Multiple Sclerosis Clinical Trial
Official title:
Characteristics of INTESTINAL DYSFUNCTION in Patients With MULTIPLE SCLEROSIS. Effectiveness of the TRANSANAL IRRIGATION PROCEDURE With the PERISTEEN DEVICE in the Treatment of Constipation and Disease-related Anal Incontinence
NCT number | NCT04599595 |
Other study ID # | 170485 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 7, 2018 |
Est. completion date | April 10, 2020 |
Verified date | October 2020 |
Source | University Hospital of Ferrara |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
MS (Multiple Sclerosis) is the most common neurological disease involving disabilities in young adults, with bowel symptoms, in particular constipation and fecal incontinence. The main objectives of the study are to assess the prevalence, characteristics, severity and impact on the Quality of Life of intestinal disorders in this population, to correlate the severity and characteristics of constipation and fecal incontinence with Intestinal Transit Time and the time dedicated to the evacuation, and how these items change in relation to the use of transanal irrigation (TAI). Another objective is to identify the composition of the intestinal microbiota in MS patients in relation to the type of bowel characteristics, comparing it with microbiota profile of the healthy population of the same region of origin, Emilia-Romagna, Italy.
Status | Completed |
Enrollment | 100 |
Est. completion date | April 10, 2020 |
Est. primary completion date | April 10, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients =18 years of age, both sexes - Diagnosis of MS for no more than 10 years - Residence in the Italian Region of Emilia Romagna, Italy Exclusion Criteria: - EDSS (Expanded Disability Status Scale) < or =7 - Diagnosis of Celiac Disease, Inflammatory Bowel Disease (Ulcerative Colitis or Crohn's Disease) - Evidence of Diverticular Colon Disease - Previous or ongoing neoplastic diseases of the digestive system - Endocrine disorders such as uncompensated hypothyroidism, diabetes mellitus in treatment, hypoparathyroidism, pheochromocytoma - Other neurological disorders such as M. of Parkinson's, S. of Shy Drager. - Taking drugs that affect intestinal transit (opiates, antiepileptic drugs, major antidepressants, calcium antagonists, anticholinergics, antidopaminergics) - Evidence of rectal or occult bleeding in the last 3 months - Infectious episodes in progress (*) NOTES: (*) Rational: it is not considered ethical or functional to carry out such research in patients with infectious organ diseases requiring antibiotic and/or inflammatory therapies. |
Country | Name | City | State |
---|---|---|---|
Italy | Simona Ascanelli | Ferrara |
Lead Sponsor | Collaborator |
---|---|
University Hospital of Ferrara |
Italy,
Abrahamsson H, Antov S. Accuracy in assessment of colonic transit time with particles: how many markers should be used? Neurogastroenterol Motil. 2010 Nov;22(11):1164-9. doi: 10.1111/j.1365-2982.2010.01543.x. — View Citation
Agachan F, Chen T, Pfeifer J, Reissman P, Wexner SD. A constipation scoring system to simplify evaluation and management of constipated patients. Dis Colon Rectum. 1996 Jun;39(6):681-5. — View Citation
Altomare DF, Spazzafumo L, Rinaldi M, Dodi G, Ghiselli R, Piloni V. Set-up and statistical validation of a new scoring system for obstructed defaecation syndrome. Colorectal Dis. 2008 Jan;10(1):84-8. Epub 2007 Apr 18. — View Citation
Bazzocchi G., Poletti E., Avogadri A. L'irrigazione retrograda transanale per il bowel management del paziente con lesione midollare mediante dispositivi a pressione costante, razionale e procedura per l'utilizzo del Peristeen. Pelviperineology 2012; 31:
Bharucha AE, Wald A, Enck P, Rao S. Functional anorectal disorders. Gastroenterology. 2006 Apr;130(5):1510-8. Review. — View Citation
Bouchoucha M, Devroede G, Arhan P, Strom B, Weber J, Cugnenc PH, Denis P, Barbier JP. What is the meaning of colorectal transit time measurement? Dis Colon Rectum. 1992 Aug;35(8):773-82. — View Citation
Cadeddu F, Salis F, De Luca E, Ciangola I, Milito G. Efficacy of biofeedback plus transanal stimulation in the management of pelvic floor dyssynergia: a randomized trial. Tech Coloproctol. 2015 Jun;19(6):333-8. doi: 10.1007/s10151-015-1292-7. Epub 2015 Ma — View Citation
Chia YW, Fowler CJ, Kamm MA, Henry MM, Lemieux MC, Swash M. Prevalence of bowel dysfunction in patients with multiple sclerosis and bladder dysfunction. J Neurol. 1995 Jan;242(2):105-8. — View Citation
Christensen P, Bazzocchi G, Coggrave M, Abel R, Hultling C, Krogh K, Media S, Laurberg S. A randomized, controlled trial of transanal irrigation versus conservative bowel management in spinal cord-injured patients. Gastroenterology. 2006 Sep;131(3):738-47 — View Citation
Christensen P, Krogh K. Transanal irrigation for disordered defecation: a systematic review. Scand J Gastroenterol. 2010 May;45(5):517-27. doi: 10.3109/00365520903583855. Review. — View Citation
Del Popolo G, Mosiello G, Pilati C, Lamartina M, Battaglino F, Buffa P, Redaelli T, Lamberti G, Menarini M, Di Benedetto P, De Gennaro M. Treatment of neurogenic bowel dysfunction using transanal irrigation: a multicenter Italian study. Spinal Cord. 2008 — View Citation
Emmanuel AV, Krogh K, Bazzocchi G, Leroi AM, Bremers A, Leder D, van Kuppevelt D, Mosiello G, Vogel M, Perrouin-Verbe B, Coggrave M, Christensen P; Members of working group on Trans Anal Irrigation from UK, Denmark, Italy, Germany, France and Netherlands. — View Citation
Hornby A. The MS sufferer in the community. Nurs Times. 1978 May 11;74(19):suppl 130-1. — View Citation
Jorge JM, Wexner SD. Etiology and management of fecal incontinence. Dis Colon Rectum. 1993 Jan;36(1):77-97. Review. — View Citation
Koutsouraki E, Costa V, Baloyannis S. Epidemiology of multiple sclerosis in Europe: a review. Int Rev Psychiatry. 2010;22(1):2-13. doi: 10.3109/09540261003589216. Review. — View Citation
Krogh K, Christensen P, Sabroe S, Laurberg S. Neurogenic bowel dysfunction score. Spinal Cord. 2006 Oct;44(10):625-31. Epub 2005 Dec 13. — View Citation
Marquis P, De La Loge C, Dubois D, McDermott A, Chassany O. Development and validation of the Patient Assessment of Constipation Quality of Life questionnaire. Scand J Gastroenterol. 2005 May;40(5):540-51. — View Citation
Neri L, Basilisco G, Corazziari E, Stanghellini V, Bassotti G, Bellini M, Perelli I, Cuomo R; LIRS Study Group. Constipation severity is associated with productivity losses and healthcare utilization in patients with chronic constipation. United European — View Citation
Nordenbo AM, Andersen JR, Andersen JT. Disturbances of ano-rectal function in multiple sclerosis. J Neurol. 1996 Jun;243(6):445-51. — View Citation
Norton C, Chelvanayagam S. Bowel problems and coping strategies in people with multiple sclerosis. Br J Nurs. 2010 Feb 25-Mar 10;19(4):220, 221-6. — View Citation
Nortvedt MW, Riise T, Frugård J, Mohn J, Bakke A, Skår AB, Nyland H, Glad SB, Myhr KM. Prevalence of bladder, bowel and sexual problems among multiple sclerosis patients two to five years after diagnosis. Mult Scler. 2007 Jan;13(1):106-12. — View Citation
Preziosi G, Raptis DA, Storrie J, Raeburn A, Fowler CJ, Emmanuel A. Bowel biofeedback treatment in patients with multiple sclerosis and bowel symptoms. Dis Colon Rectum. 2011 Sep;54(9):1114-21. doi: 10.1097/DCR.0b013e318223fd7b. — View Citation
Wiesel PH, Norton C, Glickman S, Kamm MA. Pathophysiology and management of bowel dysfunction in multiple sclerosis. Eur J Gastroenterol Hepatol. 2001 Apr;13(4):441-8. Review. — View Citation
Wiesel PH, Norton C, Roy AJ, Storrie JB, Bowers J, Kamm MA. Gut focused behavioural treatment (biofeedback) for constipation and faecal incontinence in multiple sclerosis. J Neurol Neurosurg Psychiatry. 2000 Aug;69(2):240-3. — View Citation
Yiannakou Y, Piessevaux H, Bouchoucha M, Schiefke I, Filip R, Gabalec L, Dina I, Stephenson D, Kerstens R, Etherson K, Levine A. A randomized, double-blind, placebo-controlled, phase 3 trial to evaluate the efficacy, safety, and tolerability of prucalopri — View Citation
* Note: There are 25 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence and prevalence of intestinal dysfunction in Multiple sclerosis | Incidence and prevalence of intestinal dysfunction in Multiple Sclerosis by calculation of percentage of patients with a PACQoL score = 32 for items B.1 to B.6 and/or a score = 11 for item B.7 of the questionnaire. | 2 years | |
Primary | Intestinal transit time in SM patients with intestinal dysfunction | Calculation of percentage of patients with a slowed Intestinal Transit Time (= 60 hours for females and 55 hours for men) | 2 years | |
Secondary | Analysis of Microbiota in MS patients with intestinal dysfunction, before and after treatment with TAI. | Compare the composition of the intestinal microbiota of MS patients with the known "healthy" profile of the Italian population of North East of Italy and assess any changes after the period of treatment with TAI. | 2 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05528666 -
Risk Perception in Multiple Sclerosis
|
||
Completed |
NCT03608527 -
Adaptive Plasticity Following Rehabilitation in Multiple Sclerosis
|
N/A | |
Recruiting |
NCT05532943 -
Evaluate the Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cells in Patients With Multiple Sclerosis
|
Phase 1/Phase 2 | |
Completed |
NCT02486640 -
Evaluation of Potential Predictors of Adherence by Investigating a Representative Cohort of Multiple Sclerosis (MS) Patients in Germany Treated With Betaferon
|
||
Completed |
NCT01324232 -
Safety and Efficacy of AVP-923 in the Treatment of Central Neuropathic Pain in Multiple Sclerosis
|
Phase 2 | |
Completed |
NCT04546698 -
5-HT7 Receptor Implication in Inflammatory Mechanisms in Multiple Sclerosis
|
||
Active, not recruiting |
NCT04380220 -
Coagulation/Complement Activation and Cerebral Hypoperfusion in Relapsing-remitting Multiple Sclerosis
|
||
Completed |
NCT02835677 -
Integrating Caregiver Support Into MS Care
|
N/A | |
Completed |
NCT03686826 -
Feasibility and Reliability of Multimodal Evoked Potentials
|
||
Recruiting |
NCT05964829 -
Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis
|
N/A | |
Withdrawn |
NCT06021561 -
Orofacial Pain in Multiple Sclerosis
|
||
Completed |
NCT03653585 -
Cortical Lesions in Patients With Multiple Sclerosis
|
||
Recruiting |
NCT04798651 -
Pathogenicity of B and CD4 T Cell Subsets in Multiple Sclerosis
|
N/A | |
Active, not recruiting |
NCT05054140 -
Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients With Progressive Multiple Sclerosis
|
Phase 2 | |
Completed |
NCT05447143 -
Effect of Home Exercise Program on Various Parameters in Patients With Multiple Sclerosis
|
N/A | |
Recruiting |
NCT06195644 -
Effect of Galvanic Vestibular Stimulation on Cortical Excitability and Hand Dexterity in Multiple Sclerosis Patients
|
Phase 1 | |
Completed |
NCT04147052 -
iSLEEPms: An Internet-Delivered Intervention for Sleep Disturbance in Multiple Sclerosis
|
N/A | |
Completed |
NCT03594357 -
Cognitive Functions in Patients With Multiple Sclerosis
|
||
Completed |
NCT03591809 -
Combined Exercise Training in Patients With Multiple Sclerosis
|
N/A | |
Completed |
NCT02845635 -
MS Mosaic: A Longitudinal Research Study on Multiple Sclerosis
|