Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 11:55 PM
Study NCT ID:
NCT03554694
Status:
UNKNOWN
Last Update Posted:
2018-06-13
First Post:
2018-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gut-brain Axis, Brain Function, and Behaviour.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D056692', 'term': 'Prebiotics'}, {'id': 'C008315', 'term': 'maltodextrin'}], 'ancestors': [{'id': 'D004043', 'term': 'Dietary Fiber'}, {'id': 'D004040', 'term': 'Dietary Carbohydrates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D011135', 'term': 'Polysaccharides, Bacterial'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Both intervention and placebo products are similar in colour, texture, and taste. A third party, independent of the daya-to-day research coordinator, will randomise treatments.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-05-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-06-11', 'studyFirstSubmitDate': '2018-05-09', 'studyFirstSubmitQcDate': '2018-06-11', 'lastUpdatePostDateStruct': {'date': '2018-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cortisol awakening response (CAR)', 'timeFrame': '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).', 'description': '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)'}, {'measure': 'Brain imaging (BOLD fMRI activity) in amygdala and cortical regions', 'timeFrame': '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).', 'description': '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)'}], 'secondaryOutcomes': [{'measure': 'Changes in gut microbiome', 'timeFrame': '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).', 'description': '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'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prebiotics', 'Anxiety', 'Humans', 'Magnetic Resonance Imaging', 'Decision Making', 'Emotion', 'Cortisol']}, 'referencesModule': {'references': [{'pmid': '25449699', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '16956980', 'type': 'BACKGROUND', 'citation': 'Bishop 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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Trait anxiety levels \\> 40 on STAI trait inventory\n* Participant is willing and able to give informed consent for participation in the study\n* Not currently taking any psychoactive medications\n\nExclusion Criteria:\n\n* Pregnant participants\n* No contraindications to prebiotic administration\n* Antibiotic, probiotics and/or prebiotic treatment in at least the two previous months.\n* Participants who are taking any other food supplements that, in the opinion of the Investigators, may affect the results.\n* Participants who are taking any medications that, in the opinion of the Investigators, may affect the results.\n* Any significant change in diet which, at the discretion of the Investigators, may affect the results.\n* Participants who have recently participated in another research trial which, at the discretion of the Investigators, may affect the results.\n* A history of dementia, traumatic brain injury or stroke.\n* Anyone who is unable to perform the behavioural tasks.\n* Current use of any psychoactive medication.\n* Current use of psychological treatment.\n* Anyone who does not have adequate understanding of English, sufficient to give informed consent.\n* 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.\n* Anyone with any metal implants or implantable device would be excluded from any brain imaging studies as indicated by the MRI safety screening form.'}, 'identificationModule': {'nctId': 'NCT03554694', 'briefTitle': 'Gut-brain Axis, Brain Function, and Behaviour.', 'organization': {'class': 'OTHER', 'fullName': 'University of Oxford'}, 'officialTitle': 'Does Stimulating Friendly Gut Bacteria Improve Brain Function and Behaviour?', 'orgStudyIdInfo': {'id': 'R52324_RE001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Start with prebiotics', 'description': '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.', 'interventionNames': ['Dietary Supplement: Prebiotics']}, {'type': 'EXPERIMENTAL', 'label': 'Start with placebo', 'description': '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.', 'interventionNames': ['Dietary Supplement: Maltodextrin (placebo)']}], 'interventions': [{'name': 'Prebiotics', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Galactooligosaccharides (GOS) (prebiotics) will be consumed by the participants for 4-6 weeks', 'armGroupLabels': ['Start with prebiotics']}, {'name': 'Maltodextrin (placebo)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Maltodextrin (placebo) will be consumed by the participants for 4-6 weeks', 'armGroupLabels': ['Start with placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'OX3 9DU', 'city': 'Oxford', 'state': 'Oxfordshire', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'University o Oxford', 'role': 'CONTACT', 'email': 'gershon.spitz@ndcn.ox.ac.uk', 'phone': '07438239953'}], 'facility': 'University of Oxford', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}], 'centralContacts': [{'name': 'Gershon Spitz, PhD', 'role': 'CONTACT', 'email': 'gershon.spitz@ndcn.ox.ac.uk', 'phone': '+44 (0)1865611456'}], 'overallOfficials': [{'name': "Jacinta O'Shea, PhD", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Oxford'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "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."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oxford', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Health and Medical Research Council, Australia', 'class': 'OTHER'}, {'name': 'Oxford Health Biomedical Research Centre (OH BRC) support scheme', 'class': 'UNKNOWN'}, {'name': 'Wellcome Centre for Integrative Neuroimaging', 'class': 'UNKNOWN'}, {'name': 'Monash University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}