Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2025-12-30 @ 10:58 PM
Study NCT ID:
NCT05975034
Status:
UNKNOWN
Last Update Posted:
2023-08-03
First Post:
2023-08-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of the Use of a Probiotic Supplement in People With Long COVID
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000094024', 'term': 'Post-Acute COVID-19 Syndrome'}], 'ancestors': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D000094025', 'term': 'Post-Infectious Disorders'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019936', 'term': 'Probiotics'}], 'ancestors': [{'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Computerised randomisation by a researcher in a separate department, probiotic/placebo packaged in identical bottles (label indicates group A or B). Probiotic/placebo delivered directly from supplier to participants (without involvement of the investigators).'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Double-blinded randomised trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-12-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-02', 'studyFirstSubmitDate': '2023-08-02', 'studyFirstSubmitQcDate': '2023-08-02', 'lastUpdatePostDateStruct': {'date': '2023-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fatigue severity scale (FSS)', 'timeFrame': '12 weeks', 'description': "9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle"}, {'measure': 'FACIT fatigue scale', 'timeFrame': '12 weeks', 'description': 'Measure that assesses self-reported fatigue and its impact upon daily activities and function'}, {'measure': 'EQ-5D-5L', 'timeFrame': '12 weeks', 'description': 'Multi-attribute generic health status measure'}, {'measure': 'Ability to Participate in Social Roles and Activities - PROMIS Short Form 8a', 'timeFrame': '12 weeks', 'description': 'Evaluation of ability to participate in social roles and activities'}, {'measure': 'Ecological Momentary Assessment (EMA) app', 'timeFrame': '12 weeks', 'description': 'Symptom data collected using an app (sleep, fatigue, pain, breathlessness, light-headedness, cognitive difficulties)'}], 'secondaryOutcomes': [{'measure': 'IBS-SSS', 'timeFrame': '12 weeks', 'description': 'Composite score of abdominal pain, number of days with abdominal pain, bloating/distension, satisfaction with bowel habits, and IBS-related quality of life'}, {'measure': 'Gastrointestinal Symptom Rating Scale', 'timeFrame': '12 weeks', 'description': '15 items in five symptom clusters: Reflux, Abdominal pain, Indigestion, Diarrhoea and Constipation'}, {'measure': 'MRC Dyspnoea scale', 'timeFrame': '12 weeks', 'description': 'Assesses the degree of functional disability due to dyspnoea'}, {'measure': 'International. Physical Activity Questionnaire (short form)', 'timeFrame': '12 weeks', 'description': 'Assesses moderate-to-vigorous physical activity and sedentary behaviour'}, {'measure': 'Accelerometery data', 'timeFrame': '12 weeks', 'description': 'Longitudinal measurement of movement'}, {'measure': 'Cambridge Neuropsychological Test Automated Battery (CANTAB)', 'timeFrame': '12 weeks', 'description': 'Computer-based cognitive assessment system'}, {'measure': '16S rRNA sequencing', 'timeFrame': '12 weeks', 'description': 'Analysis of the composition and diversity of the gut microbiome'}, {'measure': 'Analysis of inflammatory markers', 'timeFrame': '12 weeks', 'description': 'Measurement of cytokines (including IL-8, IL-6) by ELISA'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Long COVID']}, 'descriptionModule': {'briefSummary': 'This study is a double-blinded randomised trial to assess the efficacy of a probiotic supplement in alleviating symptoms in people with Long COVID.', 'detailedDescription': '240 participants with Long COVID will be randomly assigned to either a probiotic or placebo group in a 1:1 ratio for twelve weeks. Participants will track symptoms using an app for three weeks before the study, and for the last three weeks of the treatment. Participants will answer online questionnaires about their symptoms at 0, 4, 8, and 12 weeks. A subgroup of 60 participants will attend the laboratory for blood tests, cognitive function tests and gut microbiome analysis at 0 and 12 weeks. This group will also wear activity trackers for two weeks before the study, and for the final two weeks of the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: Long COVID defined as National Institute for Health and Care Excellence (NICE) criteria for Long COVID (Persistent symptoms at least 12 weeks after a confirmed or suspected Covid-19 infection).\n\n\\-\n\nExclusion Criteria: Significant co-morbidities - no pre-existing diagnosis of hypertension, diabetes, cerebrovascular, cardiovascular or peripheral vascular disease, coagulopathy or haematological disorder or current or recent cancer.\n\n\\-'}, 'identificationModule': {'nctId': 'NCT05975034', 'briefTitle': 'Investigation of the Use of a Probiotic Supplement in People With Long COVID', 'organization': {'class': 'OTHER', 'fullName': 'Sheffield Hallam University'}, 'officialTitle': 'Investigation of the Use of a Probiotic Supplement in People With Long COVID', 'orgStudyIdInfo': {'id': 'ER45883322'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Probiotic', 'description': 'Participants assigned to the probiotic group.', 'interventionNames': ['Dietary Supplement: Probiotic']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants assigned to the placebo group.', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Probiotic', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Probiotic taken daily for 12 weeks.', 'armGroupLabels': ['Probiotic']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo taken daily for 12 weeks.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'S1 1WB', 'city': 'Sheffield', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Caroline Dalton, PhD', 'role': 'CONTACT', 'email': 'c.f.dalton@shu.ac.uk', 'phone': '44-114-225-3695'}], 'facility': 'Sheffield Hallam University', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}], 'centralContacts': [{'name': 'Caroline Dalton, PhD', 'role': 'CONTACT', 'email': 'c.f.dalton@shu.ac.uk', 'phone': '44-114-225-3695'}], 'overallOfficials': [{'name': 'Caroline Dalton, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sheffield Hallam University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheffield Hallam University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Symprove UK', 'class': 'UNKNOWN'}, {'name': 'Biomesight', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}