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Reclassifying Constipation Using Imaging and Manometry (RECLAIM)

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ClinicalTrials.gov Identifier: NCT03226145
Recruitment Status : Recruiting
First Posted : July 21, 2017
Last Update Posted : April 17, 2018
Sponsor:
Collaborators:
University College, London
Queen Mary University of London
Information provided by (Responsible Party):
University of Nottingham

Brief Summary:
Constipation is a common condition in which an individual suffers with hard stools which are infrequent and difficult to pass. It is poorly understood and treatment is often unsatisfactory. Many patients also experience pain whilst others do not but it is unclear why . It is believed that the pain arises from contractions in the colon, the lower part of the intestines. Some patients with constipation have weak colonic contraction but surprisingly some, particularly those with a lot of pain have strong contractions which are poorly coordinated. These patients all suffer from constipation but would are likely to need very different treatments. At present we cannot identify what type of abnormality of colonic contractions each individual patient suffers from and so are unable to give them the best treatment. This study will take advantage of two new techniques which have been recently developed. Magnetic Resonance Imaging (MRI) which will allow us to see the contractions of the colon in response to a dose of the laxative Moviprep which increases the flow of fluid into the proximal part of the colon and High Resolution Manometry (HRM) which measures the power and direction of the contraction in much more detail than ever before using a pressure sensing catheter placed into the bowel. Using these 2 techniques we will identify the pattern of contractions in 80 patients with constipation and 40 healthy controls. Participants will then enter into a controlled trial of either a drug which stimulates contractions or one which inhibits contraction. We anticipate that the pattern of contractions identified by the non-invasive MRI technique will predict which treatment will reduce their symptoms most as effectively as the more invasive HRM. If this is the case then our MRI test of colonic responsiveness could become widely used in routine clinical practice

Condition or disease Intervention/treatment Phase
Constipation - Functional Irritable Bowel Syndrome Characterized by Constipation Procedure: MRI Motility Procedure: High Resolution Manometry Drug: Bisacodyl Drug: Hyoscine butylbromide Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Reclassifying Constipation Using Magnetic Resonance Imaging Combined With High Resolution Manometry: A Validation Study And Double-Blind Crossover Trial
Actual Study Start Date : July 20, 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

Arm Intervention/treatment
Active Comparator: Patients

80 Patients : 40 FC 40 IBS-C

Will have MRI Motility and High Resolution Manometry

Then will have:

Bisacodyl 10mg once daily for 10 days, and matched placebo hyoscine butylbromide Buscopan 20mg three times daily for 10 days, and matched placebo

Both agents will have their matched placebo dispensed alongside the active product of the other agent.

All agents to be used in this study as tools for their known mechanisms of action, rather than to assess their effects.

Procedure: MRI Motility
MRI sequence to assess colonic motility

Procedure: High Resolution Manometry
HRM of colon to assess motility

Drug: Bisacodyl
Given as agent to monitor effect on symptoms and then to compare with motility data. Drug itself not being tested.

Drug: Hyoscine butylbromide
Given as agent to monitor effect on symptoms and then to compare with motility data. Drug itself not being tested.
Other Name: Buscopan

Active Comparator: Healthy Volunteers
40 HVs Will have MRI Motility and High Resolution Manometry No other interventions
Procedure: MRI Motility
MRI sequence to assess colonic motility

Procedure: High Resolution Manometry
HRM of colon to assess motility




Primary Outcome Measures :
  1. MRI Endpoint: Maximal MRI Motility Index (MMI) of the ascending colon (AC) [ Time Frame: During MRI scan (over 3 hours) ]
    MRI Measure of Colonic Motility

  2. HRM Endpoint: Percentage time occupied by cyclical propagating activity following meal [ Time Frame: During manometry recording (over 6 hours) ]
    Manometry recording of colonic motility

  3. Difference in average worst daily pain, scored on a range 1-5 between buscopan and bisacodyl intervention periods. [ Time Frame: Over 10 day period ]

Secondary Outcome Measures :
  1. Maximal MMI of the descending colon (DC) [ Time Frame: During MRI scan (over 3 hours) ]
  2. Whole Gut Transit [ Time Frame: Weighted Average Position Score of MRI transit markers 24 hours after ingestion ]
  3. Number of complete spontaneous bowel movements. [ Time Frame: 10 day period whilst on intervention (prucalopride/buscopan) ]
    CSBM is defined as a bowel movement occurring more than 24 hours after the most recent dose of rescue therapy, where the participant perceives complete evacuation of their rectum.

  4. Stool consistency [ Time Frame: 10 day period whilst on intervention (bisacodyl/buscopan) ]
    Defined as days per week of type 1& 2 on the Bristol Stool Form Scale (that has an integer range from 1-7)

  5. PAC-SYM Questionnaire Score [ Time Frame: Throughout study. Baseline then at end of each 10 day intervention period. ]
  6. Area Under the Curve for pressure 0-30 minute during HRM Number of High Amplitude Propagating Contractions (HAPCs) [ Time Frame: During manometry recording ( 6 hours) ]
  7. Number of High Amplitude Propagating Contractions (HAPCs) during HRM [ Time Frame: During manometry recording ( 6 hours) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Aged ≥ 16 years
  2. Capacity to give informed consent for participation
  3. Ability to understand written and spoken English
  4. For Constipation Group: Symptoms of constipation meeting Rome IV criteria for functional constipation or constipation-predominant irritable bowel syndrome
  5. For Control Group: No symptoms of constipation. This will be defined as a score of 5 or less on the Cleveland Clinic Score

Exclusion Criteria:

  • 1. Participation in any clinical trials in the past 3 months 2. Inability to understand written and spoken English 2.3. Pregnancy, assessed by a urinary pregnancy test, or current breastfeeding 3.4. History of significant adverse reaction or hypersensitivity, or known contra-indication to any of the medicinal products or equipment used in the study 4.5. History declared by the candidate of certain pre-existing gastrointestinal disorders, including:

    • inflammatory bowel disease
    • coeliac disease
    • cancer of the gastrointestinal tract 5.6. Any reported history of gastrointestinal resection (excluding appendicectomy or cholecystectomy) 6.7. Presence of an intestinal stoma 7.8. Causes of secondary constipation disorders (e.g. systemic sclerosis / Parkinson's disease) 9. Inability to cease use of medicines that cause constipation or alter colonic contractility (e.g. opioids, smooth muscle relaxants, tricyclic antidepressants) 8.10. Antibiotic use in the last 3 months 9.11. Comorbidity that would prevent safe adherence to the protocol (e.g. inability to lie flat, kidney disease contraindicating use of Moviprep or prucalopride) 10.12. Judgement by the PI that the candidate who will be unable to comply with the full study protocol (e.g. diabetes, severe COPD) 11.13. Contraindication to MRI or colonic manometry
    • Examples for MRI include claustrophobia, metallic implants, pacemakers, history of metallic foreign body in eye(s) and penetrating eye injury
    • Examples for manometry include diagnosis of previous complications of diverticular disease or previous endoscopic complications 12.14. Clinical evidence of significant pelvic organ prolapse syndromes 13.15. Inadequate screening diary following review iii. Control Group: A screening diary that records <6 complete spontaneous bowel motions in the fortnight.

iv. Constipation Group: A screening diary that records <2 or >6 complete spontaneous bowel motions in the fortnight


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03226145


Contacts
Contact: Robin Spiller 0115 951 5151 ext 31090 robin.spiller@nottingham.ac.uk
Contact: Victoria Wilkinson-Smith mszvw@exmail.nottingham.ac.uk

Locations
United Kingdom
University of Nottingham Recruiting
Nottingham, Notts, United Kingdom, NG7 2RD
Contact: Victoria Wilkinson-Smith    7870554040    mszvw@exmail.nottingham.ac.uk   
Principal Investigator: Robin Spiller         
Sub-Investigator: Giles Major         
Sub-Investigator: Victoria Wilkinson-Smith         
Sub-Investigator: Maura Corsetti         
Sub-Investigator: Luca Marciani         
Sub-Investigator: Caroline Hoad         
Sub-Investigator: Penny Gowland         
Queen Mary University of London Recruiting
London, United Kingdom
Contact: Mark Scott       m.scott@qmul.ac.uk   
Contact: Laura Brockway       l.brockway@qmul.ac.uk   
Principal Investigator: Mark Scott         
Sub-Investigator: Charles Knowles         
Sub-Investigator: Henriette Heinrich         
University College London Recruiting
London, United Kingdom
Contact: Stuart Taylor         
Contact: Laura Brockway       l.brockway@qmul.ac.uk   
Principal Investigator: Stuart Taylor         
Sub-Investigator: David Atkinson         
Sub-Investigator: Anton Emmanuel         
Sponsors and Collaborators
University of Nottingham
University College, London
Queen Mary University of London
Investigators
Principal Investigator: Robin Spiller University of Nottingham

Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT03226145     History of Changes
Other Study ID Numbers: 16105
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share IPD

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Colonic Diseases, Functional
Constipation
Irritable Bowel Syndrome
Signs and Symptoms, Digestive
Signs and Symptoms
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Bisacodyl
Scopolamine Hydrobromide
Butylscopolammonium Bromide
Cathartics
Gastrointestinal Agents
Laxatives
Adjuvants, Anesthesia
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Parasympatholytics