Effect of synbiotic and anti-inflammatory-antioxidant rich diet in progressive multiple sclerosis

Phase 3

Recruiting

• Conditions: Multiple Sclerosis.; Multiple sclerosis

• Registration Number: IRCT20141108019853N7
• Lead Sponsor: Esfahan University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Progressive MS Patients based on EDSS criteria (RRMS, PPMS, PRMS), who agree to participate in the study.
Aged between 20-60 years old
Having basic literacy
Mental acceptance for participation and compliance

Exclusion Criteria

Non-compliance with diet and supplement (adherence rate below 80 %)
participation in other clinical trials at one time
The occurrence of acute & serious medical conditions (urgent surgeries, accidents)
COVID-19 infection (during the study)
Taking immunomodulatory drugs - commons in relapsing-remitting MS- during and 6 months before the intervention (such as interferons, Sphingosine-1-phosphate receptor modulators, monoclonal antibodies, dimethyl fumarate)
Regular consumption of anti-anxiety and anti-depressant drugs during and six months before the intervention
Taking the other forms of synbiotic, probiotic, prebiotic, and postbiotic supplements during and 6 months before the intervention
Taking antibiotics during and 2 months before the intervention
Taking corticosteroids (for example methylprednisolone in doses more than 30 mg/day) and adrenocorticotropin hormone as full doses during and 6 months before the intervention
Regular smoking (at least two cigarettes per day)
Patients with pancreatitis, sepsis, dialysis, chronic diarrhea, and inpatient individuals with or without central venous catheter
Patients who are waiting for abdominal surgeries
Patients with acute immune deficiencies such as AIDS and cancers
Patients with short bowel syndrome or at risk for mesenteric ischemia
Patients who are in pregnancy or breastfeeding period or those with pregnancy attempt
The unwillingness to cooperate

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fecal level of calprotectin. Timepoint: At baseline and after 16 weeks. Method of measurement: Enzyme Linked Immuno Sorbent Assay (ELISA) kits.;Disease activity. Timepoint: At baseline and after 16 weeks. Method of measurement: scoring form of Expanded Disability Status Scale (EDSS).;Fatigue severity. Timepoint: At baseline and after 16 weeks. Method of measurement: Modified Fatigue Impact Scale 21 items (MFIS) questionnaire.