Functional ConstipationPhase 4NCT01622972
Mode of Action of Moviprep
A Phase 4 study testing Polyethyleneglycol in people with Functional Constipation and Irritable Bowel Syndrome Characterized by Constipation, run by University of Nottingham at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Functional Constipation, Irritable Bowel Syndrome Characterized by Constipation
- What is being tested?
- Polyethyleneglycol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2011to Feb 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- Male or female who are 18-65 years
- BMI 18-30 kg/m2
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Nottingham Digestive Diseases Centre, University of Nottingham
Nottingham, NG7 2UH
About this study
Official title: Mode of Action of Moviprep:Impact on Distribution of Intestinal Fluid and Colonic Microbiota
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.
Read the detailed description
Routine examinations of the colon including colonoscopy and barium enema widely carried out in clinical practice require evacuation of colonic contents. This is most conveniently carried out using osmotic laxatives the most widely used preparation being based on polyethylene glycol such as Moviprep. When fully made up as 1 litre of Moviprep , it provides 100 grams of polyethlene glycol '3350' with a measured osmolarity of around 530 mosmol/l. Being nonnutrient, this would be expected to rapidly leave the stomach and generate a substantial inflow of fluid in the upper small intestine as water flows down the osmotic gradient markedly increasing the small intestinal water content compared with fasting.
Previous MRI studies using a Mannitol solution of 300 mosmols/l resulted in a small bowel secretion of fluid increasing total small bowel water to nearly 400 mls after a 300 ml meal. The investigators would anticipate a much larger increase after the hypertonic Moviprep. The flush of small bowel fluid induced by mannitol produces a radical change in the heterogeneous structure of the ascending colon as shown in our recent MRI images of the colon before and after mannitol.
Contrary to expectation colonic contents are far from homogenous with a spatially organised bacterial flora which others have described at a microscopic level which the investigators are just beginning to demonstrate using their novel MRI techniques. The colon should be regarded as a complex bioreactor which is spatially highly organised with a mucous layer overlying the enterocytes, the outer layer of mucus containing a germinal layer with bacteria which reseed the bioreactor when it is purged. The rate of recovery after purgation with polyethylene glycol is said to be normally rapid as the intact germinal layer rapidly recolonises but slower in certain patient groups though data is very limited as yet. The anecdotal yet persuasive patient accounts of improvement in bowel function after colonic lavage suggest that the reconstituted microbiota may be different, though this has yet to be studied using modern techniques.
Until recently the investigators have had no way of noninvasive imaging this complex structure but recent developments of high resolution MRI in Nottingham show that this is now feasible. Pilot data demonstrates that purging removes the heterogeneous three dimensional structure leaving homogeneous fluid contents with an intense proton signal. Just how this impacts on the colonic microbiota is as yet unknown as there have been no studies to date combining these novel approaches with new techniques now available for assessing the microbiota.
Early culture-based assessments identify only a minority of all the faecal organisms present and it is only in the last decade that methods based on assessment of microbial DNA have evolved to make it possible to describe the full complexity of the faecal microbiota. PCR of the highly conserved 16s ribosomal RNA gene shows the microbiota of individuals to be highly complex and individualised. Similarity indices show similarities of around two thirds over a 7 week period in healthy controls while those developing acute diarrhoea due to radiation enteritis show a marked reduction to just 26%. Similarly, HITChip analysis showed that subjects with IBS had an unstable microbiota that was stabilised following a probiotic intervention trial that improved the IBS symptom score. These techniques have yet to be applied to subjects undergoing bowel purgation. Moreover, there are novel approaches to identify the viability of the microbiota such as the use of specific probes that allow discrimination between intact, damaged and dead cells in fecal samples.
- Being tested
- Polyethyleneglycol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolyethyleneglycolDrug
Also called Macrogol 3350, Moviprep
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Healthy volunteers in Group 1: To give sachet's A and B made up to 1 litre with tap water once on day 1 and once on day 2 Receives: Drug: Polyethyleneglycol |
| Group 2 | Experimental | Healthy volunteers in group 2: To give 2x sachet's A and B made up to 2 litres with tap water on day 1. Receives: Drug: Polyethyleneglycol |
| Group 3 | Experimental | Patients with functional constipation and irritable bowel syndrome characterized by constipation: To give sachet's A and B made up to 1 litre with tap water once on day 1 Receives: Drug: Polyethyleneglycol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of 1 or 2 litre of Moviprep on area under curve (AUC) small bowel water content 0-6 hours on healthy volunteers
Healthy Volunteers
Measured: up to 24 hours
To assess area under curve of small bowel water content following 1litre of Moviprep on patients with constipation
Patients with constipation
Measured: up to 6 hours
Secondary outcomes (12)
Effect of 2 different dosing regimens of Moviprep on cleansing of the colon as assessed from colonic contents on the last scan at the end of purgation
Healthy volunteers
Measured: up to 24 hours
Effect of 2 different dosing regimens of Moviprep on the time course of the intestinal water content
Healthy volunteers
Measured: 6 weeks
Effect of 2 different dosing regimens of Moviprep on the time course of the ascending colon total chyme volume
healthy volunteers
Measured: 6 weeks
Effect of 2 different dosing regimens of Moviprep on the time course of the Colonic motility index 'cine' MRI movies
Healthy volunteers
Measured: 6 weeks
Effect of 2 different dosing regimens of Moviprep on the time course of the transit assessment from mean position of marker capsules
Healthy volunteers
Measured: 6 weeks
Comparison of single dose versus split dose on above MRI parameters
healthy volunteers
Measured: 6 weeks
Rate of recovery of normal colonic microbiota over days 2-28 assessed by bacterial DNA data (HITChip) and SCFA concentration
healthy volunteers
Measured: 6 weeks
Correlation between microbiota, SCFA and colonic MRI parameters
Healthy volunteers
Measured: 6 weeks
Ascending colon total chime volume
Patient with constipation
Measured: up to 6 hours
Colonic motility index 'cine; MRI movies
Patients with constipation
Measured: up to 6 hours
C) Comparison of the cross sectional area of the ascending colon with the cross sectional area of the transverse and descending colon
Patients with constipation
Measured: up to 6 hours
Transit assessment from mean position of marker capsules at 24 hours
Patients with constipation
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2012 (estimated)
- Study startSep 2011
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional ConstipationStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- Norgine
- Responsible party
- Sponsor
- Investigators
- Robin Spiller, MD FRCP, Study director, University of NottinghamChing Lam, MBChB MRCP, Principal investigator, University of NottinghamKlara Garsed, MBChB MRCP, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01622972
- Sponsor's protocol ID
- 10050
- Other IDs
- 2010-021879-85
- Status last verified
- Apr 2014
- First submitted
- 15 Jun 2012
- Last updated
- 14 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mode of Action of Moviprep:Impact on Distribution of Intestinal Fluid and Colonic Microbiota
- ClinicalTrials.gov ID
- NCT01622972
- Acronym / sponsor ID
- 10050
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- Norgine
- Study start
- Sep 2011
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 19 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Routine examinations of the colon including colonoscopy and barium enema widely carried out in clinical practice require evacuation of colonic contents. This is most conveniently carried out using osmotic laxatives the most widely used preparation being based on polyethylene glycol such as Moviprep. When fully made up as 1 litre of Moviprep , it provides 100 grams of polyethlene glycol '3350' with a measured osmolarity of around 530 mosmol/l. Being nonnutrient, this would be expected to rapidly leave the stomach and generate a substantial inflow of fluid in the upper small intestine as water flows down the osmotic gradient markedly increasing the small intestinal water content compared with fasting.
Previous MRI studies using a Mannitol solution of 300 mosmols/l resulted in a small bowel secretion of fluid increasing total small bowel water to nearly 400 mls after a 300 ml meal. The investigators would anticipate a much larger increase after the hypertonic Moviprep. The flush of small bowel fluid induced by mannitol produces a radical change in the heterogeneous structure of the ascending colon as shown in our recent MRI images of the colon before and after mannitol.
Contrary to expectation colonic contents are far from homogenous with a spatially organised bacterial flora which others have described at a microscopic level which the investigators are just beginning to demonstrate using their novel MRI techniques. The colon should be regarded as a complex bioreactor which is spatially highly organised with a mucous layer overlying the enterocytes, the outer layer of mucus containing a germinal layer with bacteria which reseed the bioreactor when it is purged. The rate of recovery after purgation with polyethylene glycol is said to be normally rapid as the intact germinal layer rapidly recolonises but slower in certain patient groups though data is very limited as yet. The anecdotal yet persuasive patient accounts of improvement in bowel function after colonic lavage suggest that the reconstituted microbiota may be different, though this has yet to be studied using modern techniques.
Until recently the investigators have had no way of noninvasive imaging this complex structure but recent developments of high resolution MRI in Nottingham show that this is now feasible. Pilot data demonstrates that purging removes the heterogeneous three dimensional structure leaving homogeneous fluid contents with an intense proton signal. Just how this impacts on the colonic microbiota is as yet unknown as there have been no studies to date combining these novel approaches with new techniques now available for assessing the microbiota.
Early culture-based assessments identify only a minority of all the faecal organisms present and it is only in the last decade that methods based on assessment of microbial DNA have evolved to make it possible to describe the full complexity of the faecal microbiota. PCR of the highly conserved 16s ribosomal RNA gene shows the microbiota of individuals to be highly complex and individualised. Similarity indices show similarities of around two thirds over a 7 week period in healthy controls while those developing acute diarrhoea due to radiation enteritis show a marked reduction to just 26%. Similarly, HITChip analysis showed that subjects with IBS had an unstable microbiota that was stabilised following a probiotic intervention trial that improved the IBS symptom score. These techniques have yet to be applied to subjects undergoing bowel purgation. Moreover, there are novel approaches to identify the viability of the microbiota such as the use of specific probes that allow discrimination between intact, damaged and dead cells in fecal samples.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: PolyethyleneglycolHealthy volunteers in Group 1: To give sachet's A and B made up to 1 litre with tap water once on day 1 and once on day 2 |
| Group 2 | Experimental | Drug: PolyethyleneglycolHealthy volunteers in group 2: To give 2x sachet's A and B made up to 2 litres with tap water on day 1. |
| Group 3 | Experimental | Drug: PolyethyleneglycolPatients with functional constipation and irritable bowel syndrome characterized by constipation: To give sachet's A and B made up to 1 litre with tap water once on day 1 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
- Male or female who are 18-65 years
Key exclusion criteria (19 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PolyethyleneglycolAlso: Macrogol 3350, MoviprepGroup 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. | Drug | Group 1, Group 2, Group 3 |
Primary outcome
Effect of 1 or 2 litre of Moviprep on area under curve (AUC) small bowel water content 0-6 hours on healthy volunteers
Time frame: up to 24 hours
Healthy Volunteers
To assess area under curve of small bowel water content following 1litre of Moviprep on patients with constipation
Time frame: up to 6 hours
Patients with constipation
12 secondary outcomes
Effect of 2 different dosing regimens of Moviprep on cleansing of the colon as assessed from colonic contents on the last scan at the end of purgation
Time frame: up to 24 hours
Effect of 2 different dosing regimens of Moviprep on the time course of the intestinal water content
Time frame: 6 weeks
Effect of 2 different dosing regimens of Moviprep on the time course of the ascending colon total chyme volume
Time frame: 6 weeks
Effect of 2 different dosing regimens of Moviprep on the time course of the Colonic motility index 'cine' MRI movies
Time frame: 6 weeks
Effect of 2 different dosing regimens of Moviprep on the time course of the transit assessment from mean position of marker capsules
Time frame: 6 weeks
Comparison of single dose versus split dose on above MRI parameters
Time frame: 6 weeks
Rate of recovery of normal colonic microbiota over days 2-28 assessed by bacterial DNA data (HITChip) and SCFA concentration
Time frame: 6 weeks
Correlation between microbiota, SCFA and colonic MRI parameters
Time frame: 6 weeks
Ascending colon total chime volume
Time frame: up to 6 hours
Colonic motility index 'cine; MRI movies
Time frame: up to 6 hours
C) Comparison of the cross sectional area of the ascending colon with the cross sectional area of the transverse and descending colon
Time frame: up to 6 hours
Transit assessment from mean position of marker capsules at 24 hours
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robin Spiller, MD FRCP study director
University of Nottingham
Ching Lam, MBChB MRCP principal investigator
University of Nottingham
Klara Garsed, MBChB MRCP principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Polyethyleneglycol in people with Functional Constipation and Irritable Bowel Syndrome Characterized by Constipation, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of 1 or 2 litre of Moviprep on area under curve (AUC) small bowel water content 0-6 hours on healthy volunteers (time frame: up to 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2014.