PrebioticsNCT03554694
Gut-brain Axis, Brain Function, and Behaviour.
A study testing Prebiotics in people with Prebiotics and Anxiety, run by University of Oxford at 1 site in United Kingdom.
Trial summary
The aim is to test if dietary supplementation with prebiotics reduces measures of anxiety in healthy human participants with high self-reported levels of anxiety. Study will test for an effect on behavioural, neuroendocrine and brain imaging markers of anxiety. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Prebiotics, Anxiety, Humans
- What is being tested?
- Prebiotics
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 May 2018to 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Trait anxiety levels > 40 on STAI trait inventory
- Participant is willing and able to give informed consent for participation in the study
- Not currently taking any psychoactive medications
Who cannot join
- Pregnant participants
- No contraindications to prebiotic administration
- Antibiotic, probiotics and/or prebiotic treatment in at least the two previous months.
- Participants who are taking any other food supplements that, in the opinion of the Investigators, may affect the results.
- Participants who are taking any medications that, in the opinion of the Investigators, may affect the results.
- Any significant change in diet which, at the discretion of the Investigators, may affect the results.
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- Participants who have recently participated in another research trial which, at the discretion of the Investigators, may affect the results.
- A history of dementia, traumatic brain injury or stroke.
- Anyone who is unable to perform the behavioural tasks.
- Current use of any psychoactive medication.
- Current use of psychological treatment.
- Anyone who does not have adequate understanding of English, sufficient to give informed consent.
- Any person who has a history of drug abuse or a previous history of a neurological, or has a history of neurosurgical procedure is excluded as they may be at increased risk of epilepsy and data collected may be influenced by their condition.
- Anyone with any metal implants or implantable device would be excluded from any brain imaging studies as indicated by the MRI safety screening form.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Oxford
Oxford, Oxfordshire, OX3 9DU
University o Oxford, 07438239953, gershon.spitz@ndcn.ox.ac.uk
About this study
Official title: Does Stimulating Friendly Gut Bacteria Improve Brain Function and Behaviour?
The aim is to test if dietary supplementation with prebiotics reduces measures of anxiety in healthy human participants with high self-reported levels of anxiety. Study will test for an effect on behavioural, neuroendocrine and brain imaging markers of anxiety.
- Conditions
- Prebiotics, Anxiety, Humans, Magnetic Resonance Imaging, Decision Making, Emotion
- Being tested
- Prebiotics, Maltodextrin (placebo)
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrebioticsDietary supplement
Galactooligosaccharides (GOS) (prebiotics) will be consumed by the participants for 4-6 weeks
Maltodextrin (placebo)Dietary supplement
Maltodextrin (placebo) will be consumed by the participants for 4-6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Start with prebiotics | Experimental | Half of the participants start with prebiotics, followed by a testing period. After a wash-out period they will continue with placebo followed by a testing period. Receives: Dietary Supplement: Prebiotics |
| Start with placebo | Experimental | Half of the participants start with placebo, followed by a testing period. After a wash-out period they will continue with prebiotics followed by a testing period. Receives: Dietary Supplement: Maltodextrin (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cortisol awakening response (CAR)
CAR, a marker of stress responsivity, should be decreased after taking prebiotics compared to placebo (as previously found in non-anxious participants in Schmidt et al., 2015, Psychopharmacology)
Measured: Cortisol awakening responses will be measured at the end of the first intervention phase (4-6 weeks after study entry) and at the end of the second intervention phase (11-15 weeks post study entry).
Brain imaging (BOLD fMRI activity) in amygdala and cortical regions
Brain imaging (BOLD fMRI activity) in amygdala and cortical regions Will provide neural measures of threat reactivity. We predict decreased amygdala and/or increased parietal-prefrontal brain activity after prebiotics compared to placebo, indicating an anxiolytic-like profile (fearful -neutral face trials in the low load condition) (as in Bishop et al, 2007 and Ironside et al, 2017)
Measured: Brain imaging will be measured at the end of the first intervention phase (4-6 weeks after study entry) and at the end of the second intervention phase (11-15 weeks post study entry).
Secondary outcomes (1)
Changes in gut microbiome
Availability of specific bacteria in microbiome will change as function of prebiotics and not during placebo. The change will be measured at the start of each intervention compared to the end of each intervention
Measured: Changes in the microbiome will be measure using a single stool/faecal sample at four time points: baseline (0 weeks), following first intervention (4-6 weeks), following washout (7-9 weeks), and following the second intervention (11-15 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2018
- Study start6 May 2018
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PrebioticsStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- 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
- Crossover
- Model description
- Crossover Assignment Randomised Double-blind Cross-over design with 4-6 weeks of prebiotics intervention and 4-6 weeks of placebo intervention. The first intervention phase will be followed by a 3 week wash-out period prior to the second intervention phase.d.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia, National Institute for Health Research, United Kingdom, Wellcome Centre for Integrative Neuroimaging, Monash University
- Responsible party
- Sponsor
- Investigators
- Jacinta O'Shea, PhD, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03554694
- Sponsor's protocol ID
- R52324_RE001
- Status last verified
- May 2018
- First submitted
- 9 May 2018
- Last updated
- 13 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study staff will ensure that the participants' data are safeguarded. The study will comply with the Data Protection Act, which requires personal data to be anonymised as soon as it is practical to do so. Students and collaborators may be given access to fully anonymized data under the supervision of the named investigators. Some peer-reviewed journals require submission of anonymised data that may also be uploaded to other data sharing initiatives. Access may be given to responsible members of the University of Oxford for the purposes of monitoring or audit. The participants' consent will be sought if this is to occur.
Publications
Schmidt K, Cowen PJ, Harmer CJ, Tzortzis G, Errington S, Burnet PW. Prebiotic intake reduces the waking cortisol response and alters emotional bias in healthy volunteers. Psychopharmacology (Berl). 2015 May;232(10):1793-801. doi: 10.1007/s00213-014-3810-0. Epub 2014 Dec 3.
PubMed 25449699Bishop SJ, Jenkins R, Lawrence AD. Neural processing of fearful faces: effects of anxiety are gated by perceptual capacity limitations. Cereb Cortex. 2007 Jul;17(7):1595-603. doi: 10.1093/cercor/bhl070. Epub 2006 Sep 6.
PubMed 16956980
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Stimulating Friendly Gut Bacteria Improve Brain Function and Behaviour?
- ClinicalTrials.gov ID
- NCT03554694
- Acronym / sponsor ID
- R52324_RE001
- Conditions
- Prebiotics, Anxiety, Humans, Magnetic Resonance Imaging, Decision Making, Emotion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia, National Institute for Health Research, United Kingdom, Wellcome Centre for Integrative Neuroimaging, Monash University
- Study start
- 6 May 2018 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 13 Jun 2018 (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.
The aim is to test if dietary supplementation with prebiotics reduces measures of anxiety in healthy human participants with high self-reported levels of anxiety. Study will test for an effect on behavioural, neuroendocrine and brain imaging markers of anxiety.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Crossover Assignment Randomised Double-blind Cross-over design with 4-6 weeks of prebiotics intervention and 4-6 weeks of placebo intervention. The first intervention phase will be followed by a 3 week wash-out period prior to the second intervention phase.d.
| Arm | Type | Receives |
|---|---|---|
| Start with prebiotics | Experimental | Dietary Supplement: PrebioticsHalf of the participants start with prebiotics, followed by a testing period. After a wash-out period they will continue with placebo followed by a testing period. |
| Start with placebo | Experimental | Dietary Supplement: Maltodextrin (placebo)Half of the participants start with placebo, followed by a testing period. After a wash-out period they will continue with prebiotics followed by a testing period. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Trait anxiety levels > 40 on STAI trait inventory
- Participant is willing and able to give informed consent for participation in the study
- Not currently taking any psychoactive medications
Key exclusion criteria (14 listed)
- Pregnant participants
- No contraindications to prebiotic administration
- Antibiotic, probiotics and/or prebiotic treatment in at least the two previous months.
- Participants who are taking any other food supplements that, in the opinion of the Investigators, may affect the results.
- Participants who are taking any medications that, in the opinion of the Investigators, may affect the results.
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 |
|---|---|---|
| PrebioticsGalactooligosaccharides (GOS) (prebiotics) will be consumed by the participants for 4-6 weeks | Dietary supplement | Start with prebiotics |
| Maltodextrin (placebo)Maltodextrin (placebo) will be consumed by the participants for 4-6 weeks | Dietary supplement | Start with placebo |
Primary outcome
Cortisol awakening response (CAR)
Time frame: Cortisol awakening responses will be measured at the end of the first intervention phase (4-6 weeks after study entry) and at the end of the second intervention phase (11-15 weeks post study entry).
CAR, a marker of stress responsivity, should be decreased after taking prebiotics compared to placebo (as previously found in non-anxious participants in Schmidt et al., 2015, Psychopharmacology)
Brain imaging (BOLD fMRI activity) in amygdala and cortical regions
Time frame: Brain imaging will be measured at the end of the first intervention phase (4-6 weeks after study entry) and at the end of the second intervention phase (11-15 weeks post study entry).
Brain imaging (BOLD fMRI activity) in amygdala and cortical regions Will provide neural measures of threat reactivity. We predict decreased amygdala and/or increased parietal-prefrontal brain activity after prebiotics compared to placebo, indicating an anxiolytic-like profile (fearful -neutral face trials in the low load condition) (as in Bishop et al, 2007 and Ironside et al, 2017)
1 secondary outcome
Changes in gut microbiome
Time frame: Changes in the microbiome will be measure using a single stool/faecal sample at four time points: baseline (0 weeks), following first intervention (4-6 weeks), following washout (7-9 weeks), and following the second intervention (11-15 weeks).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2018.
- Background: PubMed 25449699Schmidt K, Cowen PJ, Harmer CJ, Tzortzis G, Errington S, Burnet PW. Prebiotic intake reduces the waking cortisol response and alters emotional bias in healthy volunteers. Psychopharmacology (Berl). 2015 May;232(10):1793-801. doi: 10.1007/s00213-014-3810-0. Epub 2014 Dec 3.
- Background: PubMed 16956980Bishop SJ, Jenkins R, Lawrence AD. Neural processing of fearful faces: effects of anxiety are gated by perceptual capacity limitations. Cereb Cortex. 2007 Jul;17(7):1595-603. doi: 10.1093/cercor/bhl070. Epub 2006 Sep 6.
- Individual participant dataSharing planned: No. The study staff will ensure that the participants' data are safeguarded. The study will comply with the Data Protection Act, which requires personal data to be anonymised as soon as it is practical to do so. Students and collaborators may be given access to fully anonymized data under the supervision of the named investigators. Some peer-reviewed journals require submission of anonymised data that may also be uploaded to other data sharing initiatives. Access may be given to responsible members of the University of Oxford for the purposes of monitoring or audit. The participants' consent will be sought if this is to occur.
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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.
Jacinta O'Shea, PhD principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prebiotics in people with Prebiotics and Anxiety, run by University of Oxford 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 3 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 13 Jun 2018. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gershon Spitz, PhD (+44 (0)1865611456, gershon.spitz@ndcn.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cortisol awakening response (CAR) (time frame: Cortisol awakening responses will be measured at the end of the first intervention phase (4-6 weeks after study entry) and at the end of the second intervention phase (11-15 weeks post study entry).). 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 NCT03554694, which also lists 2 linked publications.
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 13 Jun 2018.