SBIR-STTR Award

To establish the proof of concept that Nutrabiotix fiber is safe and well tolerated, promotes gut health by increasing production of short chain fatty acids and changes colonic microbiota composition in favor of bifidobacteria, improves bowel habit and increase in stool weight. To this end, we will conduct a randomized, double blind, controlled, dose ranging, 3 arm trial in 120 healthy subjects comparing two doses of the Nutrabiotix fiber to psyllium fiber.

Public Health Relevance:
The completion of this project will prove the efficacy and tolerability of Nutrabiotix fiber in humans and will form the basis of commercializing a well tolerated natural carbohydrate product with targeted delivery to the colon that promotes "gut health" and potentially, prevents and treats colonic diseases where changes in the gut microbiota and/or colonic milieu play a key pathogenic role.

Thesaurus Terms:
Active Follow-Up; Adverse Effects; Affect; Alginates; Arm; Bacteria; Bifidobacterium; Butyrates; Carbohydrates; Carbol; Carbolic Acid; Characteristics; Clostridium; Colitis, Mucous; Colon; Colon Cancer; Colon Carcinoma; Colon, Irritable; Colonic Carcinoma; Colonic Diseases; Constipation; Data; Defecation; Diet; Disease; Disorder; Distal; Diverticulitis; Dose; Double-Blind Method; Double-Blind Study; Double-Blinded; Double-Masked Method; Double-Masked Study; Dysfunction; Enrollment; Fatty Acids, Short-Chain; Fatty Acids, Volatile; Feces; Fermentation; Fiber; Functional Disorder; Gambling; Gamblings; Gastrointestinal Tract, Feces; Gastrointestinal Tract, Small Intestine; Goals; Habits; Health; Hour; Human; Human, General; Hydroxybenzene; In Vitro; Indoles; Inflammatory; Inflammatory Bowel Diseases; Inflammatory Bowel Disorder; Inflammatory Intestinal Disease; Inflammatory Intestinal Disorder; Intestinal; Intestinal Diseases; Intestinal Disorder; Intestines; Intestines, Small; Irritable Bowel Syndrome; Man (Taxonomy); Man, Modern; Metabolic Syndrome; Metamucil; Microbeads; Microspheres; Names; Non-Starch Polysaccharide; Obesity; Patient Self-Report; Phase; Phenols; Physiopathology; Play; Population; Procedures; Process; Production; Property; Property, Loinc Axis 2; Proteins; Psyllium; Psyllium Gum; Randomized; Role; Running; Sbir; Sbirs (R43/44); Self-Report; Sepsis; Series; Small Business Innovation Research; Small Business Innovation Research Grant; Small Intestines; Starch; Systemic Disease; Testing; Trademark; Treatment Side Effects; Upper Arm; Volatile Fatty Acids; Weight; Adiposity; Base; Bloodstream Infection; Bowel; Bowel Movement; Colon Disorder; Common Treatment; Corpulence; Corpulency; Corpulentia; Disease/Disorder; Enroll; Follow-Up; Gene Product; Gut Microbiota; Improved; Intestine Disorder; Nonalcoholic Steatohepatitis; Obese; Obese People; Obese Person; Obese Population; Pathophysiology; Phase 2 Study; Prebiotics; Prevent; Preventing; Primary Outcome; Public Health Relevance; Randomisation; Randomization; Randomly Assigned; Secondary Outcome; Side Effect; Site Targeted Delivery; Small Bowel; Social Role; Spastic Colon; Stool; Targeted Delivery; Therapy Adverse Effect; Treatment Adverse Effect

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 Statement:


Public Health Relevance:
The completion of this project will prove the efficacy and tolerability of Nutrabiotix Fiber in humans as a medical food for 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.

Project Terms:
Abdominal Pain; Address; Adverse effects; Affect; Antibiotics; arm; base; Beryllium; branched chain fatty acid; Butyrates; Carbohydrates; Characteristics; Clinical; Colitis; Colon; Constipation; Development; Diet; Disease; Diverticulosis; Dose; Double-Blind Method; Dropout; effective therapy; Effectiveness; Feces; Fermentation; Fiber; follow-up; Food Supplements; Frequencies (time pattern); Funding; Gases; Generations; Goals; gut microbiota; Habits; Health; Human; Immune; improved; Indoles; Inflammation; Inflammatory; Intestines; Irritable Bowel Syndrome; Lead; Manufacturer Name; medical food; Metabolic syndrome; Microspheres; Neuraxis; novel; Nutritional; Outcome; Pathogenesis; patient population; Patients; Phase; phase 1 study; phase 2 study; Phase II Clinical Trials; Phenols; Physicians; Play; prebiotics; Primary Health Care; primary outcome; Probiotics; Property; Proteins; Psyllium; public health relevance; Randomized; Reporting; response; Role; Rome; Running; Series; Severities; Small Business Innovation Research Grant; Starch; Supervision; Symptoms; Systemic disease; targeted delivery; Testing; Visceral; Volatile Fatty Acids