Effect of Probiotics on Relapsing-Remitting Multiple Sclerosis

NCT ID: NCT07346924

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2025-03-01

Brief Summary

This study aimed to assess the effect of probiotic supplementation on fatigue, quality of life, disability, depression and inflammatory markers in patients with relapsing-remitting multiple sclerosis (RRMS).

Patients were randomized to receive probiotics plus standard therapy The study sought to determine whether modulation of gut microbiota could provide additional clinical and immunological benefits in RRMS management.

Detailed Description

This trial was conducted as part of a Doctoral (PhD) thesis at the Department of Neurology, Cairo University

The purpose of the trial was to evaluate the potential effects of probiotic supplementation on clinical and biological outcomes in patients with relapsing-remitting multiple sclerosis (RRMS).

Multiple sclerosis is a chronic inflammatory and demyelinating disease of the central nervous system, in which immune dysregulation and gut microbiota imbalance may play a key role.

Recent evidence suggests that probiotics could exert beneficial immunomodulatory and anti-inflammatory effects, potentially improving patient outcomes.

In this randomized controlled study, patients with RRMS received either probiotic supplementation or standard therapy alone for a defined period.

The primary outcomes included changes in fatigue quality of life, disability and depressive symptoms Secondary outcomes included alterations in inflammatory biomarkers such as cytokines and other immune mediators.

The results of this study are expected to provide additional insights into the role of gut microbiota modulation as an adjunctive approach in the management of multiple sclerosis.

No major protocol deviations occurred, and the study adhered to ethical standards approved by the local ethics committee.

Conditions

Multiple Sclerosis (MS) Relapsing Remitting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Probiotic Group

probiotic dietary supplements

Group Type: ACTIVE_COMPARATOR

Probiotic dietary supplement

Intervention Type: DIETARY_SUPPLEMENT

The probiotic group only had regular daily probiotic intake in the form of 2 cups of yogurt rich in probiotics - each cup 105 gram containing 5 to 10 billion Colony forming unit (CFU)/mg of Bifidobacterium animalis DN-173 010, Bifidobacterium lactis DN 173 010, Bifidobacterium lactis CNCM 1-2494, Lactobacillus bulgaricus, Streptococcus thermophiles, Lactococcus lactis and yeast tablets 400 mg one tablet per day for each patient each tablet containing 6 billion CFU/mg of probiotics Saccharomyces cerevisiae and Saccharomyces boulardii, along 3 months from the start of the study

Controlled group

standard treatment only

Group Type: PLACEBO_COMPARATOR

Standard medical treatment

Intervention Type: OTHER

standard medical treatment

Interventions

Probiotic dietary supplement

The probiotic group only had regular daily probiotic intake in the form of 2 cups of yogurt rich in probiotics - each cup 105 gram containing 5 to 10 billion Colony forming unit (CFU)/mg of Bifidobacterium animalis DN-173 010, Bifidobacterium lactis DN 173 010, Bifidobacterium lactis CNCM 1-2494, Lactobacillus bulgaricus, Streptococcus thermophiles, Lactococcus lactis and yeast tablets 400 mg one tablet per day for each patient each tablet containing 6 billion CFU/mg of probiotics Saccharomyces cerevisiae and Saccharomyces boulardii, along 3 months from the start of the study

Intervention Type: DIETARY_SUPPLEMENT

Standard medical treatment

standard medical treatment

Intervention Type: OTHER

Other Intervention Names

yogurt

Eligibility Criteria

Inclusion Criteria

• Clinically definite MS patients with a diagnosis of relapsing remitting multiple sclerosis according to revised McDonald criteria 2017.
• EDSS score of ≤ 4

Exclusion Criteria

• Progressive MS either; primary progressive MS or secondary progressive MS
• Patients who had relapses and glucocorticoid therapy within the past 30 days.
• Pregnancy and women who were lactating within the prior six month
• Patients taking antibiotics
• History of gastroenteritis and bowel surgery over the past month, inflammatory bowel disease
• Presence of diabetes (type I & type II) or diseases causing significant nutritional status impairment (malignancy, chronic infections)
• Patients who have changed their disease modifying drugs in the past 6 months prior to study
• Impaired cognition that limited ability to complete the questionnaires. Addiction to drugs or alcohol.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Foraysa Mohammed Talaat

Faculty of medicine, Cairo university

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of medicine

Cairo, , Egypt

Countries

Egypt

Other Identifiers

MD-221-2023

Identifier Type: -

Identifier Source: org_study_id