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

Hadassah Medical Center

Status and phase: Withdrawn; Phase 3; Phase 2

Conditions: Clostridium Difficile-Associated Diarrhea

Treatments: Drug: Colostrum

Study type: Interventional

Funder types: Other

Identifiers

NCT00747071

0180-08-HMO - CTIL

Details and patient eligibility

About

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).

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups

1

Experimental group

Description:

Hospitalized patients with Clostridium difficile associated diarrhea.

Treatment:

Drug: Colostrum

2

Experimental group

Description:

Close hospital contacts of each index case

Treatment:

Drug: Colostrum