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Lactoferrin for the prevention of antibiotic-associated diarrhea in adult

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
Program Year/Program:
2011 / SBIR
Agency Tracking Number:
R44AG037211
Solicitation Year:
2011
Solicitation Topic Code:
NIA
Solicitation Number:
PA09-080
Small Business Information
VENTRIA BIOSCIENCE
320 East Vine Drive FORT COLLINS, CO -
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Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 2
Fiscal Year: 2011
Title: Lactoferrin for the prevention of antibiotic-associated diarrhea in adult
Agency: HHS
Contract: 4R44AG037211-02
Award Amount: $842,421.00
 

Abstract:

DESCRIPTION (provided by applicant): Patients treated with antibiotics frequently develop diarrhea. In developed countries, adults, particularly the elderly, experience a higher death rate due to diarrhea than children. Results from in vitro and preliminary in vivo studies lead us to hypothesize that oral administration of recombinant human lactoferrin as a medical food might be able to prevent and reduce antibiotic associated diarrhea in adults. The present fast track SBIR Phase I and II proposal plans totest this hypothesis with a clinical trial involving 260 subjects. In phase I, we will produce 25 kg of testing materials, recombinant human lactoferrin, from rice grain and at the same time obtain IRB approval of the clinical trial. In phase II, we will conduct the clinical study in four test sites in Baltimore. We expect that the study will prove that recombinant human lactoferrin is able to reduce incidence of antibiotic associated diarrhea by 50% and if patients do get diarrhea, the diarrhea days will be shorten by half. PUBLIC HEALTH RELEVANCE: The high death rate associated with diarrhea in adults compared to that in children in developed countries is commonly neglected. Oral administration of recombinant human lactoferrin might be able to prevent antibiotic associated diarrhea in adults and the present proposal is to test this hypothesis.

Principal Investigator:

Ning Huang
916-838-3467
NHUANG@VENTRIA.COM

Business Contact:

Ning Huang
916-921-6148
nhuang@ventria.com
Small Business Information at Submission:

VENTRIA BIOSCIENCE
320 East Vine Drive FORT COLLINS, CO -

EIN/Tax ID: 168031084
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No