Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:31 PM
Ignite Modification Date:
2025-12-24 @ 1:31 PM
NCT ID:
NCT04599595
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04599595
Study Brief:
Protocol Section:
NCT04599595