NCT07168772

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

The Effect of a Probiotic Administration as an add-on Treatment in Multiple Sclerosis: a Randomized, Double-blind, Placebo-controlled Clinical Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Hospital Universitari Vall d'Hebron Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Lactibane Iki	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.
OTHER	Placebo	Patients will receive a placebo (starch) sachet twice a day for six months.

Timeline

• Start date: 2025-07-10
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2025-09-11
• Last updated: 2025-09-23

Locations

1 site across 1 country: Spain