Role of Probiotics in Preventing Antibiotic Associated Diarrhoea Including c.Difficile (NU278)
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Antibiotic Associated Diarrhoea Including c.Difficile |
Dietary Supplement: probiotic drink Dietary Supplement: probiotic placebo drink |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Role of Probiotics in Preventing Antibiotic Associated Diarrhoea Including c.Difficile |
- Incidence of diarrhoea [ Time Frame: regular intervals for 28days from entry to trial ] [ Designated as safety issue: No ]
- incidence and duration of Clostridium difficile toxin [ Time Frame: regular intervals for 28 days from entry to trial ] [ Designated as safety issue: No ]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
- The rate of recurrence of antibiotic associated diarrhoea in the active and placebo groups to the end of the follow up period [ Time Frame: regular intervals for 28 days from entry to trial ] [ Designated as safety issue: No ]The rate of recurrence of antibiotic associated diarrhoea in the active and placebo groups to the end of the follow up period
- rate of recurrence of Clostridium difficile toxin positive diarrhoea [ Time Frame: regular intervals for 28 days from entry to trial ] [ Designated as safety issue: No ]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
- The quality of life in the active and placebo groups at enrollment into the study [ Time Frame: regular intervals for 28 days from entry to trial ] [ Designated as safety issue: No ]
- 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 [ Time Frame: regular intervals for 28 days from entry to trial ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 1200 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | October 2012 |
| Estimated Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: probiotic live
This is the probiotic containing the live strain
|
Dietary Supplement: probiotic drink
probiotic drink containing active strain
|
|
placebo probiotic
'placebo' is actually a control product
|
Dietary Supplement: probiotic placebo drink
placebo drink
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 55 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Male/female patients, above 55 years of age Patient has given written informed consent 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
Exclusion Criteria:
- Age less than 55 years Pregnancy Patients on PEG feed. Diarrhoea on admission or within the preceding week Severe life-threatening illness Subjects in a situation that, in the investigator's opinion, could interfere with optimal participation in the present study (e.g. non dairy-products consumer) or could constitute a special risk for the subject 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 requiring general anaesthesia 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.
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 Patients at permanent residence in a residential or a nursing home Barthel's index < 15 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
Contacts and Locations| Contact: Professor C Rajkumar, mbbs, MD,PHD | 01273523360 | c.rajkumar@bsms.ac.uk |
| Contact: Jasmin Islam, MBBS, BSc | 01273 523362 | jasmin.islam@bsuh.nhs.uk |
| United Kingdom | |
| University of Sussex | Recruiting |
| Brighton, United Kingdom | |
| Contact: Dr Juliet Wright, MBBS, MRCP, MD 01273 3364 juliet.wright@bsuh.nhs.uk | |
More Information
No publications provided
| Responsible Party: | Professor Rajkumar, Brighton and Sussex Medical School |
| ClinicalTrials.gov Identifier: | NCT01087892 History of Changes |
| Other Study ID Numbers: | UKCRN7582 |
| Study First Received: | March 15, 2010 |
| Last Updated: | July 20, 2010 |
| Health Authority: | United Kingdom: Research Ethics Committee |
Additional relevant MeSH terms:
|
Diarrhea Signs and Symptoms, Digestive Signs and Symptoms Anti-Bacterial Agents |
Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013