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| Name | Class |
|---|---|
| Danone Institute International | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dietary supplement Probiotic drink | Active Comparator | Double blind Probiotic containing the live strain 100g/day orally, twice daily for the duration of the course of antibiotics plus seven days |
|
| Dietary supplement probiotic placebo drink | Placebo Comparator | Double blind 'placebo' is actually a control product Placebo drink contains no strain 100gs orally, twice daily for the duration of the course of antibiotics plus seven days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic drink containing the live strain | Dietary Supplement | Probiotic drink contains no strain |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of diarrhoea | The incidence of antibiotic associated diarrhoea in the active and placebo group by the end of the follow up period | regular intervals for 28days from entry to trial |
| Measure | Description | Time Frame |
|---|---|---|
| incidence and duration of Clostridium difficile toxin | 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 | regular intervals for 28 days from entry to trial |
| The rate of recurrence of antibiotic associated diarrhoea in the active and placebo groups to the end of the follow up period |
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Inclusion Criteria:
Exclusion Criteria:
Subjects 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.
Any 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
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| Name | Affiliation | Role |
|---|---|---|
| Chakravarthi Rajkumar | University of Sussex | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ashford and St Peters Hospital | Ashford | KT 0PZ | United Kingdom | |||
| Blackpool Vicotria Hospital |
| Type | Date | Date Unknown |
|---|---|---|
| Release | May 18, 2022 | |
| Reset | Feb 21, 2023 |
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| placebo probiotic | Dietary Supplement | Placebo product is a sweetened flavoured, non fermented, acidified dairy drink |
|
The rate of recurrence of antibiotic associated diarrhoea in the active and placebo groups to the end of the follow up period |
| regular intervals for 28 days from entry to trial |
| rate of recurrence of Clostridium difficile toxin positive diarrhoea | 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 | regular intervals for 28 days from entry to trial |
| The quality of life in the active and placebo groups at enrollment into the study | regular intervals for 28 days from entry to trial |
| 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 | regular intervals for 28 days from entry to trial |
| Blackpool |
| FY3 8NR |
| United Kingdom |
| Royal Sussex County Hospital | Brighton | BN2 5BE | United Kingdom |
| Cambridge University Hospital Trust | Cambridge | CB2 2QQ | United Kingdom |
| Broomfield Hospital | Chelmsford | CM1 7HT | United Kingdom |
| St.Richards Hospital | Chichester | PO19 6SE | United Kingdom |
| Colchester Hospitals University | Colchester | CO4 5JL | United Kingdom |
| Ealing Hospital | Ealing | UB1 3HW | United Kingdom |
| Eastbourne District General Hospital | Eastbourne | BN21 2YS | United Kingdom |
| Frimley Park Hospital | Frimley | SW17 7HS | United Kingdom |
| Princess Royal Hospital | Haywards Heath | RH16 4EX | United Kingdom |
| Hillingdon Hospital | Hillingdon | UB8 3NN | United Kingdom |
| Lancashire Teaching Hospital | Lancaster | PR2 9HT | United Kingdom |
| University Hosppitals of Leicester | Leicester | LE2 7LX | United Kingdom |
| Lewisham Helathcare NHS Trust | Lewisham | SE13 6LH | United Kingdom |
| Kings College Hospital | London | SE5 9RS | United Kingdom |
| St Georges Hospital London | London | SW17 0RE | United Kingdom |
| Queen Elizabeth Queen Mother Hospital | Margate | CT9 4AN | United Kingdom |
| University Hospitals of Morecambe Bay | Morecambe | LA1 4RP | United Kingdom |
| Norfolk and Norwich University | Norwich | NR4 7UY | United Kingdom |
| Portsmouth Hospitals NHS Trust | Portsmouth | PO6 3LY | United Kingdom |
| Worcestershire Acute Hospitals | Redditch | BN8 7UB | United Kingdom |
| East Surrey Hospital | Redhill | RH1 5RH | United Kingdom |
| Maidstone and Tunbridge Wells NHS Trust | Royal Tunbridge Wells | ME16 9QQ | United Kingdom |
| University Hospital Southampton | Southampton | SO16 6YD | United Kingdom |
| Yeovil District Hospital | Yeovil | BA21 4AT | United Kingdom |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 18, 2022 | Feb 21, 2023 |
| 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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