Probiotics: is it Really That Good? Cost-Effectiveness of Treating the in-Patient
Recruitment status was Not yet recruiting
|First Received Date ICMJE||July 22, 2007|
|Last Updated Date||July 23, 2007|
|Start Date ICMJE||July 2007|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Reduction of AAD & CDT, and thus less hospitalization days and lower costs. [ Time Frame: one year ]|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00506181 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Probiotics: is it Really That Good? Cost-Effectiveness of Treating the in-Patient|
|Official Title ICMJE||Phase 3 Study of Probiotics, to Provide a Legitimate Reason for the Administration of Probiotic Therapy in the Hospitalized Patient, Particularly in Patients on Antibiotic Therapy|
Medical literature has dealt with various perspectives of probiotic therapy - prevention of antibiotic associated diarrhoea, Clostridium difficile, etc.
However, there have been no published results which can provide a basis for a generalized recommendation or discouragement of probiotic use among various groups of hospitalized patients.
The hypothesis is that the benefit in probiotic therapy in the admitted patient is by far larger than the actual cost of therapy. This assumption is probably true for all admitted patients and for patients on antibiotic therapy in particular.
Probiotics are known as a food supplement available worldwide as an OTC drug, with minimal side effects. Probiotics have also been recommended as a food supplement to patients suffering of antibiotic side effects and to those suffering of IBD or IBS.
All patients admitted to Internal Medicine and the Medical Intensive Care Unit will be randomly divided in a double blind fashion into two groups. Group One will be provided with the probiotic mixture - one capsule, two times per day. Group Two will receive a placebo. Group Three will receive no therapy.
Objective parameters such as duration of hospital stay, mortality and diarrhea frequency will be recorded. In addition, the frequency of CDT as well as blood and urine cultures will be examined. Furthermore, subjective measures will be examined by use of a questionnaire to be filled by the patient and/or his/her family members, or by the treating nurse.
Later the data will be processed and analyzed to compare between all the study participants and between the subgroups of the study (i.e. patients on specific antibiotic therapies).
For each patient, the experiment will last throughout his/her entire hospital stay.
The study is to last for one year and until 120 patients have participated.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 3|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
|Study Arm (s)||
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Not yet recruiting|
|Estimated Enrollment ICMJE||120|
|Estimated Completion Date||July 2008|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Location Countries ICMJE||Israel|
|NCT Number ICMJE||NCT00506181|
|Other Study ID Numbers ICMJE||probiotics-HMO-CTIL|
|Has Data Monitoring Committee||No|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Hadassah Medical Organization|
|Collaborators ICMJE||Not Provided|
|Information Provided By||Hadassah Medical Organization|
|Verification Date||July 2007|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP