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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01087892
Recruitment Status : Completed
First Posted : March 16, 2010
Last Update Posted : March 30, 2020
Sponsor:
Collaborator:
Danone Institute International
Information provided by (Responsible Party):
University of Sussex

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diarrhoea Clostridium Difficile Dietary Supplement: Probiotic drink containing the live strain Dietary Supplement: placebo probiotic Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Probiotics in Preventing Antibiotic Associated Diarrhoea Including Clostridium Difficile Infection
Study Start Date : October 2009
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Diarrhea

Arms and Interventions
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Arm Intervention/treatment
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

 Dietary Supplement: Probiotic drink containing the live strain
Probiotic drink contains no 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

 Dietary Supplement: placebo probiotic
Placebo product is a sweetened flavoured, non fermented, acidified dairy drink


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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 ]
  5. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01087892


Locations
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Sponsors and Collaborators
University of Sussex
Danone Institute International
Investigators
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Study Chair: Chakravarthi Rajkumar University of Sussex
More Information
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Responsible Party: University of Sussex
ClinicalTrials.gov Identifier: NCT01087892    
Other Study ID Numbers: UKCRN7582
First Posted: March 16, 2010    Key Record Dates
Last Update Posted: March 30, 2020
Last Verified: March 2020
Additional relevant MeSH terms:
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Clostridium Infections
Diarrhea
Infections
Signs and Symptoms, Digestive
 Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses