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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

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diarrhea Drug: Lactoferrin Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 340 participants
Allocation: Randomized
Masking: Double
Primary Purpose: Prevention
Official Title: 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
Study Start Date : September 2011
Estimated Primary Completion Date : September 2013
Estimated Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Diarrhea

Arm Intervention/treatment
Experimental: Ven100
Recombinant Human Lactoferrin Administered Orally for the Prevention of Antibiotic Associated Diarrhea in Adult Patients
Drug: Lactoferrin



Primary Outcome Measures :
  1. Reduction in the number of days of antibiotic associated diarrhea during the treatment period


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01382199


Sponsors and Collaborators
Ventria Bioscience
National Institute on Aging (NIA)
Investigators
Study Director: Ning Huang, Ph.D. Ventria Bioscience

Responsible Party: Dr. Ning Huang, Vice President Research & Development, Ventria Bioscience
ClinicalTrials.gov Identifier: NCT01382199     History of Changes
Other Study ID Numbers: VB-Ven100-2011-01
R44AG037211 ( U.S. NIH Grant/Contract )
First Posted: June 27, 2011    Key Record Dates
Last Update Posted: June 27, 2011
Last Verified: June 2011

Keywords provided by Ventria Bioscience:
Antibiotic Associated Diarrhea in Adult Patients

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Anti-Bacterial Agents
Antibiotics, Antitubercular
Lactoferrin
Anti-Infective Agents
Antitubercular Agents