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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2007 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
Information provided by:
Hadassah Medical Organization Identifier:
First received: July 22, 2007
Last updated: July 23, 2007
Last verified: July 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 Intervention Phase
Diarrhea Clostridium Difficile Drug: probiotic mixture Drug: Placebo Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Hadassah Medical Organization:

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

Estimated Enrollment: 120
Study Start Date: July 2007
Estimated Study Completion Date: July 2008
Arms Assigned Interventions
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

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00506181

Contact: Elchanan Fried, MD 00972508573453
Contact: Hadas Lemberg, PhD 00 972 2 6777572

Hadassah Medical Organization, Jerusalem, Israel Recruiting
Jerusalem, Israel
Contact: Arik Tzukert, DMD    00 972 2 6776095   
Contact: Hadas Lemberg, PhD    00 972 2 6777572   
Principal Investigator: Elchanan Fried, MD         
Sponsors and Collaborators
Hadassah Medical Organization
Principal Investigator: Elchanan Fried, MD Hadassah Medical Organization
  More Information Identifier: NCT00506181     History of Changes
Other Study ID Numbers: probiotics-HMO-CTIL
Study First Received: July 22, 2007
Last Updated: July 23, 2007

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms processed this record on August 17, 2017