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Escherichia Coli Strain Nissle 1917

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.

Table of Contents

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.[1]

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.[1]

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.[1]

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.[1]

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[1]

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.[1]

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:

  1. 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).
  2. Evaluate uveitis activity using SUN criteria. SUN stands for Standardization of Uveitis Nomenclature, which is a set of guidelines for describing and grading uveitis.
  3. Assess changes in optical coherence tomography (OCT) parameters. OCT is an imaging technique that provides detailed cross-sectional images of the eye.
  4. Verify the safety and tolerability of ECN.[1]

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[1]

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.[1]

Aspect Details
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

FAQ

  • What is autoimmune uveitis? Autoimmune uveitis is a type of eye inflammation that affects the middle layer of the eye. It occurs when the body's immune system mistakenly attacks healthy eye tissue, causing inflammation. This condition can lead to vision problems if left untreated.
  • How is Escherichia Coli Strain Nissle 1917 being used in this trial? Escherichia Coli Strain Nissle 1917 is being used as a probiotic supplement in this trial. Patients are given a product called Mutaflor, which contains this specific strain of bacteria. The study aims to see if taking this probiotic can help reduce uveitis flare-ups and improve overall eye health in patients with autoimmune uveitis.
  • Who can participate in this clinical trial? The trial is open to adults between 18 and 65 years of age who have been diagnosed with autoimmune anterior, intermediate, posterior, or pan-uveitis. Participants must have experienced a flare-up of uveitis within 6 months before the start of the study. However, people with infectious uveitis or those requiring an increase in systemic therapy are not eligible.
  • What are the main goals of this clinical trial? The main goals of this trial are to evaluate how effective Escherichia Coli Strain Nissle 1917 is in treating autoimmune uveitis, assess changes in visual acuity, monitor uveitis activity, evaluate changes in eye structure using optical coherence tomography (OCT), and verify the safety and tolerability of the treatment.
  • How long does the clinical trial last? The clinical trial is a 12-month follow-up study. This means that participants will be monitored and evaluated for a full year after starting the probiotic treatment. This extended period allows researchers to observe long-term effects and potential benefits of the treatment.

Ongoing Clinical Trials on Escherichia Coli Strain Nissle 1917

  • Study on the Effects of Escherichia coli Nissle 1917 in Patients with Autoimmune Uveitis

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Czechia

Glossary

  • Autoimmune uveitis: A type of eye inflammation where the body's immune system mistakenly attacks healthy eye tissue, causing inflammation in the middle layer of the eye.
  • Probiotic: Beneficial microorganisms that can provide health benefits when consumed in adequate amounts, often used to support digestive and immune health.
  • Escherichia Coli Strain Nissle 1917 (ECN): A specific strain of bacteria used as a probiotic in this clinical trial, administered through a product called Mutaflor.
  • Best-corrected visual acuity (BCVA): The clearest vision that a person can achieve with the help of corrective lenses, used to measure the effectiveness of eye treatments.
  • SUN criteria: Standardized Uveitis Nomenclature (SUN) criteria are guidelines used to assess and classify the activity and severity of uveitis.
  • Optical coherence tomography (OCT): A non-invasive imaging technique that uses light waves to take cross-section pictures of the retina, helping to diagnose and monitor various eye conditions.
  • Flare-up: A sudden worsening or recurrence of symptoms in a chronic condition, in this case, referring to episodes of increased inflammation in uveitis.
  • Anterior uveitis: Inflammation affecting the front part of the eye's middle layer, including the iris.
  • Intermediate uveitis: Inflammation primarily affecting the middle part of the eye, including the vitreous.
  • Posterior uveitis: Inflammation affecting the back part of the eye's middle layer, including the retina and choroid.
  • Pan-uveitis: Inflammation affecting all parts of the eye's middle layer, from front to back.
  • Gastro-resistant capsule: A type of medication capsule designed to resist breakdown in the stomach, allowing the contents to be released in the intestines.
  • Colony forming units (CFU): A measure used to estimate the number of viable bacteria or fungal cells in a sample, often used to quantify probiotics.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effects-of-escherichia-coli-nissle-1917-in-patients-with-autoimmune-uveitis/