Characteristics of INTESTINAL DYSFUNCTION in Patients With MULTIPLE SCLEROSIS

NCT04599595 | Completed DMC

• 1 other identifier: 170485
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis; Intestinal Dysfunction; Anal Incontinence; Microbiota

Keywords

transanal irrigation

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Analysis of Microbiota in MS patients with intestinal dysfunction, before and after treatment with TAI.

  2 years

Study Arms (1)

Multiple Scerosis (MS) Group

This group will be composed by 150 MS patients who, consecutively, from the start of the study, will refer to the MS clinic of the Neurology Unit of the Ferrara University Hospital, Italy. The first 50 patients with a PACQoL score ≥ 32 will be asked to be willing to enter the next phase of the study that continues at the Coloproctological Outpatient Clinic of Ferrara University Hospital, Italy with an appointment provided by the neurologist with a pre-established schedule (with written consent).

Device: Peristeen (Coloplast)

Interventions

Peristeen (Coloplast) DEVICE

Patients with severe intestinal dysfunction impairment (PAC QoL score ≥ 32) will be offered the adoption of the TAI (Transanal Irrigation) with Peristeen Device as a way to manage their own evacuation, replacing any other measure used until that moment (suppositoires, clisms exceptionally cc) with the exception of the possible intake of macrogols and/or prebiotics and/or probiotics which instead patients can continue. This treatment will be proposed to all patients with severe impairment of intestinal function. The TAI training with Peristeen will be carried out at the surgical clinic of the Surgical Department of the Ferrara University Hospital, Italy, by the health personnel involved in the study, usually in a single session, but more sessions may be necessary, with the continuation of the TAI for 4 weeks or with patient's exclusion from the study if the guarantees of appropriate use of the device will not be reached.

Multiple Scerosis (MS) Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be composed by 150 MS patients who will consecutively refer to the MS Outpatient Neurology Clinic at Ferrara University Hospital, Italy. The PAC-QoL questionnaire will be given to every patient. This questionnaire is a self-filled instrument validated and used in various studies to document the consequences that intestinal disorders and defecation have on everyday life. The first 50 patients with a PACQoL score ≥ 32 will be asked to be willing to enter the next phase of the study that continues at the Coloproctological Outpatient Clinic of Ferrara University Hospital, Italy with an appointment provided by the neurologist with a pre-established schedule (with written consent).

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital of Ferrara: lead

Study Sites (1)

Simona Ascanelli

Ferrara, 44121, Italy

Location

Related Publications (25)

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Biospecimen

Retention: SAMPLES WITHOUT DNA

The faecal sample will be stored at -20 C° and then it will be sent to the Laboratory of the Department of Pharmacy and Biotechnology of the University of Bologna, Italy, for the analysis of the intestinal microbiome composition.

MeSH Terms

Conditions

Multiple Sclerosis; Encopresis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Study Officials

• Simona Ascanelli

  University Hospital of Ferrara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 23, 2020
• First Posted: October 22, 2020
• Study Start: June 7, 2018
• Primary Completion: April 10, 2020
• Study Completion: April 10, 2020
• Last Updated: October 22, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)