Lactoferrin for the prevention of antibiotic-associated diarrhea in adult

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$538,324.00
Award Year:
2010
Program:
SBIR
Phase:
Phase I
Contract:
1R44AG037211-01
Award Id:
95701
Agency Tracking Number:
AG037211
Solicitation Year:
n/a
Solicitation Topic Code:
NIA
Solicitation Number:
n/a
Small Business Information
VENTRIA BIOSCIENCE, 320 East Vine Drive, FORT COLLINS, CO, 80524
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
932816929
Principal Investigator:
NING HUANG
(530) 792-1419
NHUANG@VENTRIA.COM
Business Contact:
NING HUANG
() -
nhuang@ventria.com
Research Institution:
n/a
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 preliminar y 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 to test 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 c onduct 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 b e 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 preve nt antibiotic associated diarrhea in adults and the present proposal is to test this hypothesis.

* information listed above is at the time of submission.

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