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Novel Prebiotic Fiber as Targeted Dietary Management of Irritable Bowel Syndrome

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
Program Year/Program:
2013 / SBIR
Agency Tracking Number:
R44DK088525
Solicitation Year:
2013
Solicitation Topic Code:
NIDDK
Solicitation Number:
PA12-088
Small Business Information
NUTRABIOTIX, LLC
1281 Win Hentschel Blvd. WEST LAFAYETTE, IN 47906-1075
View profile »
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 2
Fiscal Year: 2013
Title: Novel Prebiotic Fiber as Targeted Dietary Management of Irritable Bowel Syndrome
Agency: HHS
Contract: 2R44DK088525-02
Award Amount: $2,563,560.00
 

Abstract:

DESCRIPTION (provided by applicant): The objective of this Phase II SBIR application is to test NTX-1 fiber in patients with constipation-predominant IBS (IBS-C) and determine if it can reduce symptoms, beneficially modify gut microbiota composition, and improve gut milieu in these patients. Our hypothesis for the Phase II study is that NTX-1 fiber is better tolerated (i.e. has less side effects) and is more effective than psyllium (the most commonly used fiber in US) for symptom improvement and is effective in correcting the abnormal colonic milieu in those with dysbiosis and low SCFA (short chain fatty acid) levels. To this end, we propose to conduct an 18-week (2-week initial run-in phase, 12-week treatment phase, and 4-week follow up phase), 2-arm, randomized, double-blind, controlled Phase 2 trial in 120 patients with IBS-C. PUBLIC HEALTH RELEVANCE PUBLIC HEALTH RELEVANCE: The completion of this project will prove the efficacy and tolerability of Nutrabiotix Fiber in humans as a medical foodfor the specific nutritional needs of IBS-C patients and will form the basis of commercializing a well-tolerated natural carbohydrate product as a medical food with targeted delivery to the colon that promotes digestive health.

Principal Investigator:

Mark Cisneros
765-807-0778
mark.cisneros@nutrabiotix.com

Business Contact:

Mark D. Cisneros
765-807-0778
mark.cisneros@nutrabiotix.com
Small Business Information at Submission:

NUTRABIOTIX, LLC
1281 Win Hentschel Blvd. WEST LAFAYETTE, IN 47906-1075

EIN/Tax ID: 126020829
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No