Probiotics: is it Really That Good? Cost-Effectiveness of Treating the in-Patient
NCT ID: NCT00506181
Last Updated: 2007-07-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
120 participants
INTERVENTIONAL
2007-07-31
2008-07-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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X
receiving probiotics
probiotic mixture
"Jarro-Dophilus" probiotic mixture (4,400,000,000 bacteria in each capsule). One capsule X2/day.
Y
Placebo
Z
No interventions assigned to this group
Interventions
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probiotic mixture
"Jarro-Dophilus" probiotic mixture (4,400,000,000 bacteria in each capsule). One capsule X2/day.
Placebo
Eligibility Criteria
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Inclusion Criteria
* Age (all \>18) and gender are to have no impact on the usage of the drug.
Exclusion Criteria
* patients on an NPO (nothing per os) order, if NPO includes medications
* patients who suffer of Celiac disease
18 Years
ALL
No
Sponsors
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Hadassah Medical Organization
OTHER
Principal Investigators
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Elchanan Fried, MD
Role: PRINCIPAL_INVESTIGATOR
Hadassah Medical Organization
Locations
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Hadassah Medical Organization, Jerusalem, Israel
Jerusalem, , Israel
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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probiotics-HMO-CTIL
Identifier Type: -
Identifier Source: org_study_id