NCT07346924

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 25, 2025

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 16, 2026

Completed
Last Updated

January 16, 2026

Status Verified

January 1, 2026

Enrollment Period

8 months

First QC Date

December 25, 2025

Last Update Submit

January 8, 2026

Conditions

Multiple Sclerosis (MS) Relapsing Remitting

Keywords

fatiguedepressiondisability

Outcome Measures

Primary Outcomes (1)

  • 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

    3 months

Secondary Outcomes (1)

  • Inflammatory biomarkers

    3 months

Study Arms (2)

Probiotic Group

ACTIVE COMPARATOR

probiotic dietary supplements

Dietary Supplement: Probiotic dietary supplement

Controlled group

PLACEBO COMPARATOR

standard treatment only

Other: Standard medical treatment

Interventions

Probiotic dietary supplementDIETARY_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

Also known as: yogurt
Probiotic Group
Standard medical treatmentOTHER

standard medical treatment

Controlled group

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine

Cairo, Egypt

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-RemittingFatigueDepression

Interventions

Yogurt

Condition Hierarchy (Ancestors)

Multiple SclerosisDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Cultured Milk ProductsMilkBeveragesDiet, Food, and NutritionPhysiological PhenomenaFermented FoodsDairy ProductsFoodFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Faculty of medicine, Cairo university

Study Record Dates

First Submitted

December 25, 2025

First Posted

January 16, 2026

Study Start

January 1, 2024

Primary Completion

September 1, 2024

Study Completion

March 1, 2025

Last Updated

January 16, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)