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.

Study Overview

• Status: Unknown
• Conditions: Diarrhea
• Intervention / Treatment: Drug: Lactoferrin

• Study Type: Interventional
• Enrollment (Anticipated): 340
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Masking: Double

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Reduction in the number of days of antibiotic associated diarrhea during the treatment period

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Anticipated): September 1, 2013
• Study Completion (Anticipated): March 1, 2014

Study Registration Dates

• First Submitted: June 21, 2011
• First Submitted That Met QC Criteria: June 23, 2011
• First Posted (Estimate): June 27, 2011

Study Record Updates

• Last Update Posted (Estimate): June 27, 2011
• Last Update Submitted That Met QC Criteria: June 23, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: Antibiotic Associated Diarrhea in Adult Patients
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Diarrhea; Anti-Infective Agents; Lactoferrin
• Other Study ID Numbers: VB-Ven100-2011-01; R44AG037211 (U.S. NIH Grant/Contract)