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

Hadassah Medical Center

Status and phase: Unknown; Phase 3

Conditions: Diarrhea; Clostridium Difficile

Treatments: Drug: Placebo; Drug: probiotic mixture

Study type: Interventional

Funder types: Other

Identifiers

NCT00506181

probiotics-HMO-CTIL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

120 participants in 3 patient groups, including a placebo group

X

Active Comparator group

Description:

receiving probiotics

Treatment:

Drug: probiotic mixture

Y

Placebo Comparator group

Treatment:

Drug: Placebo

Z

No Intervention group