Effect of supplementation in treatment of patients with multiple sclerosis

Clinical trial of the effect of probiotic supplementation compared with the placebo on disease severity, mental health, insulin resistance, inflammatory factors and biomarkers of oxidative stress in patients with multiple sclerosis

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2017082234497N2

Enrollment

Registered

2017-09-15

Start date

2017-08-17

Completion date

Unknown

Last updated

2019-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple sclerosis. Multiple sclerosis

Interventions

Intervention 1: Intervention group: Probiotic capsule containing four strains of Bifidobacterium infantis (2×109 CFU/g), Lactobacillus reuteri (2×109 CFU/g), Lactobacillus casei (2×109 CFU/g), lactoba

Eligibility

Sex/Gender

All

Age

20 Years to 60 Years

Inclusion criteria

Inclusion criteria: Patients with multiple sclerosis identified according to McDonald criteria Course of disease relapsing–remitting MS (RRMS) EDSS =4.5

Exclusion criteria

Exclusion criteria: Primary progressive MS (PPMS) Secondary progressive MS (SPMS) Relapse and glucocorticoid therapy during the past one month Pregnancy Women who were lactating within the prior six month Nephrolithiasis Consumption of of probiotic or synbiotic during the past three month

Design outcomes

Primary

Measure	Time frame
EDSS. Timepoint: At the beginning of the study and after 16 weeks of intervention. Method of measurement: Physical Examination by Neurologist.;High sensitivity C-reactive protein. Timepoint: At the beginning of the study and after 16 weeks of intervention. Method of measurement: Elisa kit.	—

Secondary

Measure	Time frame
Interleukin 6. Timepoint: At the beginning of the study and after 16 weeks of intervention. Method of measurement: ELISA kit.;Interleukin 10. Timepoint: At the beginning of the study and after 16 weeks of intervention. Method of measurement: ELISA kit.;Tumor necrosis factor alpha. Timepoint: At the beginning of the study and after 16 weeks of intervention. Method of measurement: ELISA kit.;Insulin. Timepoint: At the beginning of the study and after 16 weeks of intervention. Method of measurement: ELISA.;Fasting blood sugar. Timepoint: At the beginning of the study and after 16 weeks of intervention. Method of measurement: Enzymatic kit.;Nitric oxide. Timepoint: At the beginning of the study and after 16 weeks of intervention. Method of measurement: Spectrophotometry.;8-hydroxydeoxyguanosine. Timepoint: At the beginning of the study and after 16 weeks of intervention. Method of measurement: ELISA kit.;Superoxide dismutase. Timepoint: At the beginning of the study and after 16 weeks of intervention. Method of measurement: ELISA kit.;Glutathione. Timepoint: At the beginning of the study and after 16 weeks of intervention. Method of measurement: Spectrophotometry.;Malondialdehyde. Timepoint: At the beginning of the study and after 16 weeks of intervention. Method of measurement: Spectrophotometry.;Total antioxidant capacity. Timepoint: At the beginning of the study and after 16 weeks of intervention. Method of measurement: Spectrophotometry.;Depression. Timepoint: At the beginning of the study and after 16 weeks of intervention. Method of measurement: Beck Depression Inventory.;General Health. Timepoint: At the beginning of the study and after 16 weeks of intervention. Method of measurement: General Health Questionnaire (28 item).;Depression. Timepoint: At the beginning of the study and after 16 weeks of intervention. Method of measurement: depression, anxiety and stress scale.	—

Measure

Time frame

Interleukin 6. Timepoint: At the beginning of the study and after 16 weeks of intervention. Method of measurement: ELISA kit.;Interleukin 10. Timepoint: At the beginning of the study and after 16 weeks of intervention. Method of measurement: ELISA kit.;Tumor necrosis factor alpha. Timepoint: At the beginning of the study and after 16 weeks of intervention. Method of measurement: ELISA kit.;Insulin. Timepoint: At the beginning of the study and after 16 weeks of intervention. Method of measurement: ELISA.;Fasting blood sugar. Timepoint: At the beginning of the study and after 16 weeks of intervention. Method of measurement: Enzymatic kit.;Nitric oxide. Timepoint: At the beginning of the study and after 16 weeks of intervention. Method of measurement: Spectrophotometry.;8-hydroxydeoxyguanosine. Timepoint: At the beginning of the study and after 16 weeks of intervention. Method of measurement: ELISA kit.;Superoxide dismutase. Timepoint: At the beginning of the study and after 16 weeks of intervention. Method of measurement: ELISA kit.;Glutathione. Timepoint: At the beginning of the study and after 16 weeks of intervention. Method of measurement: Spectrophotometry.;Malondialdehyde. Timepoint: At the beginning of the study and after 16 weeks of intervention. Method of measurement: Spectrophotometry.;Total antioxidant capacity. Timepoint: At the beginning of the study and after 16 weeks of intervention. Method of measurement: Spectrophotometry.;Depression. Timepoint: At the beginning of the study and after 16 weeks of intervention. Method of measurement: Beck Depression Inventory.;General Health. Timepoint: At the beginning of the study and after 16 weeks of intervention. Method of measurement: General Health Questionnaire (28 item).;Depression. Timepoint: At the beginning of the study and after 16 weeks of intervention. Method of measurement: depression, anxiety and stress scale.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactZatollah Asemi

Kashan University of Medical Sciences

asemi_z@kaums.ac.ir+98 31 5546 3378

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026