The Effect of a Probiotic Administration as an add-on Tre... | NCT07168772

Studies
The Effect of a Probiotic Administration as an add-on Treatment in Multiple Sclerosis

NCT07168772

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Status

Recruiting

Last Update Posted

Sep 23, 2025Actual

Enrollment

80Estimated

Phase

Not Applicable

Conditions

Multiple Sclerosis

Interventions

Lactibane Iki
Placebo

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 10, 2025Actual

Primary Completion Date

Dec 31, 2027Estimated

Completion Date

Dec 31, 2027Estimated

First Submitted Date

Aug 26, 2025

First Submission Date that Met QC Criteria

Sep 4, 2025

First Posted Date

Sep 11, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 22, 2025

Last Update Posted Date

Sep 23, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lactibane Iki	Experimental		Dietary Supplement: Lactibane Iki
Placebo	Placebo Comparator		Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lactibane Iki	Dietary 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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Increase in the percentage of Treg cells		6 months

Secondary Outcomes

Measure	Description	Time Frame
Immunological profile (percentage of positive cells): Th1 cells; Th17cells; Breg cells; DCs	Immunological profile studied by flow cytometry (percentage of positive cells): Th1 cells; Th17cells; Breg cells; DCs.	6 months
Serum levels of NfL, GFAP, cytokines and CRP

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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
Patients showing a maximum of two new lesions on MRI prior to inclusion
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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases