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Safety and Validation of Efficacy of Oral Administration of the Food Additive Colostrum Derived Anti Clostridium Difficile Antibodies

NCT ID: NCT00747071

Last Updated: 2012-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2/PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2013-11-30

Brief Summary

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This clinical study is designed to evaluate the safety and efficacy of oral administration of the food additive colostrum derived antibodies to Clostridium difficile for prevention of Clostridium difficile associated disease (CDAD).

Detailed Description

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Conditions

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Clostridium Difficile-Associated Diarrhea

Keywords

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Clostridium difficile diarrhea colostrum

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Hospitalized patients with Clostridium difficile associated diarrhea.

Group Type EXPERIMENTAL

Colostrum

Intervention Type DRUG

Daily administration of Colostrum derived antibodies against C. difficile.

2

Close hospital contacts of each index case

Group Type EXPERIMENTAL

Colostrum

Intervention Type DRUG

Daily administration of Colostrum derived antibodies against C. difficile.

Interventions

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Colostrum

Daily administration of Colostrum derived antibodies against C. difficile.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age 18 or older
* Written informed consent
* At least 3 unformed or watery stools in each of the 2 previous 24 hour periods.
* Confirmed diagnosis of C. difficile associated diarrhea

Exclusion Criteria

* Pregnant or breast feeding women
* Known allergy to milk or milk products
* Other etiology of diarrhea
* Active or Chronic conditions: IBD, short bowel syndrome, ischemic colitis Ileus
* Pseudomembranous colitis
* White blood count \> 50,000
* Blood in stools
* Laxatives or motility drugs within 12 hours
* Inability to participate in adequate follow up
* Clinically unstable
* Investigator deems unsuitable
* Immune suppression (disease or treatment)
* GI surgery
* Past intestinal parasites
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Responsible Party

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Hadassah Medical Center

Locations

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Hadassah Medical Organization

Jerusalem, , Israel

Site Status

Countries

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Israel

Other Identifiers

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0180-08-HMO - CTIL

Identifier Type: -

Identifier Source: org_study_id