- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01805999
Ispaghula and Colonic Water Content
Effect of Ispaghula on Colonic Water Content
Study Overview
Status
Conditions
Detailed Description
The Rome III diagnostic criteria for constipation must include two or more of the following symptoms > 25 % of the time: straining, hard or lumpy stools, sense of incomplete evacuation, sensation of anorectal obstruction/blockage, the use of manual manoeuvres to facilitate defecation and fewer than 3 defecations per week. Treatments include osmotic laxatives such as polyethylene glycol and lactulose, stimulant laxatives such as bisacodyl, secretagogues like sodium docusate, and bulking agents such as psyllium.
A better understanding of the modes of action of these drugs is required, in order to provide better treatment for chronic constipation. This is somewhat challenging; partly because techniques available to study intestinal contents are limited, and some are unpleasant for the patients. The GI MRI group at the University of Nottingham has recently developed a non-invasive, patient friendly MRI technique for studying the colon. The technique allows assessment of colonic volumes, the response to meals, motility of the colon and transit time of ingested meals. This technique has been used to demonstrate the laxative effect of mannitol and its subsequent reversal with loperamide.
Using MRI, water provides a bright image on T2-weighted images in the small bowel, but the signal is rapidly lost once it reaches the colon. Pilot studies suggest that ispaghula; which is highly hygroscopic and can form a 1.5% gel with water, is able to maintain water in a form which produces bright images on T2-weighted scanning of the colon. The GI MRI group now want to confirm this pilot data by performing a placebo controlled trial of ispaghula husk in healthy volunteers, with the aim of further understanding the mode of action of bulking agents and further improve understanding of MRI parameters when applied to the colon. The aims will be achieved by performing a dose-finding mechanistic study in healthy volunteers, assessing their response to a test meal while taking either placebo, or 2 different doses of ispaghula. Stools will be collected, assessed for water content and compared to water content assessed from T2 weighted MRI. The studies will validate the current technique, optimise current MRI parameters and provide insights into the modes of action of ispaghula.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Nottinghamshire
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Nottingham, Nottinghamshire, United Kingdom, NG7 2RD
- NDD BRU and Sir Peter Mansfield Magnetic Resonance Centre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Apparently healthy; free from GI disorders, aged 18 and 65 years of age
- Male or female
- Body mass index (BMI) between 18.0 and 30.0 kg m-2
- Suitable for MRI scanning (eg absence of metal implants, infusion pumps and pacemakers as assessed by the MRI safety questionnaire
- No known gastrointestinal disease
- Not currently smoking
- No strenuous exercise greater than 10 hours per week
- No consumption of more than 21 units of alcohol in a typical week
- No reported participation in another nutritional or biomedical trial 3 months before the pre-study examination or during the study.
Exclusion Criteria:
- Inability to discontinue medication likely to alter GI transit
- Antibiotics in the 3 weeks before the pre-study examination
- Pre-existing condition making the need for antibiotics likely during the study
- Previous gastrointestinal surgery (excluding cholecystectomy and appendectomy)
- Known inflammatory bowel disease; coeliac disease
- Subjects considered by the investigator unlikely to comply with study protocol
- Regular (>3 times/week) use of Probiotics in the 3 weeks prior to, or during the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 7 g Ispaghula
Volunteer will take 7 g of ispaghula 3 times daily for one week
|
Other Names:
|
Placebo Comparator: 7 g placebo
Volunteer will take 7 g of a placebo 3 times a day for one week
|
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Active Comparator: 3.5g ispaghula + 3.5 g placebo
Volunteers will take 3.5 g of ispaghula with 3.5 g placebo 3 times daily for one week
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ascending colon free water content (ACWC)
Time Frame: 0 - 360 minutes
|
An assessment of the volume of water in the ascending colon, as obtained from MR images
|
0 - 360 minutes
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ascending, transverse and descending colon volumes
Time Frame: 0 - 360 minutes
|
The volumes of each region of the colon will be determined by segmenting MR images
|
0 - 360 minutes
|
Geometric centres (GC) 24 and 48 hours
Time Frame: t = 24 hours and t = 48 hours
|
The geometric centres of 5 transit marker pills will be determined at 24 and 48 hours after ingestion
|
t = 24 hours and t = 48 hours
|
Small bowel water content
Time Frame: 0 - 360 minutes
|
The volume of water in the small bowel will be evaluated from the MR images over the study day
|
0 - 360 minutes
|
Gastric emptying
Time Frame: 0 - 360 minutes
|
The rate of gastric emptying throughout the study day will be determined from MR images
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0 - 360 minutes
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Robin Spiller, MD, FRCP, University of Nottingham
- Study Director: Jeffrey Johnston, MD, FACP, Ironwood Pharmaceuticals, Inc.
- Principal Investigator: Luca Marciani, Laurea, PhD, University of Nottingham
- Principal Investigator: Kathryn Murray, PhD, University of Nottingham
- Principal Investigator: Giles Major, MB BChir, University of Nottiingham
- Principal Investigator: Ching Lam, MB BCh, University of Nottingham
- Principal Investigator: Caroline Hoad, PhD, University of Nottingham
- Principal Investigator: Penny Gowland, PhD, University of Nottingham
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H13122012SCS
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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