MRI and Microbiota Analysis in Constipation
- Conditions
- Constipation
- Interventions
- Dietary Supplement: MaltodextrinDietary Supplement: Ispaghula
- Registration Number
- NCT02144376
- Lead Sponsor
- University of Nottingham
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Maltodextrin Maltodextrin 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 Ispaghula Ispaghula 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
- Primary Outcome Measures
Name Time Method Weighted Average Position Score of transit marker capsules as determined by MRI 24 hours after ingestion After 4 days of study product participants will ingest 5 transit mark capsules, the use of which has been shown to measure whole gut transit in a similar manner to more established techniques. They will continue to take study product before undergoing an MRI scan to assess capsule position
- Secondary Outcome Measures
Name Time Method Weighted Average Position Score of 5 transit marker capsules, as determined by MRI 48 hours after ingestion After 4 days of study product participants will ingest 5 transit mark capsules, the use of which has been shown to measure whole gut transit in a similar manner to more established techniques. They will continue to take study product before undergoing an MRI scan to assess capsule position
Small Bowel Water Content (SBWC) in millilitres(mL) measured by MRI -60, 0, 60, 120, 180, 240, 300, 360, 420 minutes after test meal Area under the curve (mL.min) will be calculated from hourly MRI scans
Small Bowel Water Content (SBWC) in millilitres measured by MRI Baseline, 60 minutes before test meal After 5 days of taking the study product participants will undergo an MRI scan while fasted.
Ascending Colon Water Content in millilitres measured by MRI -60, 0, 60, 120, 180, 240, 300, 360, 420 minutes after test meal Area under the curve (mL.min) will be calculated from hourly MRI scans
Change from baseline in Ascending Colon Water Content in millilitre measured by MRI test meal -60, test meal +60 Difference between measurement Meal -60 (fasting) and Meal +60
Change from before to after challenge meal in Ascending Colon Water Content before in millilitre measured by MRI test meal +360 minutes, test meal + 420 minutes Difference between time points Meal2 -20 and Meal 2 +40
Ascending Colon T1 -60, 0, 60, 120, 180, 240, 300, 360, 420 minutes after test meal Area under the curve of MRI parameter measured at hourly time points
Descending Colon T1 -60, 0, 60, 120, 180, 240, 300, 360, 420 minutes after test meal Area under the curve of MRI parameter measured at hourly time points
Ascending colon T2 -60, 0, 60, 120, 180, 240, 300, 360, 420 minutes after test meal Area under the curve of MRI parameter measured at hourly time points
Descending Colon T2 -60, 0, 60, 120, 180, 240, 300, 360, 420 minutes after test meal Area under the curve of MRI parameter measured at hourly time points
Trial Locations
- Locations (2)
Nottingham University Hospitals NHS Trust
🇬🇧Nottingham, United Kingdom
University of Nottingham
🇬🇧Nottingham, United Kingdom