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

RecruitingNAAges 18 Years - 60 YearsAllHospital Universitari Vall d'Hebron Research Inst…
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * Patients aged 18-60 years, inclusive * Diagnosis of RRMS (McDonald Criteria 2024, Montalban et al) * Expanded disability status scale (EDSS) score less than or equal to 5.5 * Patients receiving a first line treatment with teriflunomide, dimethyl fumarate, interferon-beta or glatiramer acetate at a stable dose, for at least 24 weeks, or patients who are not receiving treatment because they do not want to receive a disease modifying therapy after the investigator has informed them of their possible respective benefits and possible adverse events * Not active RRMS patients (Lubin et al, 2014) for whom a switch in background therapy is not anticipated, based on the Investigator's judgment. * 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 Exclusion Criteria: * Relapse the month before enrollment * 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.
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What it tests

  • Lactibane Iki
  • Placebo
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Where

1 site
Centre d'Esclerosi Mútiple de Catalunya (Cemcat)
Barcelona, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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