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

NCT02144753 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2016-05-02

No results posted yet for this study

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.

Conditions

  • Constipation-predominant IBS (IBS-C)

Interventions

DIETARY_SUPPLEMENT

NTX-1

Investigational NTX-1 fiber to be taken as three (6g each) packets of the fiber per day, one 8g packet in the morning (one hour before eating breakfast) and the other two 8g packets in the afternoon and evening.Fasting required for the morning dose and recommended with afternoon and evening dose.

DRUG

psyllium (15 g)

Psyllium (an over-the-counter fiber) to be taken as three (5g each) packets of the fiber per day, one 5g packet in the morning (one hour before eating breakfast) and the other two 5g packets in the afternoon and evening.Fasting required for the morning dose and recommended with afternoon and evening dose.

Sponsors & Collaborators

  • Rush University Medical Center

    collaborator OTHER

  • Nutrabiotix, LLC

    lead INDUSTRY

Principal Investigators

  • Ece Mutlu, MD · Rush University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2016-04-30
Completion
2016-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02144753 on ClinicalTrials.gov