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Recombinant Human Lactoferrin Administered Orally for the Prevention of Antibiotic Associated Diarrhea in Adult Patients

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ClinicalTrials.gov Identifier: NCT01382199
Recruitment Status : Unknown
Verified June 2011 by Ventria Bioscience.
Recruitment status was:  Not yet recruiting
First Posted : June 27, 2011
Last Update Posted : June 27, 2011
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by:
Ventria Bioscience

June 21, 2011
June 27, 2011
June 27, 2011
September 2011
September 2013   (Final data collection date for primary outcome measure)
Reduction in the number of days of antibiotic associated diarrhea during the treatment period
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Recombinant Human Lactoferrin Administered Orally for the Prevention of Antibiotic Associated Diarrhea in Adult Patients
A Phase III Randomized, Double Blind, Placebo Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Recombinant Human Lactoferrin Administered Orally for the Prevention of Antibiotic Associated Diarrhea in Adult Patients
The purpose of the study is to Evaluate the Efficacy and Safety of Recombinant Human Lactoferrin Administered Orally for the Prevention of Antibiotic Associated Diarrhea in Adult Patients.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Masking: Double
Primary Purpose: Prevention
Diarrhea
Drug: Lactoferrin
Experimental: Ven100
Recombinant Human Lactoferrin Administered Orally for the Prevention of Antibiotic Associated Diarrhea in Adult Patients
Intervention: Drug: Lactoferrin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
340
Same as current
March 2014
September 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • All patients must meet all of the inclusion criteria listed below at the time of enrollment.

    1. Male and female patients 50 years of age and older.
    2. Resident of a participating long term care facility.
    3. Able to consume 30 mL of liquid solution two time per day by mouth or enteral feeding tube.
    4. Patient has had no antibiotics in the 4 weeks preceding enrollment in the study.
    5. Patient has been started on a broad spectrum antibiotic(s) for an infection other than gastroenteritis.
    6. Patient has a life expectancy greater than 6 months.
    7. Patient or health care agent is able and willing to sign a written informed consent.
    8. Patient or caregiver is able and willing to complete diary of daily bowel movement information (number, formed or unformed, time) during any portion of the 8 week study.

Exclusion Criteria:

  1. Patient has an ileostomy.
  2. Patient has a prior history of major gastrointestinal surgery such as partial small bowel or colon resection or gastric bypass.
  3. Patient has a history of inflammatory bowel disease.
  4. Patient has a history of chronic diarrhea associated with irritable bowel syndrome or other etiologies.
  5. Patient has a history of severe constipation requiring use of enemas or disimpaction within 30 days prior to enrollment.
  6. Patient has signs or symptoms of C. difficile infection including diarrhea.
  7. Patient has signs or symptoms of acute or chronic diarrhea.
  8. Patient has known sensitivity or allergy to rice or rice products.
  9. Patient has significant medical problems which in the judgment of the principal investigator or medical monitor may interfere with participation in the study.
  10. Patient is not receiving an antibiotic regimen consisting of a broad spectrum antibiotic.
  11. Patient has participated in an investigational study using an investigational product within 30 days of randomization.
Sexes Eligible for Study: All
50 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01382199
VB-Ven100-2011-01
R44AG037211 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
Dr. Ning Huang, Vice President Research & Development, Ventria Bioscience
Ventria Bioscience
National Institute on Aging (NIA)
Study Director: Ning Huang, Ph.D. Ventria Bioscience
Ventria Bioscience
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP