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,
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* 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 |
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