Probiotics: is it Really That Good? Cost-Effectiveness of... | NCT00506181

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

NCT00506181

Sponsor

Hadassah Medical Organization

Status

Unknown status

Last Update Posted

Jul 25, 2007Estimated

Enrollment

120Estimated

Phase

Phase 3

Conditions

Diarrhea
Clostridium Difficile

Interventions

probiotic mixture
Placebo

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2007

Primary Completion Date

Not provided

Completion Date

Jul 2008Estimated

First Submitted Date

Jul 22, 2007

First Submission Date that Met QC Criteria

Jul 23, 2007

First Posted Date

Jul 25, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 23, 2007

Last Update Posted Date

Jul 25, 2007Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Hadassah Medical OrganizationOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
X	Active Comparator	receiving probiotics	Drug: probiotic mixture
Y	Placebo Comparator		Drug: Placebo
Z	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
probiotic mixture	Drug	"Jarro-Dophilus" probiotic mixture (4,400,000,000 bacteria in each capsule). One capsule X2/day.	X

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reduction of AAD & CDT, and thus less hospitalization days and lower costs.		one year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Elchanan Fried, MD	Contact	00972508573453		elchananf@hadassah.org.il
Hadas Lemberg, PhD	Contact	00 972 2 6777572		lhadas@hadassah.org.il

Overall Officials

Name	Affiliation	Role
Elchanan Fried, MD	Hadassah Medical Organization	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hadassah Medical Organization, Jerusalem, Israel		Jerusalem			Israel

Condition Browse Module

MeSH Terms

ID	Term
D003967	Diarrhea

Ancestor Terms

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

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Browse Branches

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