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

Diarrhea Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01382199
• Other study ID #: VB-Ven100-2011-01
• Secondary ID: R44AG037211
• Status: Not yet recruiting
• Phase: Phase 3
• First received: June 21, 2011
• Last updated: June 23, 2011
• Start date: September 2011
• Est. completion date: March 2014

Study information

• Verified date: June 2011
• Source: Ventria Bioscience
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 340
• Est. completion date: March 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diarrhea

Intervention

Drug:
• Lactoferrin

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Ventria Bioscience	National Institute on Aging (NIA)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in the number of days of antibiotic associated diarrhea during the treatment period