Probiotic Intervention for People With Multiple Sclerosis

NCT07304713 | Completed

• 1 other identifier: ER46295102
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis

Keywords

Feasibility; probiotic; Acceptability; Multiple Sclerosis

Outcome Measures

Primary Outcomes (5)

• Recruitment

  Percentage of eligible participants recruited from those who had expressed interest.

  8-weeks

• Retention

  Percentage of participants who completed all aspects of the study.

  23-weeks

• Adherence

  Described as the percentage of doses taken. This was recorded with a paper diary and contained information on reason for missed/late doses.

  12-weeks

• Safety/Side effects

  Participants recorded all potential side effects in a diary, as well as being asked by the researcher at 1,2 and 6 weeks.

  12-weeks

• Acceptability

  Acceptability was measured using the 7 domains of the Sehkon acceptability framework, both via self-report questionnaire on the Qualtrics platform and during online qualitative focus groups.

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

Secondary Outcomes (7)

• Overall Quality of life of participants

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

• Health-related quality of life

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

• Participant mental wellbeing

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

• Participant functional ability

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

• Participant Gut Symptoms

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

Other Outcomes (3)

• Physical Activity

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

• Diet Diary

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

• Stool sample acceptability

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

Study Arms (1)

Probiotic

EXPERIMENTAL

Daily 70ml probiotic

Dietary Supplement: Probiotic

Interventions

Probiotic DIETARY_SUPPLEMENT

12-week probiotic intervention (70ml daily)

Probiotic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 years or over.
• Living in the United Kingdom.
• Self-reported clinical diagnosis of MS.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sheffield Hallam University: lead

Study Sites (1)

Sheffield Hallam University

Sheffield, South Yorkshire, United Kingdom

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Mixed-methods

Study Record Dates

• First Submitted: November 28, 2025
• First Posted: December 26, 2025
• Study Start: June 20, 2023
• Primary Completion: November 24, 2023
• Study Completion: November 24, 2023
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)