MSFrontier

Probiotic Intervention for People With Multiple Sclerosis

Feasibility and Acceptability of a 12-week Probiotic Intervention to Improve Health Outcomes for People With Multiple Sclerosis: A Single-arm Trial
CompletedNot a drug-phase studyMS (type not specified)NCT07304713

We could not find results for this trial

I know where the results are

What it found

No result found

We found no results in the registry or in papers.

This trial finished 2 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • Probiotic

What it measured

Main measures

  • Recruitment

    8-weeks

  • Retention

    23-weeks

    Feasibility

  • Adherence

    12-weeks

    Quality of life (reported by participants)

  • Safety/Side effects

    12-weeks

    Safety

  • Acceptability

    0-weeks (baseline) and 12-week (Follow-up)

    Feasibility

Other measures (7)

  • Overall Quality of life of participants

    Baseline (0-weeks) and Follow-up (12-week)

    Quality of life (reported by participants)

  • Health-related quality of life

    Baseline (0-weeks) and Follow-up (12-weeks)

    Walking and mobilityPainMood and sleepQuality of life (reported by participants)

  • Participant mental wellbeing

    Baseline (0-weeks) and Follow-up (12 weeks)

  • Participant functional ability

    Baseline (0-weeks) and Follow-up (12-weeks)

    Brain volume lossFatigueWalking and mobilityArm and hand function

  • Participant Gut Symptoms

    Baseline (0-weeks) and Follow-up (12-weeks)

    Bladder, bowel and sexual functionPainQuality of life (reported by participants)

  • Participant fatigue

    Baseline (0-weeks) and Follow-up (12-weeks).

    Thinking and memoryFatigue

  • Cognitive function (processing speed)

    Baseline (0-weeks) and Follow-up (12-weeks)

    Thinking and memory

Who could take part

MS (type not specified) · 18 and over

Inclusion Criteria: * Adults aged 18 years or over. * Living in the United Kingdom. * Self-reported clinical diagnosis of MS. Exclusion Criteria: * Symptom relapse or hospital admission in the prior four weeks. * Rapidly progressing MS defined as two of more disabling relapses in the last year. * Immunocompromised and requiring steroids (not including PwMS taking anti-CD20 monoclonal antibodies [Ocrevus or Kesimpta]). * Type 2 diabetes, Cardiovascular disease, kidney disease, chronic gastrointestinal tract health issues. * Pregnant or lactating. * Dysphagia. * Antibiotic use in the prior three months. * Pro-biotic use in the prior four weeks. * Use of food supplements which target gut health in the prior four weeks. * Medically advised not to use a probiotic.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

The goal of this single-arm, mixed methods trial is to learn if it is feasible and acceptable to take a probiotic for 12-weeks in people with Multiple Sclerosis. The main question[s] it aims to answer [is/are]: * Is it feasible and acceptable for people with MS to take a probiotic for 12-weeks? * Explore impact on health outcomes? Participants will. * Drink 70ml probiotic drink daily as prescribed for 12-weeks. * All data collection will be done remotely. * Before and after 12-weeks participants will complete an online questionnaire (Acceptability, lifestyle behaviour, symptoms, quality of life). * Provide a stool sample to analyse microbiome changes. * Take a short online cognitive test. * Participate in a focus group.

Papers

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    History

      1. Started

        Jun 2023

      2. Main results due

        Nov 2023

      3. Finished

        Nov 2023

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