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

NCT01382199 | Unknown Phase 3 DMC

• 2 other identifiers: VB-Ven100-2011-01R44AG037211
• Study Type: interventional
• Target: 340
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diarrhea

Keywords

Antibiotic Associated Diarrhea in Adult Patients

Outcome Measures

Primary Outcomes (1)

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

Study Arms (1)

Ven100

EXPERIMENTAL

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

Drug: Lactoferrin

Interventions

Lactoferrin DRUG

Ven100

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients 50 years of age and older.
• Resident of a participating long term care facility.
• Able to consume 30 mL of liquid solution two time per day by mouth or enteral feeding tube.
• Patient has had no antibiotics in the 4 weeks preceding enrollment in the study.
• Patient has been started on a broad spectrum antibiotic(s) for an infection other than gastroenteritis.
• Patient has a life expectancy greater than 6 months.
• Patient or health care agent is able and willing to sign a written informed consent.
• 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.

You may not qualify if:

• Patient has an ileostomy.
• Patient has a prior history of major gastrointestinal surgery such as partial small bowel or colon resection or gastric bypass.
• Patient has a history of inflammatory bowel disease.
• Patient has a history of chronic diarrhea associated with irritable bowel syndrome or other etiologies.
• Patient has a history of severe constipation requiring use of enemas or disimpaction within 30 days prior to enrollment.
• Patient has signs or symptoms of C. difficile infection including diarrhea.
• Patient has signs or symptoms of acute or chronic diarrhea.
• Patient has known sensitivity or allergy to rice or rice products.
• Patient has significant medical problems which in the judgment of the principal investigator or medical monitor may interfere with participation in the study.
• Patient is not receiving an antibiotic regimen consisting of a broad spectrum antibiotic.
• Patient has participated in an investigational study using an investigational product within 30 days of randomization.

Sponsors & Collaborators

• Ventria Bioscience: lead
• National Institute on Aging (NIA): collaborator

MeSH Terms

Conditions

Diarrhea

Interventions

Lactoferrin

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Glycoproteins; Glycoconjugates; Carbohydrates; Transferrins; Iron-Binding Proteins; Carrier Proteins; Proteins; Amino Acids, Peptides, and Proteins; Lactoglobulins; Whey Proteins; Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Globulins; Metalloproteins

Study Officials

• Ning Huang, Ph.D.

  Ventria Bioscience

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 21, 2011
• First Posted: June 27, 2011
• Study Start: September 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: March 1, 2014
• Last Updated: June 27, 2011

Record last verified: 2011-06