Overview

This trial is active, not recruiting.

Condition constipation
Treatments ispaghula, maltodextrin
Sponsor University of Nottingham
Collaborator Ironwood Pharmaceuticals, Inc.
Start date March 2014
End date February 2015
Trial size 24 participants
Trial identifier NCT02144376, 14GA006, UON14011

Summary

The purpose of the study is to test how well magnetic resonance imaging (MRI) can measure whole gut transit time in people with constipation, and how readily it can detect a change in transit time induced by taking a dietary supplement with laxative effects.The investigators expect to demonstrate that ispaghula (psyllium) accelerates movement of matter through the intestinal tract.

The investigators will also assess whether a change in gut bacteria and the chemicals that they release can be detected.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose basic science
Arm
(Placebo Comparator)
7 days without use of laxatives other than standardised rescue therapy 7 grams maltodextrin taken 3 times daily, at least 4 hours apart, for up to 7 days
maltodextrin
(Active Comparator)
7 days without use of laxatives other than standardised rescue therapy 7 grams ispaghula/ psyllium taken 3 times daily, at least 4 hours apart, for up to 7 days
ispaghula psyllium

Primary Outcomes

Measure
Weighted Average Position Score of transit marker capsules as determined by MRI
time frame: 24 hours after ingestion

Secondary Outcomes

Measure
Weighted Average Position Score of 5 transit marker capsules, as determined by MRI
time frame: 48 hours after ingestion
Small Bowel Water Content (SBWC) in millilitres(mL) measured by MRI
time frame: -60, 0, 60, 120, 180, 240, 300, 360, 420 minutes after test meal
Small Bowel Water Content (SBWC) in millilitres measured by MRI
time frame: Baseline, 60 minutes before test meal
Ascending Colon Water Content in millilitres measured by MRI
time frame: Baseline, 60 minutes before test meal
Ascending Colon Water Content in millilitres measured by MRI
time frame: -60, 0, 60, 120, 180, 240, 300, 360, 420 minutes after test meal
Change from baseline in Ascending Colon Water Content in millilitre measured by MRI
time frame: test meal -60, test meal +60
Change from before to after challenge meal in Ascending Colon Water Content before in millilitre measured by MRI
time frame: test meal +360 minutes, test meal + 420 minutes
Ascending Colon T1
time frame: -60, 0, 60, 120, 180, 240, 300, 360, 420 minutes after test meal
Descending Colon T1
time frame: -60, 0, 60, 120, 180, 240, 300, 360, 420 minutes after test meal
Ascending colon T2
time frame: -60, 0, 60, 120, 180, 240, 300, 360, 420 minutes after test meal
Descending Colon T2
time frame: -60, 0, 60, 120, 180, 240, 300, 360, 420 minutes after test meal

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Meets Rome III Criteria for diagnosis of Functional Constipation5 on questionnaire (NB. Both those who do and do not meet IBS criteria will be eligible) - At least one bowel motion per week while taking usual laxatives - Able to give informed consent - Aged 18 or older Exclusion Criteria: - History declared by the candidate of other pre-existing gastrointestinal disorder, including but not limited to: - Inflammatory Bowel Disease - Coeliac Disease diagnosed in the last year - Pancreatitis - Cancer of the gastrointestinal tract - Any reported history of gastrointestinal resection (excluding appendicectomy or cholecystectomy) - Presence of an intestinal stoma - Pregnancy declared by candidate (no formal testing) - Contraindications for MRI scanning i.e. metallic implants, pacemakers, history of metallic foreign body in eye(s) and penetrating eye injury - Reported alcohol intake of >28 units/ week with daily drinking - Any use of a product containing ispaghula or psyllium in the 4 weeks prior to consent - Unable to avoid use of dihydrocodeine or morphine during the study - If taking other regular opiates such as codeine, fentanyl or Oxycodone, participants should be able to maintain a stable dose throughout the study - Any reported history of hypersensitivity or significant adverse reaction to ispaghula, maltodextrin or bisacodyl - Unable to stop drugs and other agents used primarily for their laxative effect, during periods of screening, washout, baseline and treatment (maximum 15 days - rescue medication will be provided). - Antibiotic or prescribed probiotic treatment in the past 4 weeks - Inability to lie flat or exceed scanner limits of weight <120kg - Poor understanding of English language - Participation in any medical trials for the past 3 months - Any condition where the candidate is likely to require a course of antibiotics in the next 3 months e.g. severe chronic respiratory disease, recurrent urinary tract infection, lower limb ulceration - Judgement by the PI that the candidate who will be unable to comply with the full study protocol e.g. Diabetes, severe COPD During the screening 2 weeks off laxatives - No bowel motions recorded during screening period - ≥3 complete spontaneous bowel motions (CSBMs - bowel motion with the feeling of complete evacuation, without the use of rescue therapy in the preceding 24 hours) per week

Additional Information

Official title Validation of Magnetic Resonance Imaging to Characterise Gastrointestinal Physiology, Gut Luminal Content and Its Interaction With Colonic Microbiota in Patients With Chronic Constipation
Principal investigator Giles Major, BM BCh MRCP
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of Nottingham.