Mode of action of Moviprep:impact on distribution of intestinal fluid and colonic microbiota - Mode of Action of Moviprep version 1.0

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-021879-85-GB

Enrollment

Registered

2010-08-27

Start date

2010-09-08

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

for bowel cleansing prior to any clinical procedure requiring a clean bowel, e.g, bowel endoscopy, lower gastrointestinal tract radiology or digestive tract surgery.

Interventions

Trade Name: Moviprep Product Name: Moviprep Pharmaceutical Form: Powder for oral solution INN or Proposed INN: Sodium Sulphate CAS Numbe

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Any history of serious acute or chronic illness especially gastrointestinal Diabetes Mellitus Pregnancy or breastfeeding Smoking Unsuitable for MRI scanning (i.e. have metal implants or pacemaker) Anyone taking regular medication interfering with gastrointestinal function including opiates or constipating drugs. Subjects using the combined oral contraceptive pill or progesterone only pill will be excluded if not prepared to use an alternative barrier method for the duration of the menstrual cycle following dosing with moviprep. Substance abuse Have taken part in any other clinical study within the previous 3 months Previous gastrointestinal surgery of any kind (excluding appendicectomy)

Design outcomes

Primary

Measure	Time frame
Main Objective: Patients often have to take osmotic laxatives to prepare the colon for colonoscopy or barium enema. We are interested in how these work and whether taking the dose all at once or in divided doses will affect the water distribution in the small bowel. ;Secondary Objective: We are also interested in how this bowel cleansing alters the gut bacteria and gut function since this may be relevant to many patients with irritable bowel syndrome (IBS) who have disturbed bowel habit and altered gut bacteria. This study will use a laxative model of an episode of diarrhoea and we will use magnetic resonance imaging (MRI) to take images of the small bowel and the colon at intervals. We will also measure the bacteria present in the stools. ;Primary end point(s): Primary Endpoint: Effect of 1 & 2 litres of Moviprep on AUC small bowel water content 0-6 hours	—

Measure

Time frame

Main Objective: Patients often have to take osmotic laxatives to prepare the colon for colonoscopy or barium enema. We are interested in how these work and whether taking the dose all at once or in divided doses will affect the water distribution in the small bowel. ;Secondary Objective: We are also interested in how this bowel cleansing alters the gut bacteria and gut function since this may be relevant to many patients with irritable bowel syndrome (IBS) who have disturbed bowel habit and altered gut bacteria. This study will use a laxative model of an episode of diarrhoea and we will use magnetic resonance imaging (MRI) to take images of the small bowel and the colon at intervals. We will also measure the bacteria present in the stools. ;Primary end point(s): Primary Endpoint: Effect of 1 & 2 litres of Moviprep on AUC small bowel water content 0-6 hours

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026