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The effects of synbiotic product on gut microbiota changes in patients with multiple sclerosis treated with dimethyl fumarate

The effects of synbiotic product on gut microbiota changes in patients with multiple sclerosis treated with dimethyl fumarate: A randomized, double-blind, placebo-control clinical trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20190804044429N12
Enrollment
60
Registered
2024-07-06
Start date
2024-06-21
Completion date
Unknown
Last updated
2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple sclerosis. Multiple sclerosis

Interventions

Intervention 1: Intervention group: Patients are prescribed one Familact (synbiotic) capsule every night following their initial disease diagnosis for a period of six months after their main meal. Int

Sponsors

Mazandaran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Adults over 18 years of age with a recent diagnosis of MS or a first attack consistent with a high-risk primary clinical syndrome based on the McDonald 2017 criteria Expanded disability status scale less than 4.5 Candidate for dimethyl fumarate

Exclusion criteria

Exclusion criteria: Pregnancy Antibiotic use in the past month Consumption of any product and supplement that contains probiotics during the last three months Consumption of omega-3 and other antioxidants during the last month Systemic glucocorticoid use during the last month breastfeeding

Design outcomes

Primary

MeasureTime frame
Changes in the bacteria in the digestive tract of people with MS. Timepoint: At the beginning of treatment and month 6. Method of measurement: PCR.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMonireh Ghazaeian

Mazandaran University of Medical Sciences

Ghazaeianm@gmail.com+98 11 3334 3989

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026