Health TrialsbyHealthPanel

Intestinal Microbiome Transplant in ALS

ConditionAmyotrophic Lateral Sclerosis ALS
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDuke University

About this trial

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 .

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of ALS according to Gold Coast Criteria

Age: 18+ years at enrollment

Fast-progressing (ALSFRS-R change of at least 1.5 points per month between last 2 measurements at screening)

Modestly but not severely affected (ALSFRS-R score at or above 24 at screening)

Disqualifiers

Concurrent illness or laboratory abnormalities that could confound the measurement of ALS progression or the microbiome or interfere with the ability to complete the study.

Taking probiotics, nutraceuticals, or herbal remedies within 2 weeks of screening

Taking antibiotics within 3 months of screening.

Taking any investigational study drug within 30 days of screening or five half-lives of the prior agent.

Trial design

Design model

Single group

Treatments tested in this trial

  • MTP-101C

    Drug

    MTP-101C is a freeze-dried encapsulated formulation of fecal microbiota purified from the stool of healthy donors.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: MTP-101C administrationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Weeks 0, 4, 8, 12, 16, 20 and 24
2

ALS Quality of Life (ALSAQ-5)

The overall ALSAQ-5 score ranges from 0 (best imaginable health state) to 100 (worst imaginable health state).

Time frame
Weeks 0, 4, 12, and 24
3

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.

Time frame
Weeks 0, 4, 12 and 24
4

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.

Time frame
Weeks 0, 4, 12, and 24

Secondary outcomes

1

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.

Time frame
Screening/Baseline, Week 4, Week 12, and Week 24

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Duke University

Lead sponsor

University of Minnesota

Collaborator

Source ClinicalTrials.gov
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