Status:
COMPLETED
Ispaghula and Colonic Water Content
Lead Sponsor:
University of Nottingham
Collaborating Sponsors:
Ironwood Pharmaceuticals, Inc.
Conditions:
Healthy
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Chronic constipation is a phenomenon which affects nearly 20% of the population worldwide. Bulking agents such as ispaghula are used as treatments, but only half of the patients are satisfied with the...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2016
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01805999
Start Date
March 1 2013
End Date
March 1 2016
Last Update
February 23 2017
Active Locations (1)
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1
NDD BRU and Sir Peter Mansfield Magnetic Resonance Centre
Nottingham, Nottinghamshire, United Kingdom, NG7 2RD