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

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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
Sponsor:
Information provided by:

Study Description
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.


Condition or disease Intervention/treatment Phase
Diarrhea Clostridium Difficile Drug: probiotic mixture Drug: Placebo Phase 3

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: X
receiving probiotics
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


Outcome Measures

Primary Outcome Measures :
  1. Reduction of AAD & CDT, and thus less hospitalization days and lower costs. [ Time Frame: one year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00506181


Contacts
Contact: Elchanan Fried, MD 00972508573453 elchananf@hadassah.org.il
Contact: Hadas Lemberg, PhD 00 972 2 6777572 lhadas@hadassah.org.il

Locations
Israel
Hadassah Medical Organization, Jerusalem, Israel Recruiting
Jerusalem, Israel
Contact: Arik Tzukert, DMD    00 972 2 6776095    arik@hadassah.org.il   
Contact: Hadas Lemberg, PhD    00 972 2 6777572    lhadas@hadassah.org.il   
Principal Investigator: Elchanan Fried, MD         
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Elchanan Fried, MD Hadassah Medical Organization
More Information

ClinicalTrials.gov Identifier: NCT00506181     History of Changes
Other Study ID Numbers: probiotics-HMO-CTIL
First Posted: July 25, 2007    Key Record Dates
Last Update Posted: July 25, 2007
Last Verified: July 2007

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms