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Probiotics: is it Really That Good? Cost-Effectiveness of Treating the in-Patient

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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00506181
Enrollment
120
Registered
2007-07-25
Start date
2007-07-31
Completion date
2008-07-31
Last updated
2007-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clostridium Difficile, Diarrhea

Brief summary

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.

Detailed description

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.

Interventions

Jarro-Dophilus probiotic mixture (4,400,000,000 bacteria in each capsule). One capsule X2/day.

DRUGPlacebo

Sponsors

Hadassah Medical Organization
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* All patients hospitalized in the Department of Internal Medicine for a minimum duration of 3 days. * Age (all \>18) and gender are to have no impact on the usage of the drug.

Exclusion criteria

* patients who do not agree to participate in the study * patients on an NPO (nothing per os) order, if NPO includes medications * patients who suffer of Celiac disease

Design outcomes

Primary

MeasureTime frame
Reduction of AAD & CDT, and thus less hospitalization days and lower costs.one year

Countries

Israel

Contacts

Primary ContactElchanan Fried, MD
elchananf@hadassah.org.il00972508573453
Backup ContactHadas Lemberg, PhD
lhadas@hadassah.org.il00 972 2 6777572

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026