Effects of fecal microbiota transplantation on movement disorders (amyotrophic lateral sclerosis)

Exploring fecal microbiota transplantation in the treatment of amyotrophic lateral sclerosis and its impact on disease progression: a double-blind, placebo-controlled, randomized clinical trial

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2200064504

Enrollment

Unknown

Registered

2022-10-10

Start date

2022-10-10

Completion date

Unknown

Last updated

2023-05-15

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

Conditions

Amyotrophic lateral sclerosis

Interventions

Experimental group:Donor FMT

Control group:Autologous FMT

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Signed informed consent form; 2. Between 18-65 years of age; 3. Patients diagnosed with a laboratory supported, clinically "probable" or "definite" amyotrophic lateral sclerosis according to the Revised El Escorial criteria.

Exclusion criteria

Exclusion criteria: 1. A first-degree relative or multiple relatives diagnosed with ALS; 2. Diagnosed with severe depression or psychosis (DSM-V criteria); 3. Any of the following situations occurred in the past 3 months: hospital admission, anesthesia or sedation, abdominal trauma; 4. Primary gastrointestinal diseases (except chronic gastritis); 5. History of previous abdominal or anorectal surgery (resulting in abnormal bowel structure); 6. Any of the following occurred within the past 3 months: gastrointestinal or respiratory infection, food poisoning; 7. Use probiotics or antibiotics in the past 3 months; 8. Contraindications for colonoscopy; 9. Other immune diseases or clinical immunosuppressants; 10. Drug abuse; 11. Malignant tumors; 12. Any serious comorbidities that may interfere with the learning process determined by the treating physician; 13. Pregnancy or insufficient anti-pregnancy during the test period.

Design outcomes

Primary

Measure	Time frame
ALS Functional Rating Scale–Revised (ALSFRS-R) score ;	—

Secondary

Measure	Time frame
Constipation scoring system (CSS);Gastrointestinal symptom rating scale (GSRS);Fatigue severity scale (FSS);The Hamilton anxiety scale (HAMA);The Hamilton depression scale, HAMD;Mini-mental state examination (MMSE);Gastrointestinal pathology ;Gut microbiome;Modified Norris Scale scores;ALS Assessment Questionnaire score-40;Forced Vital Capacity;The Power of Grip and Pinch Test;Milano-Torino (MiToS) functional staging;	—

Measure

Time frame

Constipation scoring system (CSS);Gastrointestinal symptom rating scale (GSRS);Fatigue severity scale (FSS);The Hamilton anxiety scale (HAMA);The Hamilton depression scale, HAMD;Mini-mental state examination (MMSE);Gastrointestinal pathology ;Gut microbiome;Modified Norris Scale scores;ALS Assessment Questionnaire score-40;Forced Vital Capacity;The Power of Grip and Pinch Test;Milano-Torino (MiToS) functional staging;

—

Countries

China

Contacts

Public ContactJunfang Teng

The First Affiliated Hospital of Zhengzhou University

fccdingxb@zzu.edu.cn+86 371 67962102

Outcome results

None listed

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