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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Ventria Bioscience.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Information provided by:
Ventria Bioscience
ClinicalTrials.gov Identifier:
NCT01382199
First received: June 21, 2011
Last updated: June 23, 2011
Last verified: June 2011
  Purpose

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 Intervention Phase
Diarrhea
Drug: Lactoferrin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Ventria Bioscience:

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

Estimated Enrollment: 340
Study Start Date: September 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ven100
Recombinant Human Lactoferrin Administered Orally for the Prevention of Antibiotic Associated Diarrhea in Adult Patients
Drug: Lactoferrin

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01382199

Sponsors and Collaborators
Ventria Bioscience
Investigators
Study Director: Ning Huang, Ph.D. Ventria Bioscience
  More Information

No publications provided

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
Study First Received: June 21, 2011
Last Updated: June 23, 2011
Health Authority: United States: Food and Drug Administration

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
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on September 18, 2014