Clinical trial of fecal bacteria transplantation in the treatment of multiple sclerosis

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100048094

Enrollment

Unknown

Registered

2021-06-30

Start date

2021-06-30

Completion date

Unknown

Last updated

2022-03-07

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

Conditions

Multiple Sclerosis

Interventions

DMTs control group:Disease-Modifying Therapy (DMTs)

FMT group:Disease-Modifying Therapy (DMTs) + Fecal Microbiota Transplantation (FMT)

Eligibility

Sex/Gender

All

Age

20 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Aged 20 to 60 years old; 2. Meet the 2017 McDonald disease diagnostic criteria; 3. The subtype of the disease is relapsing-remitting multiple sclerosis (RRMS); 4. MS disease duration greater than 2 year;The number of recurrences per year > 2; 5. EDSS score: 3-6; 6. Use of DMTs > 1 month.

Exclusion criteria

Exclusion criteria: 1. Multiple sclerosis subtypes other than RRMS; 2. Combined with tumors or other autoimmune, infectious, and central nervous diseases; 3. Combined with intestinal diseases; 4. Presence of history of bowel surgery; 5. Heavy use of immunosuppressive agents in the past 3 months; 6. Combined with severe cardiovascular and cerebrovascular diseases and organ dysfunction; 7. Chronic use of antibiotics.

Design outcomes

Primary

Measure	Time frame
EDSS score;9-hole test;MRI;Fecal metabolites;Blood inflammatory cells;	—

Countries

China

Contacts

Public ContactZhang Cunjin

Drum Tower Hospital, Medical School of Nanjing University

zhangcunjin516@163.com+86 13645196561

Outcome results

None listed

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