Novel Prebiotic Fiber as Targeted Dietary Management of Irritable Bowel Syndrome

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$2,563,560.00
Award Year:
2013
Program:
SBIR
Phase:
Phase II
Contract:
2R44DK088525-02
Award Id:
n/a
Agency Tracking Number:
R44DK088525
Solicitation Year:
2013
Solicitation Topic Code:
NIDDK
Solicitation Number:
PA12-088
Small Business Information
1281 Win Hentschel Blvd., WEST LAFAYETTE, IN, 47906-1075
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
826373792
Principal Investigator:
MARK CISNEROS
(765) 807-0778
mark.cisneros@nutrabiotix.com
Business Contact:
MARK CISNEROS
(765) 807-0778
mark.cisneros@nutrabiotix.com
Research Institute:
Stub




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.

* information listed above is at the time of submission.

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