WithdrawnNCT00747071Updated Aug 28, 2012

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

A Phase 2/3 interventional study of Colostrum in Clostridium Difficile-Associated Diarrhea, sponsored by Hadassah Medical Organization. Withdrawn at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-08-28.

Sponsored by Hadassah Medical Organization · Phase 2/3, Interventional, and Prevention

Why this study was withdrawn

Sponsors decision

Phase: Phase 2/3
Study type: Interventional
Enrollment: 0
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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).

Conditions studied

Clostridium Difficile-Associated Diarrhea

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Keywords

Clostridium difficile
diarrhea
colostrum

In context

Clostridium Infections

310 studies on the registry are indexed under Clostridium Infections; 50 are open to participants now.

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Lead sponsor

Hadassah Medical Organization is the lead sponsor of 659 studies on the registry; 54 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Study design

Phase: Phase 2 / Phase 3
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Single group
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 0 participants (actual)

Study arms

Experimental
1
Hospitalized patients with Clostridium difficile associated diarrhea.
Drug: Colostrum
Experimental
2
Close hospital contacts of each index case
Drug: Colostrum

Interventions

DrugColostrum
Daily administration of Colostrum derived antibodies against C. difficile.

What researchers measure

Primary outcomes

Recurrence of active Clostridium difficile associated diarrhea in index cases
Time frame: 60 days
New cases of Clostridium difficile associated diarrhea in close hospital contacts.
Time frame: 60 days

Secondary outcomes

Disease severity - duration, maximal intensity (number of stools) in index cases.
Time frame: 60 days
Eradication of Clostridium difficile from stools
Time frame: 1 year

Study locations

1 site

Hadassah Medical Organization
Jerusalem, 91120, Israel

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 28, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00747071
Lead sponsor: Hadassah Medical Organization
First posted: Sep 4, 2008
Start date: Sep 2011
Primary completion: Nov 2012 (estimated)
Completion: Nov 2013 (estimated)
Last update: Aug 28, 2012

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.

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