Multiple Sclerosis (MS) Relapsing RemittingPRO-RRMSNCT07346924
Effect of Probiotics on Relapsing-Remitting Multiple Sclerosis
A study testing Probiotic dietary supplement and Standard medical treatment in people with Multiple Sclerosis (MS) Relapsing Remitting, run by Cairo University at 1 site in Egypt.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Multiple Sclerosis (MS) Relapsing Remitting
- What is being tested?
- Probiotic dietary supplement and Standard medical treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinically definite MS patients with a diagnosis of relapsing remitting multiple sclerosis according to revised McDonald criteria 2017.
- EDSS score of ≤ 4
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Probiotics as a Promising Adjunct: Improving Fatigue, Quality of Life, Disability, Mood and Inflammatory Markers in Egyptian Relapsing-Remitting Multiple Sclerosis
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.
Read the 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.
- Being tested
- Probiotic dietary supplement, Standard medical treatment
- Keywords
- fatigue, depression, disability
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Fatigue, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic dietary supplementDietary supplement
Also called yogurt
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
Standard medical treatmentOther
standard medical treatment
| Study group | Role | What they receive |
|---|---|---|
| Probiotic Group | Active comparator | probiotic dietary supplements Receives: Dietary Supplement: Probiotic dietary supplement |
| Controlled group | Placebo comparator | standard treatment only Receives: Other: Standard medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with improving in fatigue
changes in fatigue status using modified fatigue impact scale which range from 0 to 84 where high scores worse outcome
Measured: 3 months
Secondary outcomes (1)
Inflammatory biomarkers
alterations in inflammatory biomarkers such as cytokines and other immune mediators
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start1 Jan 2024
- Primary completion1 Sep 2024
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis (MS) Relapsing RemittingStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Foraysa Mohammed Talaat, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07346924
- Sponsor's protocol ID
- MD-221-2023
- Acronym
- PRO-RRMS
- Status last verified
- Jan 2026
- First submitted
- 25 Dec 2025
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotics as a Promising Adjunct: Improving Fatigue, Quality of Life, Disability, Mood and Inflammatory Markers in Egyptian Relapsing-Remitting Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT07346924
- Acronym / sponsor ID
- PRO-RRMS / MD-221-2023
- Keywords
- fatigue, depression, disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic Group | Active comparator | Dietary Supplement: Probiotic dietary supplementprobiotic dietary supplements |
| Controlled group | Placebo comparator | Other: Standard medical treatmentstandard treatment only |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Clinically definite MS patients with a diagnosis of relapsing remitting multiple sclerosis according to revised McDonald criteria 2017.
- EDSS score of ≤ 4
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic dietary supplementAlso: yogurtThe 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 | Dietary supplement | Probiotic Group |
| Standard medical treatmentstandard medical treatment | Other | Controlled group |
Primary outcome
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
1 secondary outcome
Inflammatory biomarkers
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Multiple Sclerosis (MS) Relapsing Remitting
Active, not recruiting
Tai Chi Training for Persons With Multiple Sclerosis.
Multiple Sclerosis (MS) - Relapsing-remitting
Not yet recruitingPhase 2
A Study of Remibrutinib Using MR Imaging in Relapsing or Progressive MS
Multiple Sclerosis (MS) - Relapsing-remitting, Multiple Sclerosis (MS) Secondary Progressive
Active, not recruitingObservational study
Prospective Evaluation of De-Escalation From antiCD-20 Therapies to Dimethyl Fumarate (Tecfidera) or Diroximel Fumarate (Vumerity)
Multiple Sclerosis (MS) Relapsing Remitting
RecruitingObservational study
Brain Imaging and Immune Changes During Remibrutinib Treatment in Multiple Sclerosis.
Multiple Sclerosis (MS) - Relapsing-remitting
Recruiting
Exploration of Novel Imaging Biomarkers on OCT for Ublituximab Treatment Response in Multiple Sclerosis
Multiple Sclerosis (MS) - Relapsing-remitting
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic dietary supplement and Standard medical treatment in people with Multiple Sclerosis (MS) Relapsing Remitting, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with improving in fatigue (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.