NCT07168772 The Effect of a Probiotic Administration as an add-on Treatment in Multiple Sclerosis
| NCT ID | NCT07168772 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospital Universitari Vall d'Hebron Research Institute |
| Condition | Multiple Sclerosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-07-10 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2025-07-10 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Frequently Asked Questions
Who can join the NCT07168772 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 55 Years, studying Multiple Sclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07168772 currently recruiting?
Yes, NCT07168772 is actively recruiting participants. Visit ClinicalTrials.gov or contact Hospital Universitari Vall d'Hebron Research Institute to inquire about joining.
Where is the NCT07168772 trial being conducted?
This trial is being conducted at Barcelona, Spain.
Who is sponsoring the NCT07168772 clinical trial?
NCT07168772 is sponsored by Hospital Universitari Vall d'Hebron Research Institute. The trial plans to enroll 80 participants.
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