Effect of supplementation in treatment of patients with multiple sclerosis

Clinical trial of the effect of probiotic supplementation compared with the placebo on metabolic profiles in patients with multiple sclerosis

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT201511015623N59

Enrollment

Registered

2015-12-02

Start date

2015-11-01

Completion date

Unknown

Last updated

2019-11-05

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 Lactobacillus acidophilus (2×109 CFU/g), Lactobacillus casei (2×109 CFU/g), Bifidobacterium bifidum (2×109 CFU/g) and L

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Inclusion criteria

Inclusion criteria: Ages between 18 and 55 The course of RRMS diagnosed according to McDonald criteria EDSS score =4.5

Exclusion criteria

Exclusion criteria: Women who were pregnant Lactating during the past six months Nephrolithiasis for the past 5 years Menopaused women with irregular menstruation Unwillingness to utilize appropriate contraceptive tools.

Design outcomes

Primary

Measure	Time frame
EDSS. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Physical Examination by Neurologist.;High-sensitivity C-reactive protein. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: ELISA kit.	—

Secondary

Measure	Time frame
Insulin. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;Fasting blood sugar. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Triglycerides. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;HDL-cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Malondialdehyde. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Nitric oxide. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Glutathione. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Total antioxidant capacity. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Insulin resistance. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Calculation using HOMA formula.;General health. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Standard questionnaire GHQ-28.;Depression. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: depression, anxiety and stress scale.;Depression. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Beck Depression Inventory.	—

Measure

Time frame

Insulin. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;Fasting blood sugar. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Triglycerides. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;HDL-cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Malondialdehyde. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Nitric oxide. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Glutathione. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Total antioxidant capacity. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Insulin resistance. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Calculation using HOMA formula.;General health. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Standard questionnaire GHQ-28.;Depression. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: depression, anxiety and stress scale.;Depression. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Beck Depression Inventory.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactZatollah Asemi

Kashan University of Medical Sciences

asemi_r@yahoo.com+98 31 5562 0608

Outcome results

None listed

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