Ispaghula and Colonic Water Content

Summary

Chronic constipation is a phenomenon which affects nearly 20% of the population worldwide. Bulking agents such as ispaghula are used as treatments, but only half of the patients are satisfied with the treatment. This highlights a need for better treatment options, which requires a deeper understanding of the gastrointestinal fate of the products. The GI MRI Research group at the University of Nottingham has been developing new, non-invasive magnetic resonance imaging (MRI) techniques to image the gastrointestinal tract. In collaboration with Ironwood Pharmaceuticals, the investigators now want to understand the gastrointestinal fate of an ispaghula treatment, and also to improve the understanding of MRI parameters when they are applied to the colon.

Conditions

• Healthy

Interventions

DIETARY_SUPPLEMENT

7 g Ispaghula

DIETARY_SUPPLEMENT

7 g placebo

DIETARY_SUPPLEMENT

3.5g Ispaghula + 3.5 g placebo

Sponsors & Collaborators

• Ironwood Pharmaceuticals, Inc.

  collaborator INDUSTRY

• University of Nottingham

  lead OTHER

Principal Investigators

• Robin Spiller, MD, FRCP · University of Nottingham

• Jeffrey Johnston, MD, FACP · Ironwood Pharmaceuticals, Inc.

• Luca Marciani, Laurea, PhD · University of Nottingham

• Kathryn Murray, PhD · University of Nottingham

• Giles Major, MB BChir · University of Nottiingham

• Ching Lam, MB BCh · University of Nottingham

• Caroline Hoad, PhD · University of Nottingham

• Penny Gowland, PhD · University of Nottingham

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2013-03-31

Primary Completion

2013-10-31

Completion

2016-03-31

Countries

• United Kingdom

Study Locations