NCT07168772

Brief Summary

It is a randomized, double-blind, placebo-controlled clinical trial whose general objective of this study is to determine the effects of probiotic administration in multiple sclerosis patients. 80 patients with relapsing-remitting multiple sclerosis will be enrolled in the study. Patients will be randomly assigned to receive either a probiotic (n=40) or a placebo (n=40) stratified by type of medication, gender and use of hormonal contraceptive treatment. They will receive a probiotic (Lactibane Iki) or placebo sachet twice a day for six months.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P75+ for not_applicable multiple-sclerosis

Timeline
19mo left

Started Jul 2025

Typical duration for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress35%
Jul 2025Dec 2027

Study Start

First participant enrolled

July 10, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 11, 2025

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

September 23, 2025

Status Verified

September 1, 2025

Enrollment Period

2.5 years

First QC Date

August 26, 2025

Last Update Submit

September 22, 2025

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

  • Increase in the percentage of Treg cells

    6 months

Secondary Outcomes (4)

  • Immunological profile (percentage of positive cells): Th1 cells; Th17cells; Breg cells; DCs

    6 months

  • Serum levels of NfL, GFAP, cytokines and CRP

    6 months

  • Serum and fecal levels of SCFAs

    6 months

  • Microbiota composition analysis

    6 months

Study Arms (2)

Lactibane Iki

EXPERIMENTAL
Dietary Supplement: Lactibane Iki

Placebo

PLACEBO COMPARATOR
Other: Placebo

Interventions

Lactibane IkiDIETARY_SUPPLEMENT

Patients will receive a probiotic sachet twice a day for six months. The probiotic, Lactibiane iki (Pileje; Paris, France), is composed of Bifidobacterium lactis LA 304, Lactobacillus acidophilus LA 201, and Lactobacillus salivarius LA 302 and contains 4x10E10 CFU/sachet.

Lactibane Iki
PlaceboOTHER

Patients will receive a placebo (starch) sachet twice a day for six months.

Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients aged 18-55 years, inclusive
  • Diagnosis of RRMS (McDonald Criteria 2017 and Lublin phenotype classification 2014)
  • Expanded disability status scale (EDSS) score less than or equal to 5.5
  • Patients receiving a first line treatment with teriflunomide or dimethyl fumarate at a stable dose, for at least 24 weeks, or patients who are not receiving treatment because they do not want to receive a DMT after the investigator has informed them of their possible respective benefits and possible adverse events
  • At enrollment, the patient is not expected to require a change in DMT
  • Females of childbearing potential must have a negative urine pregnancy test result prior to initiation of study product
  • For females of childbearing potential: agreement to use adequate contraceptive methods during the treatment period
  • Ability to comply with the study protocol
  • Patients must sign and date a written informed consent prior to entering the study

You may not qualify if:

  • Relapse the month before enrollment
  • Presence of a new lesion, indicative of radiological activity, on the MRI performed before starting the study
  • Use of corticosteroids the month before enrollment
  • Use of antibiotics three months before enrollment
  • Taking other forms of symbiotic, probiotic, prebiotic and postbiotic supplements three months before enrollment
  • Patients suffering from any type of bowel disease
  • Pregnant or breastfeeding or intending to become pregnant during the study.
  • Be menopausal
  • Be a smoker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre d'Esclerosi Mútiple de Catalunya (Cemcat)

Barcelona, Barcelona, 08035, Spain

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2025

First Posted

September 11, 2025

Study Start

July 10, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

September 23, 2025

Record last verified: 2025-09

Locations

ES(1)