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Simeticone

Clinical trials investigating Simeticone are looking at how it may help in bowel preparation and image quality during endoscopy. These studies focus on patients undergoing capsule endoscopy or colonoscopy, and they measure things like cleansing quality, visibility, and diagnostic performance.

Table of contents

Trial overview

The trial data shows one study that is directly described as a simethicone-containing preparation study for colorectal cancer screening colonoscopy.[1] This study compares two bowel preparation products and measures how well they help find adenomas, which are small bowel growths seen during screening.[1]

The other studies in the data are not about Simeticone itself, but they give context for the type of research being done in bowel preparation and endoscopy.[2][3][4] These studies focus on cleansing quality, visibility, and diagnostic performance during bowel tests.[2]

Who is being studied

The main target group for the Simeticone-related study is people having colorectal cancer screening colonoscopy.[1] This means adults who are being checked for early signs of bowel cancer, even if they do not have symptoms.[1]

Another study in the data includes patients who are scheduled for small bowel capsule endoscopy, which is a test that uses a swallowed camera capsule to look at the small bowel.[2] That study compares preparation protocols to see which one gives better cleaning and clearer views of the bowel lining.[2]

A further trial in the data involves patients after hip fracture surgery, but that study is about laxatives and not Simeticone.[3] It is included in the source data, but it does not directly study Simeticone.[3]

What is being measured

The key result in the Simeticone-related colonoscopy study is the adenoma detection rate.[1] This is the proportion of people in each study group who have at least one adenoma found during colonoscopy.[1]

In the small bowel capsule endoscopy study, the main result is the degree of small bowel cleansing using an accepted cleansing scale.[2] The study also looks at mucosal visualization quality and diagnostic performance, which means how well the doctor can see the bowel lining and how useful the test is for finding problems.[2]

In the colonoscopy preparation study that compared mannitol with Plenvu®, the main result was whether bowel cleansing was adequate, using the BBPS score, which is a standard bowel cleanliness score.[4] A score of 6 or more, with each bowel section scoring at least 2, was considered adequate in that study.[4]

In the liver cancer study, the main results were safety and disease control after fecal microbiota transplantation, which is not a Simeticone study but is part of the source set.[5] The safety result counted serious side effects, and the efficacy result looked at disease control at 12 weeks.[5]

Trial phases and status

The Simeticone-related colonoscopy study is a Phase 3 trial and is listed as authorised.[1] Phase 3 studies usually involve larger groups of participants and compare how well different preparation methods work in real clinical use.[1]

The small bowel capsule endoscopy study is listed as a low intervention study and is authorised.[2] This means the trial uses a lower-risk research approach and focuses on comparing preparation methods already used in practice.[2]

The colonoscopy preparation study comparing mannitol and Plenvu® is also Phase 3 and is completed.[4] It included 520 participants and was designed as a randomized, parallel-group, endoscopist-blinded non-inferiority study.[4]

The hip fracture laxative study is Phase 3 and authorised, while the liver cancer study is Phase 2 and authorised.[3][5] These trials are not direct Simeticone studies, but they show the broader research context in the source data.[3][5]

Main studies in the data

CLEAN+ is the main Simeticone-related study in the data.[1] It is a randomized parallel comparative trial in people having colorectal cancer screening colonoscopy, and it compares two bowel preparation products with the goal of measuring adenoma detection rate.[1]

The small bowel capsule endoscopy study looks at different preparation protocols to improve how clean and visible the small bowel is during the test.[2] Its purpose is to compare the quality of cleansing and imaging, not to treat disease.[2]

The CLEARWAY study compares mannitol with Plenvu® for elective colonoscopy preparation and includes 520 participants.[4] Its main goal is to show that one preparation is not worse than the other for achieving adequate bowel cleansing, which is called a non-inferiority design.[4]

The hip fracture study asks what laxatives work best after surgery, with the main result being whether people need rescue medication within 72 hours.[3] The liver cancer study tests fecal microbiota transplantation added to existing cancer therapy and measures safety and disease control at 12 weeks.[5]

What these trials may mean for patients

For patients, these trials are mainly about making endoscopy tests easier to read and more useful.[1][2] Better bowel preparation can help doctors see the bowel lining more clearly and may improve the chance of finding important changes such as adenomas.[1][2]

These studies also show that researchers are comparing different preparation plans in real clinical settings, such as screening colonoscopy and capsule endoscopy.[1][2] The main patient benefit being tested is better test quality, not symptom relief or long-term treatment.[1][2]

The source data does not give detailed information about how patients are selected for the Simeticone-related study beyond the fact that they are scheduled for screening colonoscopy.[1] It also does not provide detailed results, so the focus here is on the study goals and outcome measures.[1][2]

Trial ID Phase Condition studied Status Enrollment
2025-523748-11-00 Phase 3 Colorectal cancer early detection Authorised 818
2025-520671-38-00 Low Intervention Comparison of diagnostic tools Authorised 156
2024-513871-42-00 Phase 3 Hip fracture Authorised 375
2025-521451-23-00 Phase 3 Elective colonoscopy preparation Completed 520
2023-510504-45-00 Phase 2 Unresectable hepatocellular carcinoma Authorised 15

FAQ

  • What are the Simeticone clinical trials studying? The trials are studying bowel cleansing and how well doctors can see the bowel lining during endoscopy. They look at whether preparation plans that include Simeticone improve visibility and diagnostic quality.
  • Who may take part in these trials? The target groups are patients scheduled for small bowel capsule endoscopy or colorectal cancer screening colonoscopy. The trial data also includes adults having elective colonoscopy as part of bowel preparation research.
  • What phase are the Simeticone trials in? The Simeticone trial listed here is a Phase 3 study. Phase 3 means the treatment plan is being tested in a larger group to compare how well it works.
  • What do the trials measure as the main result? The main results include the degree of small bowel cleansing, the quality of mucosal visualization, and the adenoma detection rate. These measures help show how well the bowel is prepared and how useful the test is.
  • Are these studies about treatment or diagnosis? They are mainly diagnostic and preparation studies, not treatment studies. The goal is to improve endoscopy quality and help doctors find bowel changes more clearly.

Igangværende kliniske forsøg for Simeticone

  • Hvilke afføringsmidler virker bedst mod forstoppelse efter hofteoperation?

    Rekrutterer

    1 1 1 1
    Undersøgte sygdomme:
    Undersøgte lægemidler:
    Danmark

  • Undersøgelse af effekten af en kombination af simeticon og en lægemiddelkombination bestående af natriumpikosulfat, magnesiumoxid og citronsyre til forberedelse af screening for tyktarmskræft.

    Rekrutterer

    1 1 1 1
    Undersøgte sygdomme:
    Undersøgte lægemidler:
    Spanien

  • Undersøgelse af fækal mikrobiota transplantation kombineret med atezolizumab og bevacizumab hos patienter med ikke-operabel leverkræft, som ikke har responderet på førstelinjebehandling

    Rekrutterer

    1 1 1
    Undersøgte sygdomme:
    Undersøgte lægemidler:
    Italien

  • Sammenligning af forskellige tarmrensningsmetoder før kapselkamera-undersøgelse af tyndtarmen

    Rekrutterer endnu ikke

    1 1 1 1
    Undersøgte lægemidler:
    Spanien

  • Undersøgelse af mannitol sammenlignet med lægemiddelkombination til tarmrensning hos patienter, der skal have foretaget en planlagt koloskopi

    Rekrutterer ikke

    1 1 1 1
    Undersøgte sygdomme:
    Undersøgte lægemidler:
    Belgien Italien Polen Spanien Sverige

Ordliste

  • Bowel cleansing: How well the bowel is emptied and cleaned before an endoscopy so the doctor can see the lining clearly.
  • Capsule endoscopy: A test where a small camera in a capsule is swallowed to take pictures of the small bowel.
  • Colonoscopy: A test that lets the doctor look inside the large bowel with a flexible camera.
  • Mucosa: The inner lining of the bowel that the doctor needs to see clearly during endoscopy.
  • Visualization: How clearly the doctor can see the bowel during the test.
  • Diagnostic performance: How well a test helps find problems or disease.
  • Phase 3: A later stage of research where a study is done in a larger group to compare how well a method works.
  • Adenoma: A small growth in the bowel that can matter because it may be found during cancer screening.
  • Adenoma detection rate: The proportion of patients in whom at least one adenoma is found during colonoscopy.
  • Enrolment: The number of people planned to join the study.

Referencer

  1. https://clinicaltrials.gov/study/2025-523748-11-00
  2. https://clinicaltrials.gov/study/2025-520671-38-00
  3. https://clinicaltrials.gov/study/2024-513871-42-00
  4. https://clinicaltrials.gov/study/2025-521451-23-00
  5. https://clinicaltrials.gov/study/2023-510504-45-00