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Mode of Action of Moviprep

NCT01622972 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2014-04-14

No results posted yet for this study

Summary

The University of Nottingham have been developing new, non-invasive magnetic resonance imaging (MRI) techniques to image the bowel. Building on those studies the investigators want to study, in healthy volunteers, the effects of purging on the colon. The investigators plan two studies using their novel MRI techniques in healthy volunteers to demonstrate how doses of a preparation designed to clean the bowel alters small and large bowel water content and transit. The investigators will also define the changes induced in colonic microbiota and how these are linked to changes in transit and the structure of colonic contents. This experimental model is comparable to an episode of acute diarrhea, therefore this study will also improve their understanding of the effects of diarrhea on bowel physiology.

Following from the above study, the investigators would like to extend this study on patients who have functional constipation and previously have not responded to conventional laxatives.

Conditions

  • Functional Constipation
  • Irritable Bowel Syndrome Characterized by Constipation

Interventions

DRUG

Polyethyleneglycol

Group 1 sachet's A and B made up to 1 litre with tap water once on day 1 and once on day 2. Group 2 2x sachet's A and B made up to 2 litres with tap water on day 1. Group 3 sachet's A and B made up to 1 litre with tap water once on day 1.

Sponsors & Collaborators

  • Norgine

    collaborator INDUSTRY

  • University of Nottingham

    lead OTHER

Principal Investigators

  • Robin Spiller, MD FRCP · University of Nottingham

  • Ching Lam, MBChB MRCP · University of Nottingham

  • Klara Garsed, MBChB MRCP · University of Nottingham

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2014-02-28
Completion
2014-02-28

Countries

  • United Kingdom

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 NCT01622972 on ClinicalTrials.gov