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A randomized controlled clinical trial of fecal bacteria transplantation for multiple sclerosis

A randomized controlled clinical trial of fecal bacteria transplantation for multiple sclerosis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800018057
Enrollment
Unknown
Registered
2018-08-28
Start date
2019-01-01
Completion date
Unknown
Last updated
2018-09-03

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

Conditions

Multiple sclerosis

Interventions

Sponsors

Affiliated Hospital of Guangdong Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: (1) Aged 18-55 years; (2) MS is diagnosed according to the diagnostic criteria of McDonald (Revised Edition 2010); (3) the course of the disease was 2-10 years; (4) the baseline of the EDSS score was 2-5 points before the treatment; (5) relapse remission has recurred in the past 12 months. (6) secondary progressive type had recurrence within the past 12 months, or the EDSS score increased by 1 points. (7) there were recurrences in primary progression or GAD enhancement in head MRI.

Exclusion criteria

Exclusion criteria: (1) diseases that interfere with clinical assessment, such as disability (not caused by MS); (2) severe depression; (3) pregnant, lactating women or those who are planning to conceive; (4) do not agree to sign the patient's informed consent; (5) relapse within 30 days. (6) antibiotic treatment in the last 30 days

Design outcomes

Primary

MeasureTime frame
The EDSS increased by 1 points or more in 60 weeks and continued for 12 weeks.;

Secondary

MeasureTime frame
The progression of upper limb functional disability increased by 20% at 60 weeks and continued for 12 weeks.;the ratio of 25 step walking speed of the subjects decreased by 20% and lasted for 12 weeks in 60 week.;Recurrence times;Annual recurrence rate;new lesion in MRI;

Countries

China

Contacts

Public ContactZhou Liu

Affiliated Hospital of Guangdong Medical University

liuzhou@gdmu.edu.cn+86 13543558835

Outcome results

None listed

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