CompletedNot a drug-phase studyMS (type not specified)NCT06475183

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 22 months ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • Bouchard Belgian Dark Chocolate Probiotic Napolitains, containing bifidobacterium longum

What it measured

Main measures

  • peripheral blood mononuclear cell (PBMC) profile: Change in Regulatory T (Treg) cells

    baseline (week 0) to week 6

  • peripheral blood mononuclear cell (PBMC) profile: Change in T helper (TH) cells

    baseline (week 0) to week 6

  • peripheral blood mononuclear cell (PBMC) profile: Change in T helper Th17 cells

    baseline (week 0) to week 6

  • Change in serum microbial metabolites

    baseilne (week 0) to week 6

Other measures (4)

  • Change in Modified Fatigue Impact Scale-5 Impact Scale

    week 0, week 6

    FatigueQuality of life (reported by participants)
  • Change in Patient-Determined Disability Scale (PDDS)

    week 0, week 6

    Quality of life (reported by participants)
  • Change in Bowel Control Scale

    week 0, week 6

    Bladder, bowel and sexual functionQuality of life (reported by participants)
  • Change in Multiple Sclerosis Rating Scale- Revised (MSRS-R) Patient-Determined Disease Steps Scale

    week 0, week 6

    Quality of life (reported by participants)

Who could take part

MS (type not specified) · 18 to 45

Inclusion Criteria: * Multiple Sclerosis (MS) subjects, first-degree relatives of MS subjects, or healthy controls * Age 18-45 Exclusion Criteria: * diabetes * tree nut allergy * pregnancy

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 study is to assess the effects of probiotics on persons with multiple sclerosis (MS), persons at higher genetic risk for MS (first degree family members of persons with MS), and healthy controls. Participants will be asked to consume probiotic containing chocolates (Bouchard Belgian Dark Chocolate Probiotic Napolitains containing 10 billion CFUs of bifidobacterium longum per day) for 6 weeks. Participants will undergo blood draws before and after the 6 weeks of probiotic containing chocolate and microbial metabolites and immune markers will be compared before and after the probiotics, as well as between groups.

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History

    1. Started

      Jun 2024

    2. Main results due

      Dec 2024

    3. Finished

      Dec 2024

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