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Study on Rifamycin SV for Patients with Mild to Moderate Left-Sided Ulcerative Colitis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as ulcerative colitis, specifically targeting patients with mild to moderate left-sided ulcerative colitis. Ulcerative colitis is a chronic disease that causes inflammation and sores in the lining of the large intestine, which includes the colon and rectum. The study will test a new treatment called Rifamycin 1% in situ gelling solution, which is administered rectally. This treatment is being compared to a matching placebo to see if it can help patients achieve remission, meaning a reduction or disappearance of symptoms.

The purpose of the study is to evaluate the effectiveness and safety of this new treatment. Participants will receive the treatment or placebo for a period of six weeks. During this time, the study will monitor the proportion of patients who achieve clinical remission, which is defined by a specific scoring system that measures stool frequency, rectal bleeding, and endoscopic findings. The study will also look at other outcomes, such as partial remission, clinical response, and endoscopic improvement, which involves checking the inside of the colon with a camera to see if there is less inflammation.

Throughout the study, the safety of the treatment will be closely monitored by comparing the number of adverse reactions between the treatment and placebo groups. The trial aims to provide valuable information on whether this new treatment can effectively manage symptoms of ulcerative colitis and improve the quality of life for those affected by this condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Enrollment
Upon joining the study, eligibility is confirmed based on specific criteria. Participants must be adults aged 18 or older with a diagnosis of mild to moderate left-sided ulcerative colitis or ulcerative proctitis.
Participants must provide signed informed consent and demonstrate understanding of the study's nature and potential risks.
Step 2
Treatment initiation
Participants begin treatment with either the investigational product, rifamycin 1% in situ gelling solution, or a placebo. The solution is administered rectally using an enema.
The treatment involves an 80 mL dose of the solution, which is designed to gel in situ, meaning it forms a gel once inside the body.
Step 3
Treatment duration
The treatment period lasts for 6 weeks. During this time, participants are required to adhere to the administration schedule as instructed.
Step 4
Monitoring and assessment
Throughout the 6-week treatment period, participants' health and response to the treatment are monitored. This includes regular assessments of symptoms such as stool frequency and rectal bleeding.
Endoscopic evaluations are conducted to assess the condition of the colon and rectum.
Step 5
End of treatment evaluation
At the end of the 6-week period, the primary goal is to determine the proportion of participants achieving clinical remission. This is defined by a specific score on the modified Mayo scale, which measures disease activity.
Secondary evaluations include assessing partial remission, clinical response, and endoscopic improvement.

Who can join the trial?

8 criteria

Adults aged 18 years or older with a diagnosis of **mild to moderate left-sided ulcerative colitis** or **ulcerative proctitis** can participate. This means the inflammation is limited to certain parts of the colon or rectum.
Participants must provide **signed written informed consent** before joining the study. This means they agree to participate after understanding the study details.
Both **men and women** are eligible to participate.
The diagnosis of ulcerative colitis must be at least **3 months old** and confirmed by specific tests like **endoscopy** (a procedure to look inside the body) and **histology** (examining tissues under a microscope).
Women who can have children must use a **highly effective method of contraception**. This includes options like hormonal contraceptives, intrauterine devices, or having a sterile partner. Women who cannot have children or are post-menopausal must have been in that status for at least one year. A pregnancy test must be negative at the start of the study.
Participants must be able to **understand the study's purpose and risks** and be willing to follow the study's requirements.
Participants need to complete a **diary** for at least 3 consecutive days or 4 non-consecutive days within a week, not including certain days related to medical procedures.
Participants should not be taking other medicines for ulcerative colitis, except for **mesalamine** (also known as 5-ASA or mesalazine) or **sulfasalazine**, which should be on a stable dose for at least 2 weeks before the study starts.

Who cannot join the trial?

7 criteria

Patients with severe forms of ulcerative colitis cannot participate. This means if the condition is more serious than mild to moderate, they are not eligible.
Individuals who are not within the specified age range cannot join. The study is only for certain age groups.
Participants who are not able to follow the study procedures or take the study medication as required will be excluded.
People with other significant health issues that might interfere with the study results are not allowed to participate.
Pregnant or breastfeeding women are not eligible to join the study.
Anyone who has participated in another clinical trial recently may not be eligible.
Individuals with a history of allergic reactions to the study medication or similar drugs cannot participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Responsive
Semmelweis University
Budapest, Hungary
Responsive
Spitalul Clinic Judetean De Urgenta Cluj
Cluj Napoca, Romania
Responsive
Vilniaus universiteto ligonine Santaros klinikos VšĮ
Vilnius, Lithuania

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Investigated drugs

Rifamycin SV is a medication being tested in this clinical trial. It is used in a special gel form that is administered as an enema. The purpose of this medication is to help treat patients with mild to moderate left-sided ulcerative colitis. The trial aims to see if this medication can help reduce symptoms and induce remission of the disease.

Rifamycin Sodium

What is already known about the treatment

Rifamycin SV – This medication is administered as a rectal solution using an enema. It is currently being studied in a Phase II clinical trial to evaluate its effectiveness and safety for patients with mild to moderate left-sided ulcerative colitis. The main therapeutic indication is to induce clinical remission in these patients. Rifamycin SV works by inhibiting bacterial RNA synthesis, which helps reduce inflammation in the colon. It is classified as an antibiotic, specifically a rifamycin derivative.

Investigated diseases

Ulcerative Colitis – Ulcerative colitis is a chronic inflammatory condition affecting the colon, specifically the innermost lining of the large intestine and rectum. It typically begins in the rectum and can extend to involve the entire colon. The disease is characterized by periods of flare-ups and remission, where symptoms can vary in intensity. During flare-ups, individuals may experience frequent diarrhea, abdominal pain, and rectal bleeding. Over time, the inflammation can lead to the formation of ulcers in the colon lining. The progression of the disease can vary, with some individuals experiencing mild symptoms and others having more severe manifestations.