Probiotics in Preventing Antibiotic Associated Diarrhoea Including Clostridium Difficile Infection (NU278)

• ClinicalTrials.gov Identifier: NCT01087892
• Recruitment Status: Completed
• First Posted: March 16, 2010
• Last Update Posted: March 30, 2020
• Sponsor: University of Sussex
• Collaborator: Danone Institute International
• Information provided by (Responsible Party): University of Sussex

Tracking Information

• First Submitted Date: March 15, 2010
• First Posted Date: March 16, 2010
• Last Update Posted Date: March 30, 2020
• Study Start Date: October 2009
• Actual Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 21, 2014)

The incidence of diarrhoea [ Time Frame: regular intervals for 28days from entry to trial ]

The incidence of antibiotic associated diarrhoea in the active and placebo group by the end of the follow up period

• Original Primary Outcome Measures (submitted: March 15, 2010): Incidence of diarrhoea [ Time Frame: regular intervals for 28days from entry to trial ]

Current Secondary Outcome Measures (submitted: March 15, 2010)

• incidence and duration of Clostridium difficile toxin [ Time Frame: regular intervals for 28 days from entry to trial ]
  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 ]
  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 ]
  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 ]
• 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 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Probiotics in Preventing Antibiotic Associated Diarrhoea Including Clostridium Difficile Infection
• Official Title: Probiotics in Preventing Antibiotic Associated Diarrhoea Including Clostridium Difficile Infection
• Brief Summary: 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.
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention

Condition

• Diarrhoea
• Clostridium Difficile

Intervention

• Dietary Supplement: Probiotic drink containing the live strain
  Probiotic drink contains no strain
• Dietary Supplement: placebo probiotic
  Placebo product is a sweetened flavoured, non fermented, acidified dairy drink

Study Arms

• Active Comparator: Dietary supplement Probiotic drink

  Double blind

  Probiotic containing the live strain 100g/day orally, twice daily for the duration of the course of antibiotics plus seven days

  Intervention: Dietary Supplement: Probiotic drink containing the live strain
• Placebo Comparator: Dietary supplement probiotic placebo drink

  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

  Intervention: Dietary Supplement: placebo probiotic

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 21, 2014): 1126
• Original Estimated Enrollment (submitted: March 15, 2010): 1200
• Actual Study Completion Date: September 2013
• Actual Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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

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 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 55 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT01087892
• Other Study ID Numbers: UKCRN7582
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: University of Sussex
• Original Responsible Party: Professor Rajkumar, Brighton and Sussex Medical School
• Current Study Sponsor: University of Sussex
• Original Study Sponsor: Same as current
• Collaborators: Danone Institute International

Investigators

• Study Chair: Chakravarthi Rajkumar; University of Sussex

• PRS Account: University of Sussex
• Verification Date: March 2020