Mode of Action of Moviprep

• Status: Completed
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Nottingham
• Collaborator: Norgine
• Treatments: Polyethylene glycol 3350

Criteria

Inclusion Criteria Group 1 and 2:

• Male or female healthy volunteers who are 18-65 years

• BMI 18-28 kg/m2

• Able to give voluntary written informed consent to participate in the study

• Able to understand the requirements of the study, including anonymous publication, and agree to co-operate with the study procedures

Inclusion Criteria Group 3:

• Male or female who are 18-65 years

• BMI 18-30 kg/m2

• Able to give voluntary written informed consent to participate in the study

• Able to understand the requirements of the study, including anonymous publication, and agree to co-operate with the study procedures

• Patient diagnosed with constipation predominant irritable bowel syndrome who failed to respond to at least 1 laxative treatment in the past

• Patient diagnosed with functional constipation who failed to respond to 1-2 sachets of Movicol per day

Exclusion Criteria for group 1 and 2:

• Any history of serious acute or chronic illness especially gastrointestinal

• Diabetes Mellitus

• Pregnancy or breast feeding

• Smoking

• Unsuitable for MRI scanning (i.e. have metal implants or a pace maker)

• Regular use of medication interfering with gastrointestinal function including opiates or constipating drugs

• Subjects using the oral contraceptive pill will be excluded if not prepared to use an alternative barrier method of contraception for the duration of the menstrual cycle following dosing with Moviprep

• Substance abuse

• Have taken part in another clinical study within the previous 3 months

• Previous gastrointestinal surgery of any kind apart from appendicectomy

Exclusion criteria for group 3:

• Any history of serious acute or chronic illness especially gastrointestinal

• Diabetes Mellitus

• Pregnancy or breast feeding

• Unsuitable for MRI scanning (i.e. have metal implants or a pace maker)

• Regular use of medication interfering with gastrointestinal function including opiates or constipating drugs

• Subjects using the oral contraceptive pill will be excluded if not prepared to use an alternative barrier method of contraception for the duration of the menstrual cycle following dosing with Moviprep

• Substance abuse

• Have taken part in another clinical study within the previous 3 months

• Previous gastrointestinal surgery of any kind apart from appendicectomy/cholecystectomy