What the trial was testing
The KARMET enrolled 151 patients with parkinson's disease. The study was sponsored by Enterin Inc. and tracked outcomes across the full group of patients who matched the trial's eligibility profile.
It was initial testing (phase 2). Trials at this stage are designed to produce evidence regulators and physicians can act on — not just observations to follow up later.
What the results showed
People on ENT-01 went from less than 1 bowel movement per week to more than 3 per week.
Annals of internal medicine · 2022 · NCT03781791
These findings — that up from less than 1 per week before treatment — were published in the Annals of internal medicine and represent the headline result of the study.
Researchers tracked outcomes across 151 patients enrolled in the trial. The result was consistent enough across the group that the team felt confident reporting it.
What this means for patients
For patients with parkinson's disease, this result changes the calculus on what to ask their care team about. Whether it changes day-to-day care depends on factors like disease subtype, prior treatments, and where the patient is in their care journey.
What you can do now
This was an early-stage study and ENT-01 is not yet FDA-approved. The treatment was well-tolerated with mainly nausea and diarrhea as side effects. If you have Parkinson's and struggle with constipation, ask your doctor about open trials testing ENT-01 or other options to manage this symptom.
Eligibility for the treatments mentioned above depends on specific test results and clinical history. Bring this summary, the trial name, and your most recent labs or pathology report to your next visit.
Open parkinson's disease trials
Psilocybin Therapy for Depression in Parkinson's Disease
The purpose of this study is to understand whether people with Parkinson's Disease and depression have improvement in their symptoms after psilocybin therapy.
Phase 2 Trial of Tributyrin in People With Parkinson's Disease and Cognitive Impairments
The goal of this clinical trial is to learn if taking a tributyrin supplement works to improve memory and thinking and walking and balance in adults with Parkinson disease Parkinson disease dementia. It will also learn about the safety of tributyrin supplementation. The main questions it aims to answer are: 1. Does tributyrin improve memory/thinking test scores and walking/balance ability? 2. What medical problems do participants have when taking tributyrin? Researchers will compare tributyrin to a placebo (a look-alike substance that contains no drug) to see if tributyrin works to treat Parkinson disease symptoms. Participants will: 1. Take tributyrin 3 times a day for 80-100 days 2. Complete motor and cognitive testing at the clinic before and after the supplementation period 3. Complete brain imaging (MRI scans and PET scans) before and after the supplementation period.