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

NCT00506181 | Unknown Phase 3

• 1 other identifier: probiotics-HMO-CTIL
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Diarrhea; Clostridium Difficile

Outcome Measures

Primary Outcomes (1)

• Reduction of AAD & CDT, and thus less hospitalization days and lower costs.

  one year

Study Arms (3)

X

ACTIVE COMPARATOR

receiving probiotics

Drug: probiotic mixture

Y

PLACEBO COMPARATOR

Drug: Placebo

Z

NO INTERVENTION

Interventions

probiotic mixture DRUG

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

X

Placebo DRUG

Y

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Medical Organization, Jerusalem, Israel

Jerusalem, Israel

Location

MeSH Terms

Conditions

Diarrhea

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Elchanan Fried, MD

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elchanan Fried, MD

CONTACT

00972508573453; elchananf@hadassah.org.il

Hadas Lemberg, PhD

CONTACT

00 972 2 6777572; lhadas@hadassah.org.il

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 22, 2007
• First Posted: July 25, 2007
• Study Start: July 1, 2007
• Study Completion: July 1, 2008
• Last Updated: July 25, 2007

Record last verified: 2007-07

Locations

IL (1)