drugset / Trial / NCT02144753

Use of Novel Prebiotic Fiber for Targeted Dietary Management of Irritable Bowel Syndrome (Nutrabiotix Phase II)

NCT02144753

RandomizedParallel-groupQuadruple-blindSupportive care

Summary

The objective of this Phase II trial is to test the 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. The investigators 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 the US) for symptom improvement and is effective in correcting the abnormal colonic milieu in those with dysbiosis and low SCFA levels.

Timeline

Start
2014-03
Primary completion
2016-04
Completion
2016-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator PLANTAGO SEED Other / unclassified 15 g