Probiotics: is it Really That Good? Cost-Effectiveness of Treating the in-Patient
|ClinicalTrials.gov Identifier: NCT00506181|
Recruitment Status : Unknown
Verified July 2007 by Hadassah Medical Organization.
Recruitment status was: Not yet recruiting
First Posted : July 25, 2007
Last Update Posted : July 25, 2007
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.
|Condition or disease||Intervention/treatment||Phase|
|Diarrhea Clostridium Difficile||Drug: probiotic mixture Drug: Placebo||Phase 3|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||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|
|Study Start Date :||July 2007|
|Estimated Study Completion Date :||July 2008|
Active Comparator: X
Drug: probiotic mixture
"Jarro-Dophilus" probiotic mixture (4,400,000,000 bacteria in each capsule). One capsule X2/day.
|Placebo Comparator: Y||Drug: Placebo|
|No Intervention: Z|
- Reduction of AAD & CDT, and thus less hospitalization days and lower costs. [ Time Frame: one year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00506181
|Contact: Elchanan Fried, MDemail@example.com|
|Contact: Hadas Lemberg, PhD||00 972 2 firstname.lastname@example.org|
|Hadassah Medical Organization, Jerusalem, Israel||Recruiting|
|Contact: Arik Tzukert, DMD 00 972 2 6776095 email@example.com|
|Contact: Hadas Lemberg, PhD 00 972 2 6777572 firstname.lastname@example.org|
|Principal Investigator: Elchanan Fried, MD|
|Principal Investigator:||Elchanan Fried, MD||Hadassah Medical Organization|