Ignite Creation Date:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2026-02-22 @ 2:46 PM
Study NCT ID:
NCT06480812
Status:
COMPLETED
Last Update Posted:
2025-05-15
First Post:
2024-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of Synbiotics in Modulating Host Physiology Via the Gut Microbiome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D058616', 'term': 'Synbiotics'}], 'ancestors': [{'id': 'D056692', 'term': 'Prebiotics'}, {'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019936', 'term': 'Probiotics'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomised Controlled'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-07-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-12-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-12', 'studyFirstSubmitDate': '2024-06-24', 'studyFirstSubmitQcDate': '2024-06-24', 'lastUpdatePostDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in systemic inflammatory profile', 'timeFrame': '6 weeks', 'description': 'Change in circulating markers of systemic inflammation in serum samples collected pre and post the 6-week intervention period.'}], 'secondaryOutcomes': [{'measure': 'Change in gut microbiome profile', 'timeFrame': '6 weeks', 'description': 'Change in gut microbiome profile, assessed using 16s RNA sequencing analysis of faecal samples provided pre and post the 6-week intervention period'}, {'measure': 'Changes in short chain fatty acids (SCFAs)', 'timeFrame': '6 weeks', 'description': 'Change in serum SCFAs measured by mass spectrometry pre and post the 4-week intervention period'}, {'measure': 'Mental Wellbeing as measured by validated questionnaires', 'timeFrame': '6 weeks', 'description': 'The Hospital Anxiety and Depression Survey (HADS) was used to assess subjective measures of anxiety and depression. The scores for each subscale (HADS-Anxiety (A) and HADS-Depression (D)) range from 0 to 21. The cut-off scores range from:\n\n0-7: Normal (no significant symptoms) 8-10: Borderline or mild symptoms 11-21: Clinically significant anxiety or depression'}, {'measure': 'Changes in skin microbiome profile', 'timeFrame': '6 weeks', 'description': 'Change in skin microbiome profile, assessed using 16s RNA sequencing analysis of faecal samples provided pre and post the 6-week intervention period'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '41094562', 'type': 'DERIVED', 'citation': 'Vijay A, Simpson L, Tooley M, Turley S, Kouraki A, Kelly A, Menni C, Armstrong J, Jones S, Valdes AM. The anti-inflammatory effects of three different dietary supplement interventions. J Transl Med. 2025 Oct 16;23(1):1081. doi: 10.1186/s12967-025-07167-x.'}]}, 'descriptionModule': {'briefSummary': 'The current study is a proof of concept mechanistic study that will utilise a combination of prebiotic and probiotic (synbiotic) supplements. The proposed study will improve our understanding of the molecular mechanisms linking nutrition to health outcomes that are mediated by the gut microbiome.', 'detailedDescription': 'The aim of this study is to generate high quality pilot data examining the role of a combination of pre and probiotic (synbiotic) supplementation in improving metabolic health (particularly systemic inflammation) and quality of life.\n\nSpecific Aim 1: To deliver a wealth of data, including effect sizes, on the physiological effects of synbiotic supplementation on the changes in the microbiome and metabolomic profile of an individual.\n\nSpecific Aim 2: To investigate potential mechanisms whereby the gut microbiome modulates crucial physiological parameters such as inflammatory markers and mental well-being measures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant is willing and able to give informed consent for participation in the study\n* Participant eligibility includes those aged \\>18 years who have a body mass index (BMI) between 18.5 and 39.9 kg/m2\n* Have a smart phone in order to download apps on phone\n\nExclusion Criteria:\n\n* Have any gastrointestinal condition or food intolerance which could impact ability to comply with the intervention (e.g. IBS, malabsorptive conditions such as IBD, coeliac)\n* Have lactose intolerance\n* Have diabetes mellitus or any condition with an inflammatory component such as asthma, psoriasis, arthritis etc.\n* Are currently taking fibre or probiotic supplements\n* Are taking any prescribed medication\n* Are currently following or anticipated to commence a specialised commercially available weight loss diet and/or program\n* Are pregnant or breast feeding\n* Currently have a diagnosed psychiatric illness\n* History or current neurological condition (e.g. epilepsy)\n* Have taken part in a research study in the last 3 months involving invasive procedures or an inconvenience allowance'}, 'identificationModule': {'nctId': 'NCT06480812', 'briefTitle': 'The Role of Synbiotics in Modulating Host Physiology Via the Gut Microbiome', 'organization': {'class': 'OTHER', 'fullName': 'University of Nottingham'}, 'officialTitle': 'The Role of a Synbiotic in Modulating Host Physiology Via the Gut Microbiome- A Pilot Randomised Controlled Dietary Intervention Study', 'orgStudyIdInfo': {'id': 'FMHS 314-0623'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Synbiotic arm', 'description': 'Synbiotic mixure (10g prebiotic fibre + 170ml kefir) will be randomly allocated to eligible participants in order to test specific effects of the synbiotic mixture on gut microbiome composition and metabolic markers.', 'interventionNames': ['Dietary Supplement: Synbiotic']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Individuals in the control arm will not be provided with the test supplement and asked to carry on with their usual diet and lifestyle.', 'interventionNames': ['Dietary Supplement: Synbiotic']}], 'interventions': [{'name': 'Synbiotic', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The proposed protocol will provide a simple but robust intervention study using a synbiotic (pre and probiotic combination) in order to improve our understanding of the mechanisms linking nutrition to health outcomes that are mediated by the gut microbiome.\n\nThis pilot study will comprise a controlled randomised intervention in which participants will be grouped into the active synbiotic arm or the control arm. The ratios will be 10g of the prebiotic supplement and 170ml of kefir. Randomisation will control for equal distribution of age and biological sex; characteristics that may confound between group comparisons and will be assessed by analysis of baseline data.', 'armGroupLabels': ['Control', 'Synbiotic arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NG7 2UH', 'city': 'Nottingham', 'country': 'United Kingdom', 'facility': 'University of Nottingham', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}], 'overallOfficials': [{'name': 'Amrita Vijay, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Nottingham'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'All data arising from the current study will be fully anonymised and used for publication purposes'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Elizabeth Simpson', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Senior Research Fellow', 'investigatorFullName': 'Elizabeth Simpson', 'investigatorAffiliation': 'University of Nottingham'}}}}