Ignite Creation Date:
2025-12-24 @ 3:40 PM
Ignite Modification Date:
2026-01-01 @ 4:31 PM
Study NCT ID:
NCT01087892
Status:
COMPLETED
Last Update Posted:
2020-03-30
First Post:
2010-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Probiotics in Preventing Antibiotic Associated Diarrhoea Including Clostridium Difficile Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-02-21', 'releaseDate': '2022-05-18'}], 'estimatedResultsFirstSubmitDate': '2022-05-18'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003967', 'term': 'Diarrhea'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1126}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-27', 'studyFirstSubmitDate': '2010-03-15', 'studyFirstSubmitQcDate': '2010-03-15', 'lastUpdatePostDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-03-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence of diarrhoea', 'timeFrame': 'regular intervals for 28days from entry to trial', 'description': 'The incidence of antibiotic associated diarrhoea in the active and placebo group by the end of the follow up period'}], 'secondaryOutcomes': [{'measure': 'incidence and duration of Clostridium difficile toxin', 'timeFrame': 'regular intervals for 28 days from entry to trial', 'description': 'The incidence and duration of Clostridium difficile toxin detected by ELISA positive testing from a stool sample taken at the onset of diarrhoea in the active and placebo groups'}, {'measure': 'The rate of recurrence of antibiotic associated diarrhoea in the active and placebo groups to the end of the follow up period', 'timeFrame': 'regular intervals for 28 days from entry to trial', 'description': 'The rate of recurrence of antibiotic associated diarrhoea in the active and placebo groups to the end of the follow up period'}, {'measure': 'rate of recurrence of Clostridium difficile toxin positive diarrhoea', 'timeFrame': 'regular intervals for 28 days from entry to trial', 'description': 'The rate of recurrence of Clostridium difficile toxin positive diarrhoea in the active and placebo groups from hospital discharge until the end of the follow-up period'}, {'measure': 'The quality of life in the active and placebo groups at enrollment into the study', 'timeFrame': 'regular intervals for 28 days from entry to trial'}, {'measure': 'The length of hospital stay from enrollment into the study until the end of the follow up period in the active and placebo groups The cost-effectiveness as evidenced by health economic calculations', 'timeFrame': 'regular intervals for 28 days from entry to trial'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Diarrhoea', 'Clostridium Difficile']}, 'descriptionModule': {'briefSummary': "Antibiotics are currently required to treat patients in hospital when they have an infection, but these antibiotics can cause side effects such as diarrhoea and in some patients a serious form of gut infection with an organism called Clostridium difficile. This organism can produce toxins in the gut causing a severe form of diarrhoea associated with a lot of ill health, and in some circumstances can be fatal. Some studies have shown that yogurts' or Probiotics' (special drinks with a defined concentration of useful bacteria) taken by patients can have a beneficial effect in reducing the diarrhoea associated with antibiotics use. The aim of the present study is to find out whether the use of one of these Probiotics in hospitalised patients taking antibiotics will result in less diarrhoea, less Clostridium difficile infection, as well as cost saving. The study will also analyze the effects of probiotics on quality of life and length of hospital stay.", 'detailedDescription': 'As part of this study, we will look at both microbiological and immunological markers, in addition to analyzing the overall cost implications by analysis of health economics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male/female patients, above 55 years of age Patient has given written informed consent/Assent to take part in the study Patients are receiving antibiotics as inpatients Patients prescribed therapy with single or multiple antibiotics (oral or IV) will be included Antibiotic therapy must be indicated for a minimum of 72 hours Patients must be able to take medication orally Inclusion in the study is approved by the admitting consultant and validated by a member of the trial team within 48 hours\n\nExclusion Criteria:\n\n* Age less than 55 years Pregnancy Patients on PEG feed. Diarrhoea on admission or within the preceding week Severe life-threatening illness\n\nSubjects with allergy or hypersensitivity to any component of the study product (e.g.: allergy or hypersensitivity to milk proteins) Subjects who had any surgery or intervention in the last 4 weeks Subjects enrolled in another clinical study in the last 4 weeks Subjects who are thought not to comply with the clinical study Subjects presenting with a severe evolving or active pathology or infection of the gastrointestinal tract such as inflammatory bowel disease, Crohn's disease or ulcerative colitis, diverticular disease or liver cirrhosis.\n\nAny condition affecting the pancreas including acute and chronic pancreatitis Patients who had a surgical operation in their bowels in the preceding 3 months A medical condition such that the life expectancy of the patient is predicted at less than 3 months by the admitting consultant and validated by a member of the trial team Immune-suppressed patients (e.g. HIV) Steroid use of Prednisolone greater than 10mg a day (or equivalent of Dexamethasone) for over 2 weeks prior to entering the trial Patients on Cytotoxic drugs Post-transplant patients Any clinical condition affecting the pancreas including acute and chronic pancreatitis Patients with prosthetic heart valves or a history of endocarditis. Patients who have taken probiotic drinks containing live organisms or over the counter probiotic preparations in the past seven days (see Appendix 10) Foreign travel in the last 7 days"}, 'identificationModule': {'nctId': 'NCT01087892', 'acronym': 'NU278', 'briefTitle': 'Probiotics in Preventing Antibiotic Associated Diarrhoea Including Clostridium Difficile Infection', 'organization': {'class': 'OTHER', 'fullName': 'University of Sussex'}, 'officialTitle': 'Probiotics in Preventing Antibiotic Associated Diarrhoea Including Clostridium Difficile Infection', 'orgStudyIdInfo': {'id': 'UKCRN7582'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dietary supplement Probiotic drink', 'description': 'Double blind\n\nProbiotic containing the live strain 100g/day orally, twice daily for the duration of the course of antibiotics plus seven days', 'interventionNames': ['Dietary Supplement: Probiotic drink containing the live strain']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Dietary supplement probiotic placebo drink', 'description': "Double blind\n\n'placebo' is actually a control product\n\nPlacebo drink contains no strain 100gs orally, twice daily for the duration of the course of antibiotics plus seven days", 'interventionNames': ['Dietary Supplement: placebo probiotic']}], 'interventions': [{'name': 'Probiotic drink containing the live strain', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Probiotic drink contains no strain', 'armGroupLabels': ['Dietary supplement Probiotic drink']}, {'name': 'placebo probiotic', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo product is a sweetened flavoured, non fermented, acidified dairy drink', 'armGroupLabels': ['Dietary supplement probiotic placebo drink']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'KT 0PZ', 'city': 'Ashford', 'country': 'United Kingdom', 'facility': 'Ashford and St Peters Hospital', 'geoPoint': {'lat': 51.14648, 'lon': 0.87376}}, {'zip': 'FY3 8NR', 'city': 'Blackpool', 'country': 'United Kingdom', 'facility': 'Blackpool Vicotria Hospital', 'geoPoint': {'lat': 53.81667, 'lon': -3.05}}, {'zip': 'BN2 5BE', 'city': 'Brighton', 'country': 'United Kingdom', 'facility': 'Royal Sussex County Hospital', 'geoPoint': {'lat': 50.82838, 'lon': -0.13947}}, {'zip': 'CB2 2QQ', 'city': 'Cambridge', 'country': 'United Kingdom', 'facility': 'Cambridge University Hospital Trust', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'CM1 7HT', 'city': 'Chelmsford', 'country': 'United Kingdom', 'facility': 'Broomfield Hospital', 'geoPoint': {'lat': 51.73575, 'lon': 0.46958}}, {'zip': 'PO19 6SE', 'city': 'Chichester', 'country': 'United Kingdom', 'facility': 'St.Richards Hospital', 'geoPoint': {'lat': 50.83673, 'lon': -0.78003}}, {'zip': 'CO4 5JL', 'city': 'Colchester', 'country': 'United Kingdom', 'facility': 'Colchester Hospitals University', 'geoPoint': {'lat': 51.88921, 'lon': 0.90421}}, {'zip': 'UB1 3HW', 'city': 'Ealing', 'country': 'United Kingdom', 'facility': 'Ealing Hospital', 'geoPoint': {'lat': 51.51216, 'lon': -0.30204}}, {'zip': 'BN21 2YS', 'city': 'Eastbourne', 'country': 'United Kingdom', 'facility': 'Eastbourne District General Hospital', 'geoPoint': {'lat': 50.76871, 'lon': 0.28453}}, {'zip': 'SW17 7HS', 'city': 'Frimley', 'country': 'United Kingdom', 'facility': 'Frimley Park Hospital', 'geoPoint': {'lat': 51.31667, 'lon': -0.74544}}, {'zip': 'RH16 4EX', 'city': 'Haywards Heath', 'country': 'United Kingdom', 'facility': 'Princess Royal Hospital', 'geoPoint': {'lat': 50.99769, 'lon': -0.10313}}, {'zip': 'UB8 3NN', 'city': 'Hillingdon', 'country': 'United Kingdom', 'facility': 'Hillingdon Hospital', 'geoPoint': {'lat': 51.53291, 'lon': -0.45293}}, {'zip': 'PR2 9HT', 'city': 'Lancaster', 'country': 'United Kingdom', 'facility': 'Lancashire Teaching Hospital', 'geoPoint': {'lat': 54.04649, 'lon': -2.79988}}, {'zip': 'LE2 7LX', 'city': 'Leicester', 'country': 'United Kingdom', 'facility': 'University Hosppitals of Leicester', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}, {'zip': 'SE13 6LH', 'city': 'Lewisham', 'country': 'United Kingdom', 'facility': 'Lewisham Helathcare NHS Trust', 'geoPoint': {'lat': 51.46431, 'lon': -0.01193}}, {'zip': 'SE5 9RS', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Kings College Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SW17 0RE', 'city': 'London', 'country': 'United Kingdom', 'facility': 'St Georges Hospital London', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'CT9 4AN', 'city': 'Margate', 'country': 'United Kingdom', 'facility': 'Queen Elizabeth Queen Mother Hospital', 'geoPoint': {'lat': 51.38132, 'lon': 1.38617}}, {'zip': 'LA1 4RP', 'city': 'Morecambe', 'country': 'United Kingdom', 'facility': 'University Hospitals of Morecambe Bay', 'geoPoint': {'lat': 54.06835, 'lon': -2.86108}}, {'zip': 'NR4 7UY', 'city': 'Norwich', 'country': 'United Kingdom', 'facility': 'Norfolk and Norwich University', 'geoPoint': {'lat': 52.62783, 'lon': 1.29834}}, {'zip': 'PO6 3LY', 'city': 'Portsmouth', 'country': 'United Kingdom', 'facility': 'Portsmouth Hospitals NHS Trust', 'geoPoint': {'lat': 50.79899, 'lon': -1.09125}}, {'zip': 'BN8 7UB', 'city': 'Redditch', 'country': 'United Kingdom', 'facility': 'Worcestershire Acute Hospitals', 'geoPoint': {'lat': 52.3065, 'lon': -1.94569}}, {'zip': 'RH1 5RH', 'city': 'Redhill', 'country': 'United Kingdom', 'facility': 'East Surrey Hospital', 'geoPoint': {'lat': 51.24048, 'lon': -0.17044}}, {'zip': 'ME16 9QQ', 'city': 'Royal Tunbridge Wells', 'country': 'United Kingdom', 'facility': 'Maidstone and Tunbridge Wells NHS Trust', 'geoPoint': {'lat': 51.13321, 'lon': 0.26256}}, {'zip': 'SO16 6YD', 'city': 'Southampton', 'country': 'United Kingdom', 'facility': 'University Hospital Southampton', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}, {'zip': 'BA21 4AT', 'city': 'Yeovil', 'country': 'United Kingdom', 'facility': 'Yeovil District Hospital', 'geoPoint': {'lat': 50.94159, 'lon': -2.63211}}], 'overallOfficials': [{'name': 'Chakravarthi Rajkumar', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Sussex'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sussex', 'class': 'OTHER'}, 'collaborators': [{'name': 'Danone Institute International', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2022-05-18', 'type': 'RELEASE'}, {'date': '2023-02-21', 'type': 'RESET'}], 'unpostedResponsibleParty': 'University of Sussex'}}}}