Role of Probiotics in Preventing Antibiotic Associated Diarrhoea Including c.Difficile (NU278)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by University of Sussex.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Danone Institute International
Information provided by:
University of Sussex
ClinicalTrials.gov Identifier:
NCT01087892
First received: March 15, 2010
Last updated: July 20, 2010
Last verified: July 2010
  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

Resource links provided by NLM:


Further study details as provided by University of Sussex:

Primary Outcome Measures:
  • Incidence of diarrhoea [ Time Frame: regular intervals for 28days from entry to trial ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01087892

Contacts
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

Locations
United Kingdom
University of Sussex Recruiting
Brighton, United Kingdom
Contact: Dr Juliet Wright, MBBS, MRCP, MD    01273 3364    juliet.wright@bsuh.nhs.uk   
Sponsors and Collaborators
University of Sussex
Danone Institute International
  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
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on July 20, 2014