In short
A clinical trial is currently underway to investigate the potential benefits of Escherichia Coli Strain Nissle 1917, a probiotic, in treating autoimmune uveitis. This 12-month study aims to evaluate the effectiveness and safety of this innovative approach for patients with non-infectious uveitis, a condition affecting the eye's middle layer. The trial focuses on how this probiotic might help manage symptoms and reduce disease flare-ups in adults with various forms of autoimmune uveitis.
At a glance
- Study Title
- 12-month study of probiotic effects in non-infectious uveitis treatment
- Main Objective
- Evaluate efficacy of Escherichia coli Nissle 1917 (ECN) in patients with autoimmune uveitis
- Condition Studied
- Non-infectious uveitis (autoimmune uveitis)
- Treatment
- Mutaflor (containing Escherichia coli Strain Nissle 1917)
- Dosage
- Maximum daily dose: 4 billion CFU
- Administration Route
- Oral
- Study Duration
- 12 months
- Primary Endpoint
- Time to first disease relapse from baseline visit
- Key Inclusion Criteria
- Adults 18-65 years with autoimmune uveitis, flare-up within 6 months prior to baseline
- Key Exclusion Criteria
- Infectious uveitis, active uveitis requiring increased systemic therapy
What is Escherichia coli Strain Nissle 1917 (ECN)?
Escherichia coli Strain Nissle 1917, also known as ECN, is a type of beneficial bacteria being studied for its potential health benefits. It is classified as a probiotic, which means it's a live microorganism that may provide health benefits when consumed in adequate amounts. ECN is the active ingredient in a medication called Mutaflor, which comes in the form of gastro-resistant hard capsules.
Medical Conditions Treated with ECN
The primary focus of the current study is on the use of ECN for treating autoimmune uveitis. Uveitis is an inflammation of the uvea, the middle layer of the eye that includes the iris, ciliary body, and choroid. When it's described as "autoimmune," it means the inflammation is caused by the body's immune system mistakenly attacking its own tissues.
It's important to note that while ECN is being studied for uveitis, it's currently classified as an antidiarrheal microorganism. This suggests it may have multiple potential uses in medicine.
Study Details
A clinical trial is currently underway to investigate the effects of ECN in patients with autoimmune uveitis. This is a 12-month follow-up study, meaning researchers will observe patients for a full year after they start taking the probiotic. The study aims to determine if ECN can help in the treatment of non-infectious uveitis.
Eligibility Criteria
To participate in this study, patients must meet certain criteria:
- Be adults between 18 and 65 years old
- Have autoimmune anterior, intermediate, posterior, or pan-uveitis (these terms refer to different parts of the eye affected by inflammation)
- Have experienced a flare-up of uveitis within 6 months before the start of the study
Patients cannot participate if they have:
- Uveitis caused by an infection
- Active uveitis that requires an increase in systemic therapy or the start of biological treatment
There may be other exclusion criteria not listed here.
Study Objectives
The main goal of this study is to evaluate how effective ECN is in treating patients with autoimmune uveitis. Additionally, researchers aim to:
- Assess changes in best-corrected visual acuity (BCVA). This is a measure of the sharpness of a person's vision when wearing their best possible vision correction (like glasses or contact lenses).
- Evaluate uveitis activity using SUN criteria. SUN stands for Standardization of Uveitis Nomenclature, which is a set of guidelines for describing and grading uveitis.
- Assess changes in optical coherence tomography (OCT) parameters. OCT is an imaging technique that provides detailed cross-sectional images of the eye.
- Verify the safety and tolerability of ECN.
Study Endpoints
To measure the effectiveness of ECN, researchers will look at several endpoints:
- Primary endpoint: The time to the first disease relapse from the start of the study. This will help determine how long ECN can potentially keep uveitis under control.
- Secondary endpoints:
- The severity of the first relapse according to the SUN system
- The total number of relapses during the study
- Changes in OCT parameters
Dosage and Administration
In this study, ECN is being administered as Mutaflor, a gastro-resistant hard capsule. The maximum daily dose is 4 billion CFU (Colony Forming Units), which is a measure of the number of viable bacteria in the probiotic. The treatment period lasts for 12 months, and the medication is taken orally.