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

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What is this study about?

This clinical trial is focused on studying the effects of a probiotic treatment for individuals with non-infectious uveitis, a condition that causes inflammation inside the eye. The treatment being tested is a probiotic called Mutaflor, which contains a specific strain of bacteria known as Escherichia coli Nissle 1917. This probiotic is taken orally in the form of gastro-resistant capsules, which means the capsules are designed to withstand stomach acid and release the bacteria in the intestines.

The purpose of the study is to evaluate how effective this probiotic is in managing symptoms of autoimmune uveitis, a type of uveitis that occurs when the body’s immune system mistakenly attacks its own eye tissues. Participants in the study will take the probiotic for a period of 12 months. During this time, researchers will monitor the participants to see how long it takes for the disease to relapse, or return, after the initial treatment. They will also observe the severity of any relapses and the total number of relapses that occur during the study.

Throughout the study, changes in vision will be assessed using methods like BCVA (Best Corrected Visual Acuity) and OCT (Optical Coherence Tomography), which are techniques used to measure vision clarity and the health of the retina, respectively. The study aims to provide valuable insights into whether this probiotic can be a beneficial treatment option for those suffering from autoimmune uveitis.

1 initial visit

Upon joining the study, you will attend an initial visit. During this visit, your eligibility will be confirmed based on specific criteria, such as age and recent history of uveitis flare-ups.

You will receive detailed information about the study, including its purpose and what participation involves. Any questions you have will be addressed.

2 baseline assessment

A comprehensive assessment will be conducted to establish your baseline health status. This may include eye examinations and other relevant tests.

The results of these assessments will be used to monitor your progress throughout the study.

3 medication administration

You will begin taking the study medication, Mutaflor, which contains Escherichia coli strain Nissle 1917. This is a probiotic supplement.

The medication is provided in the form of gastro-resistant capsules that you will take orally. The dosage and frequency will be explained to you during the visit.

4 regular follow-up visits

Throughout the 12-month study period, you will attend regular follow-up visits. These visits are crucial for monitoring your health and the effects of the medication.

During these visits, you will undergo various assessments, including eye examinations, to track any changes in your condition.

5 end of study visit

At the end of the 12-month period, you will have a final visit. This visit will include a comprehensive assessment similar to the baseline assessment.

The results will help determine the overall impact of the probiotic supplementation on your condition.

Who Can Join the Study?

Adults who are 18 years or older but younger than 65 years.
Have a condition called autoimmune uveitis, which is an inflammation inside the eye not caused by an infection.
Have experienced a flare-up (worsening) of uveitis within the last 6 months before the first visit of the study.
Both men and women can participate.

Who Cannot Join the Study?

Patients with any infectious disease cannot participate. This means if you have an illness caused by bacteria, viruses, or other germs, you are not eligible.
Patients who are pregnant or breastfeeding are not allowed to join the study.
Anyone with a history of severe allergic reactions to medications or vaccines is excluded. Severe allergic reactions can include symptoms like difficulty breathing or swelling of the face and throat.
Patients who have participated in another clinical trial within the last 30 days cannot take part in this study.
Individuals with autoimmune diseases other than uveitis are not eligible. Autoimmune diseases are conditions where the immune system mistakenly attacks the body.
Patients who are currently using immunosuppressive therapy are excluded. Immunosuppressive therapy involves medications that reduce the strength of the body’s immune system.
Anyone with a history of cancer in the past 5 years, except for certain skin cancers, cannot participate.
Patients with uncontrolled high blood pressure are not eligible. This means if your blood pressure is not well-managed with medication or lifestyle changes, you cannot join.
Individuals with severe liver or kidney disease are excluded. These are serious conditions affecting the liver or kidneys, which are important organs for filtering waste from the body.
Patients with mental health conditions that might interfere with their ability to participate in the study are not allowed to join.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia

Trial status

Country	Status	Recruitment Start
Czechia	Recruiting	09.06.2023

Trial locations

Investigated drugs:

Escherichia Coli Strain Nissle 1917

Escherichia coli Nissle 1917 (ECN) is a type of probiotic, which means it is a beneficial bacteria that can help maintain a healthy balance in your gut. In this clinical trial, ECN is being studied to see if it can help people with autoimmune uveitis, a condition where the immune system mistakenly attacks the eyes, causing inflammation. The idea is that by taking this probiotic, it might help reduce inflammation and improve symptoms by supporting the immune system in a positive way.

Investigated diseases:

Autoimmune uveitis

Non-infectious uveitis – Non-infectious uveitis is an inflammation of the uvea, the middle layer of the eye, which is not caused by an infection. It can affect one or both eyes and may involve other parts of the eye, such as the retina or the optic nerve. The condition can lead to symptoms like eye redness, pain, blurred vision, and light sensitivity. The inflammation can be acute, occurring suddenly and lasting for a short period, or chronic, persisting for a longer duration. Over time, non-infectious uveitis can cause complications such as cataracts, glaucoma, or vision loss if not managed properly. The progression of the disease varies, with periods of flare-ups and remissions.

Trial ID:

2024-517946-32-00

Protocol code:

VFN-MIU-2021-01

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?