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

Primary Purpose

Clostridium Difficile-Associated Diarrhea

Status
Withdrawn
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Colostrum
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Clostridium Difficile-Associated Diarrhea focused on measuring Clostridium difficile, diarrhea, colostrum

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hadassah Medical Organization

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

Hospitalized patients with Clostridium difficile associated diarrhea.

Close hospital contacts of each index case

Outcomes

Primary Outcome Measures

Recurrence of active Clostridium difficile associated diarrhea in index cases
New cases of Clostridium difficile associated diarrhea in close hospital contacts.

Secondary Outcome Measures

Disease severity - duration, maximal intensity (number of stools) in index cases.
Eradication of Clostridium difficile from stools

Full Information

First Posted
September 3, 2008
Last Updated
August 27, 2012
Sponsor
Hadassah Medical Organization
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1. Study Identification

Unique Protocol Identification Number
NCT00747071
Brief Title
Safety and Validation of Efficacy of Oral Administration of the Food Additive Colostrum Derived Anti Clostridium Difficile Antibodies
Official Title
Safety and Validation of Efficacy of Oral Administration of the Food Additive Colostrum Derived Anti Clostridium Difficile Antibodies
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Withdrawn
Why Stopped
Sponsors decision
Study Start Date
September 2011 (undefined)
Primary Completion Date
November 2012 (Anticipated)
Study Completion Date
November 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Hadassah Medical Organization

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clostridium Difficile-Associated Diarrhea
Keywords
Clostridium difficile, diarrhea, colostrum

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Hospitalized patients with Clostridium difficile associated diarrhea.
Arm Title
2
Arm Type
Experimental
Arm Description
Close hospital contacts of each index case
Intervention Type
Drug
Intervention Name(s)
Colostrum
Intervention Description
Daily administration of Colostrum derived antibodies against C. difficile.
Primary Outcome Measure Information:
Title
Recurrence of active Clostridium difficile associated diarrhea in index cases
Time Frame
60 days
Title
New cases of Clostridium difficile associated diarrhea in close hospital contacts.
Time Frame
60 days
Secondary Outcome Measure Information:
Title
Disease severity - duration, maximal intensity (number of stools) in index cases.
Time Frame
60 days
Title
Eradication of Clostridium difficile from stools
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hadassah Medical Organization
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel

12. IPD Sharing Statement

Learn more about this trial

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

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