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

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What is this study about?

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.

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.

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.

3 treatment duration

The treatment period lasts for 6 weeks. During this time, participants are required to adhere to the administration schedule as instructed.

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.

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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centrul Medical Sana S.R.L. Bucharest Romania
Spitalul Clinic Judetean De Urgenta Cluj Cluj Napoca Romania

Other Sites

Site Name City Country Status
Pauls Stradins Clinical University Hospital Riga Latvia
Institutul Regional De Gastroenterologie Hepatologie Prof. Dr. Octavian Fodor Cluj Cluj Napoca Romania
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos Kaunas Lithuania
Dc-Med Michal Kowalski sp.k. Swidnica Poland
Clinexpert Kft. Budapest Hungary
Digestive Diseases Centre Gastro SIA Riga Latvia
Vilniaus universiteto ligonine Santaros klinikos VšĮ Vilnius Lithuania
Semmelweis University Budapest Hungary
Pratia S.A. Skorzewo Poland
Ko-Med Centra Kliniczne Sp. z o.o. Lublin Poland
Multiprofile Hospital For Active Treatment Vita Ltd. Sofia Bulgaria
Mind Klinika Kft. Budapest Hungary
EMC Instytut Medyczny S.A. Poznan Poland
WIP Warsaw IBD Point Profesor Kierkuś Warsaw Poland
Gvbrhguxj Sgerfj Constanta Romania
Wcoi Tvvzde Chwyyvl Hicarttn Tallin Estonia
Uazpb Mtifma Rabu Ruse Bulgaria
Mrfjdpf cioosk Afhtrmszh hfiuek mpwqjhdx riqcyqfvfu Ezxg Sofia Bulgaria
Uiyhm Tujoxkrc Yzfurkljrgp Sofia Bulgaria
Citgnai Maailrep Lgykpof Jhvygp Łlfx Chojnice Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Not recruiting
31.01.2024
Estonia Estonia
Not recruiting
31.01.2024
Hungary Hungary
Not recruiting
31.01.2024
Latvia Latvia
Not recruiting
31.01.2024
Lithuania Lithuania
Not recruiting
31.01.2024
Poland Poland
Not recruiting
31.01.2024
Romania Romania
Not recruiting
31.01.2024

Trial locations

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.

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.

Trial ID:
2023-506917-23-00
Protocol code:
CB-01-35/01
Trial Phase:
Therapeutic exploratory (Phase II)

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