in comparison to the placebo group. Changes/differences in gut microbiome samples will be explored.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Galacto-oligosaccharides (GOS) Group | Active comparator | Dietary Supplement: GOSDaily dose of GOS over 4 weeks |
| Placebo group | Placebo comparator | Dietary Supplement: PlaceboDaily dose of maltodextrin over 4 weeks |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Females
- Aged between 18-25
Key exclusion criteria (9 listed)
- Clinical levels of anxiety and/ or co-morbid diagnoses (e.g. depression)
- Current or previous neurological disorders
- Current or previous psychiatric disorders
- Current or previous gastrointestinal disorders
- Current or previous endocrine disorders
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 |
|---|---|---|
| GOSPrebiotic | Dietary supplement | Galacto-oligosaccharides (GOS) Group |
| PlaceboPlacebo | Dietary supplement | Placebo group |
Primary outcome
Behavioural indices of emotion regulation
Time frame: 4 weeks
Changes in performance on dot-probe task measured as attentional bias to emotional stimuli in milliseconds in the prebiotic group compared to placebo. Increased attentional bias to positive stimuli and/or decreased attentional bias to negative stimuli is the desired outcome.
Changes in self reported indices of anxiety.
Time frame: 4 weeks
Changes in self reported anxiety as measured by the Trait Anxiety subscale of the State-Trait Anxiety Inventory (Spielberger, 1978) in the prebiotic group compared to placebo group. For this inventory, a lower overall score is the desired outcome.
Changes in self reported indices of anxiety 2.
Time frame: 4 weeks
Changes in self reported anxiety as measured by the State Anxiety subscale of the State-Trait Anxiety Inventory (Spielberger, 1978) in the prebiotic group compared to placebo group. For this inventory, a lower overall score is the desired outcome.
Changes in self reported indices of anxiety 3.
Time frame: 4 weeks
Changes in self reported social anxiety measured by Social Anxiety Scales (La G reca 1999) in the prebiotic group compared to placebo group. For this scale, a lower overall score is the desired outcome.
Changes in self reported emotion regulation (Thought control ability).
Time frame: 4 weeks
Changes in the prebiotic group compared to placebo for Thought control ability (Luciano et al 2005). For this questionnaire, a higher overall score is the desired outcome.
Changes in self reported emotion regulation (Emotion regulation strategies).
Time frame: 4 weeks
Changes in the prebiotic group compared to placebo for emotion regulation strategies (Gross \& John, 2003). For this questionnaire, a higher overall score is the desired outcome.
Changes in self reported mood
Time frame: 4 weeks
Changes in the prebiotic group compared to placebo for mood and feelings as measured by the mood and feelings questionnaire (Angold etal., 1995). A lower overall score is the desired outcome.
Changes in self reported depression.
Time frame: 4 weeks
Changes in the prebiotic group compared to placebo for depression as measured by the Depression inventory (Beck \& Steer, 1984). A lower score is the desired outcome.
1 secondary outcome
Gut microbiota changes
Time frame: 4 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 5 Nov 2020.
- 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 GOS in people with Emotion Regulation and Anxiety, 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 9 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 5 Nov 2020. 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?
Behavioural indices of emotion regulation (time frame: 4 weeks). The study lists 8 primary outcomes in all. 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 Nov 2020.