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

Diarrhea Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00506181
• Other study ID #: probiotics-HMO-CTIL
• Status: Not yet recruiting
• Phase: Phase 3
• First received: July 22, 2007
• Last updated: July 23, 2007
• Start date: July 2007
• Est. completion date: July 2008

Study information

• Verified date: July 2007
• Source: Hadassah Medical Organization
• Contact: Elchanan Fried, MD
• Phone: 00972508573453
• Email: elchananf[@]hadassah.org.il
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Clostridium Difficile
• Diarrhea

Intervention

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

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization, Jerusalem, Israel	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of AAD & CDT, and thus less hospitalization days and lower costs.		one year