Reclassifying Constipation Using Imaging and Manometry

• Status: Unknown status
• Trial end date: 2021-06-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Nottingham
• Collaborators: Queen Mary University of London; University College, London
• Treatments: Bisacodyl; Butylscopolammonium Bromide; Scopolamine; Scopolamine Hydrobromide

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