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| ID | Type | Description | Link |
|---|---|---|---|
| EUDRACT 2008-005244-16 |
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| Name | Class |
|---|---|
| Wrightington, Wigan and Leigh NHS Foundation Trust | OTHER |
| Ferring Pharmaceuticals | INDUSTRY |
| South London and Maudsley NHS Foundation Trust | OTHER |
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The investigators aim to investigate whether the routine use of the probiotic formulation VSL#3 co-prescribed with antibiotics reduces the incidence of both Antibiotic associated diarrhoea and Clostridium Difficile associated diarrhoea.
The investigators aim to find out whether VSL#3 can prevent Antibiotic associated diarrhoea and Clostridium Difficile associated diarrhoea when VSL#3 is giving during a course of systemic antibiotics. Patients will be randomized in a 1:1 proportion to receive either one sachet of VSL#3 or a similar looking placebo twice a day. This will be given for the length of the antibiotic course and another week thereafter. Follow-up will last until 28 days after the last antibiotic dose. Patient restarted on antibiotics during follow-up will be restarted on the trial medication and the 28 day follow-up will be recommenced.
This trial has 2 co-primary outcome measures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VSL#3 | Active Comparator | Patients will receive one VSL #3 sachets twice a day for the duration of the antibiotic course and for one week after. |
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| Placebo | Placebo Comparator | Patients will one placebo sachet twice a day for the duration of the antibiotic course and for one week after. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VSL#3 | Drug | Patients will o receive one VSL #3 sachets twice a day for the duration of the antibiotic course and for one week after. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Development of antibiotic associated diarrhoea | 28 days post last antibiotic dose | |
| Development of Clostridium difficile associated diarrhoea | 28 days post last antibiotic dose |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Hospital Stay | 28 days post last antibiotic dose | |
| 30-day Mortality | 30 days after initiation of therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Neil Haslam | Wirghtington Wigan and Leigh NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Albert Edward Infirmary | Wigan | Lancashire | WN1 2NN | United Kingdom | ||
| Queen Elizabeth Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11118872 | Background | Bergogne-Berezin E. Treatment and prevention of antibiotic associated diarrhea. Int J Antimicrob Agents. 2000 Dec;16(4):521-6. doi: 10.1016/s0924-8579(00)00293-4. | |
| 12052801 | Background | D'Souza AL, Rajkumar C, Cooke J, Bulpitt CJ. Probiotics in prevention of antibiotic associated diarrhoea: meta-analysis. BMJ. 2002 Jun 8;324(7350):1361. doi: 10.1136/bmj.324.7350.1361. |
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| North Bristol NHS Trust |
| OTHER |
| Hull University Teaching Hospitals NHS Trust | OTHER_GOV |
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| Placebo | Drug | Patients will one placebo sachet twice a day for the duration of the antibiotic course and for one week after. |
|
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| Woolwich |
| London |
| SE18 4QH |
| United Kingdom |
| Frenchay Hospital | Bristol | BS16 1LE | United Kingdom |
| Hull Royal Infirmary | Hull | HU3 2JZ | United Kingdom |
| Weston General Hospital | Weston-super-Mare | BS23 4TQ | United Kingdom |
| 12182746 | Background | Cremonini F, Di Caro S, Nista EC, Bartolozzi F, Capelli G, Gasbarrini G, Gasbarrini A. Meta-analysis: the effect of probiotic administration on antibiotic-associated diarrhoea. Aliment Pharmacol Ther. 2002 Aug;16(8):1461-7. doi: 10.1046/j.1365-2036.2002.01318.x. |
| 23618760 | Result | Selinger CP, Bell A, Cairns A, Lockett M, Sebastian S, Haslam N. Probiotic VSL#3 prevents antibiotic-associated diarrhoea in a double-blind, randomized, placebo-controlled clinical trial. J Hosp Infect. 2013 Jun;84(2):159-65. doi: 10.1016/j.jhin.2013.02.019. Epub 2013 Apr 22. |
| ID | Term |
|---|---|
| D003967 | Diarrhea |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C100843 | Lacteol |
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