Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Minnesota | OTHER |
Not provided
Not provided
Not provided
Not provided
This is a 24-week study of intestinal microbiome transplant in people with ALS. All participants will be evaluated clinically in person for 4 visits. Blood and mailed/ fresh stool samples will also be collected. Blood samples will be used to determine changes in neurofilament light chain over time. Stool samples will be processed for microbiome analysis. Participants will have phone visits to further evaluate safety and tolerability. They will then undergo antibiotic conditioning and a standard bowel preparation before being assigned to the investigational product, MTP-101C .
This is a 24-week Phase I/II study of MTT in people with Amyotrophic Lateral Sclerosis. All participants will be evaluated clinically in person at weeks 0, 4, 12, and 24 visits. Blood and mailed/ fresh stool samples will be collected at weeks 0, 4, 8, 12, and 24. Blood samples will be used to determine changes in neurofilament light chain over time. Stool samples from weeks 0, 4,8, 12, and 24 will be processed by molecular methods (metagenomics and metatranscriptomics) for microbiome analysis. Participants will also have phone visits at weeks 1, 8, 16, and 20, which will be used to further evaluate safety and tolerability and the ALSFRS-R score.
Participants will first undergo antibiotic conditioning with oral vancomycin 250 mg twice daily for 10 days. Neomycin 500 mg twice daily will be added to the last 3 days of vancomycin. This will be followed by ingestion of a standard bowel preparation with magnesium citrate. Participants will then ingest 2 capsules of MTP-101C daily for 3 days, then 1 capsule of MTP-101C daily for 8 weeks.
All participants will be assigned to the investigational product.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MTP-101C administration | Experimental | MTP-101C is a freeze-dried encapsulated universal donor microbiome-based formulation. Participants will ingest 2 capsules daily for 3 days then 1 capsule daily. This is preceded by antibiotic conditioning with a combination of vancomycin and neomycin, followed by a bowel purgative with magnesium citrate depending upon underlying comorbidities. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MTP-101C | Drug | MTP-101C is a freeze-dried encapsulated formulation of fecal microbiota purified from the stool of healthy donors. |
|
| Measure | Description | Time Frame |
|---|---|---|
| ALS Functional Rating Scale, Revised (ALSFRS-R) | 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. | Weeks 0, 4, 8, 12, 16, 20 and 24 |
| ALS Quality of Life (ALSAQ-5) | The overall ALSAQ-5 score ranges from 0 (best imaginable health state) to 100 (worst imaginable health state). | Weeks 0, 4, 12, and 24 |
| Neurofilament Light Chain levels | 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. | Weeks 0, 4, 12 and 24 |
| The Gastrointestinal Symptom Rating Scale (GSRS) | 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. | Weeks 0, 4, 12, and 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Microbiome composition | Participants will also be sent collection kits to collect intestinal samples and return by mail. Data analyses will be performed to study the microbiome composition before and during the intervention. | Screening/Baseline, Week 4, Week 12, and Week 24 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Richard Bedlack, MD, PhD | Contact | 919-613-2681 | ALSresearch@duke.edu | |
| Michelle Ward, RN | Contact | 919-613-2681 | ALSresearch@duke.edu |
| Name | Affiliation | Role |
|---|---|---|
| Richard Bedlack, MD, PhD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Recruiting | Durham | North Carolina | 27705 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000690 | Amyotrophic Lateral Sclerosis |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D016472 | Motor Neuron Disease |
Not provided
Not provided
All participants receive the investigational product.
Not provided
Not provided
Not provided
Not provided
| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |