Status:
ACTIVE_NOT_RECRUITING
Calorie Restriction in Multiple Sclerosis
Lead Sponsor:
Federico II University
Collaborating Sponsors:
Fondazione Italiana Sclerosi Multipla
Conditions:
Multiple Sclerosis, Relapsing-Remitting
Caloric Restriction
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
There is a strong relationship between metabolic state and immune tolerance through a direct control exerted on immune cells by specific intracellular nutrient-energy sensors. An increased "metabolic ...
Detailed Description
Multiple sclerosis (MS) is an autoimmune disorder characterized by central nervous system (CNS) inflammation, demyelination, and axonal damage. Its pathogenesis consists of an initial T cell priming a...
Eligibility Criteria
Inclusion
- Subjects with early diagnosis (no more than 2 years) of RR-MS according to the revised McDonald (2017) criteria;
- Subjects naïve-to-treatment;
- Subjects with EDSS between 0-5.5;
- No use of oral or systemic corticosteroids or adrenocorticotropic hormone (ACTH) within 30 days prior to screening visit;
- Subjects with BMI \> 22 kg/m2 and BMI \< 28 kg/m2;
- Willing to collect a food diary for one week and to donate a blood and stool samples;
- No antibiotic treatment within 3 months of enrolment;
- No immunosuppressive therapy;
- Signed informed consent.
Exclusion
- Pregnancy and breast-feeding;
- History of alcohol or drug abuse;
- Serious psychiatric disorders;
- Any major medical problem that in the opinion of the investigator could bias the results (e.g. HIV infection) or affect adherence to the protocol;
- Subjects with inadequate haematological function (defined by leukocyte ≤ 2,0 x 109; platelets \<100 x 109; haemoglobin \<12 g/dl for female and \<13 g/dl for male), liver function (defined by aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase \> 2.0 times upper limit of normal), thyroid function (according to physician's discretion);
- Known hypersensitivity to gadolinium;
- Any other condition that would prevent the subject from undergoing a contrast-enhanced MRI scan;
- Any contra-indication according to the specific first line treatment for MS.
Key Trial Info
Start Date :
July 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2025
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT04042415
Start Date
July 14 2020
End Date
September 1 2025
Last Update
August 20 2024
Active Locations (1)
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1
Neuromed - Istituto Neurologico Mediterraneo Pozzilli
Pozzilli, IS, Italy, 86077