Intestinal Microbiome Transplant in ALS
This 24-week study is looking at MTP-101C, a capsule made from healthy donor stool, for people with Amyotrophic Lateral Sclerosis (ALS). Researchers want to see if MTP-101C can help improve your daily function, measured by the ALS Functional Rating Scale, Revised (ALSFRS-R), and your quality of life (ALSAQ-5). They will also check for changes in a marker called Neurofilament Light Chain in your blood. You might be able to join if you are 18 or older, have a fast-progressing ALS diagnosis, and can swallow capsules. The study plans to enroll 20 participants.
- Study design
- This is a 24-week study where all 20 participants will receive the investigational product, MTP-101C. It is a Phase I/II study.
- What's involved
- You would have 4 in-person clinical visits and 4 phone visits over 24 weeks. You will also provide blood and stool samples, undergo antibiotic treatment, and a bowel preparation before taking MTP-101C capsules daily for 8 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your ALSFRS-R and Neurofilament Light Chain levels will be measured at week 24, and your quality of life will be assessed at week 24.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Intestinal Microbiome Transplant in ALS
At a glance
Conditions
NCT07017946
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Duke University Medical Center
Durham, North Carolinastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Richard Bedlack, MD, PhD · PRINCIPAL_INVESTIGATOR · Duke University
Who to contact
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Inclusion
Exclusion
What this trial measures
- ALS Functional Rating Scale, Revised (ALSFRS-R)Weeks 0, 4, 8, 12, 16, 20 and 24
The ALSFRS-R is a quickly administered (five minute) ordinal rating scale (ratings 0-4) used to determine patients' assessments of their capability and independence in 12 functional activities. The total score ranges from 0 to 48, where higher scores indicate better function.
- ALS Quality of Life (ALSAQ-5)Weeks 0, 4, 12, and 24
The overall ALSAQ-5 score ranges from 0 (best imaginable health state) to 100 (worst imaginable health state).
- Neurofilament Light Chain levelsWeeks 0, 4, 12 and 24
Neurofilament light chain levels are elevated in the spinal fluid and the blood of patients with ALS and other neurodegenerative diseases, and higher levels predict more severe disease progression.
- The Gastrointestinal Symptom Rating Scale (GSRS)Weeks 0, 4, 12, and 24
The Gastrointestinal Symptom Rating Scale (GSRS) is a 15-item questionnaire that can be used weekly to assess the severity of gastrointestinal symptoms experienced over the past week. The GSRS is designed to evaluate symptoms associated with common gastrointestinal disorders, such as reflux, abdominal pain, indigestion, diarrhea, and constipation. The questionnaire uses a seven-point Likert-type scale, with 1 representing no symptoms and 7 representing very troublesome symptoms. Higher scores on the subscales indicate more discomfort.