Effect of Probiotics on Relapsing-Remitting Multiple Sclerosis (PRO-RRMS)

January 8, 2026 updated by: Foraysa Mohammed Talaat, Cairo University

Probiotics as a Promising Adjunct: Improving Fatigue, Quality of Life, Disability, Mood and Inflammatory Markers in Relapsing-Remitting Multiple Sclerosis: A Randomized, Double-blind, Controlled Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Faculty of medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Probiotic Group
probiotic dietary supplements
Dietary supplement: 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
Other Names:
  • yogurt
Placebo Comparator: Controlled group
standard treatment only
Other: Standard medical treatment
standard medical treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with improving in fatigue
Time Frame: 3 months
changes in fatigue status using modified fatigue impact scale which range from 0 to 84 where high scores worse outcome
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inflammatory biomarkers
Time Frame: 3 months
alterations in inflammatory biomarkers such as cytokines and other immune mediators
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Actual)

September 1, 2024

Study Completion (Actual)

March 1, 2025

Study Registration Dates

First Submitted

December 25, 2025

First Submitted That Met QC Criteria

January 8, 2026

First Posted (Estimated)

January 16, 2026

Study Record Updates

Last Update Posted (Estimated)

January 16, 2026

Last Update Submitted That Met QC Criteria

January 8, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MD-221-2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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