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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: National Institutes of Health
Contract: 2R44DK088525-02
Agency Tracking Number: R44DK088525
Amount: $2,563,560.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NIDDK
Solicitation Number: PA12-088
Solicitation Year: 2013
Award Year: 2013
Award Start Date (Proposal Award Date): N/A
Award End Date (Contract End Date): N/A
Small Business Information
1281 Win Hentschel Blvd.
United States
DUNS: 826373792
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (765) 807-0778
Business Contact
Phone: (765) 807-0778
Research Institution

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.

* Information listed above is at the time of submission. *

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