Simeticone

Clinical trials are investigating Simeticone in studies that focus on bowel preparation and image quality for endoscopy. These trials look at how well it helps doctors see the bowel and how patients respond in screening or diagnostic procedures. Target groups include people having colonoscopy or small bowel capsule endoscopy.

Table of contents

Overview of the Simeticone trials

Clinical research on Simeticone in the source data is centered on endoscopy preparation and the quality of bowel cleaning. The studies are not testing Simeticone as a treatment for a disease on its own; instead, they are looking at how it is used in preparation protocols for bowel tests.[1][2]

The main settings are small bowel capsule endoscopy and colorectal cancer screening colonoscopy. These trials aim to see whether the preparation helps doctors view the bowel more clearly and improve key diagnostic results.[1][2]

Small bowel capsule endoscopy study

One authorised interventional study, NCT2025-520671-38-00, evaluates the mucosal visualization quality and diagnostic performance of small bowel capsule endoscopy using different preparation protocols.[1] The brief summary says the goal is to compare the degree of cleaning and the visibility of the small intestine lining in patients having capsule endoscopy.[1]

This study includes 156 participants and is listed as a low intervention trial.[1] The main outcome is the degree of small bowel cleansing, measured with an accepted cleansing scale.[1]

In simple terms, this trial asks whether the preparation method helps the camera capsule take clearer pictures inside the small bowel. Better cleaning can make the test easier to read and may help doctors spot problems more reliably.[1]

Colorectal cancer screening trial

Another authorised study, NCT2025-523748-11-00, is a phase 3 randomized parallel comparative trial in people undergoing colorectal cancer screening colonoscopy.[2] The trial title states that it studies the efficacy and tolerability of a simethicone-containing evacuating solution in this setting.[2]

This study has 818 planned participants and compares two bowel preparation products, Clensia® and Citrafleet®.[2] The main outcome is the adenoma detection rate, which means the proportion of patients in whom at least one adenoma is found during colonoscopy.[2]

This endpoint matters because finding adenomas during screening is a key part of colonoscopy quality. The study is designed to see whether one preparation leads to better detection results in colorectal cancer screening.[2]

Study design, phases, and participants

The Simeticone-related studies in the source data are interventional, which means researchers assign a preparation strategy and then measure results.[1][2] One study is low intervention, while the colorectal screening trial is phase 3.[1][2]

The target populations are people scheduled for endoscopic procedures. One group is patients having small bowel capsule endoscopy, and the other is people undergoing colonoscopy for colorectal cancer screening.[1][2]

The trial data does not describe age limits, sex limits, or other detailed entry rules for these Simeticone studies. Based on the available information, participation depends on being scheduled for the specific endoscopy procedure being studied.[1][2]

Main outcomes measured in the trials

The small bowel capsule endoscopy study measures small bowel cleansing using an accepted scale.[1] This tells researchers how clean the bowel is before or during the test, which affects how well the lining can be seen.[1]

The colorectal screening study measures adenoma detection rate, which is the proportion of patients with at least one adenoma found during the procedure.[2] This is a common way to judge how effective a screening colonoscopy is at finding important bowel growths.[2]

These outcomes are practical and patient-focused. They help show whether a preparation approach improves the quality of the test and supports better diagnosis.[1][2]

What these trials mean for patients

For patients, these studies are about making endoscopy easier to interpret and more useful. In the small bowel study, the focus is on clearer capsule images, while in the colonoscopy study the focus is on finding adenomas during screening.[1][2]

The available trial data suggests that Simeticone is being studied as part of preparation strategies rather than as a stand-alone treatment. The main question is whether it helps improve the quality of bowel cleansing and the results of the endoscopy test.[1][2]

Trial IDPhaseCondition studiedStatusEnrollment
2025-520671-38-00Low InterventionComparison of diagnostic tools; small bowel capsule endoscopy preparationAuthorised156
2025-523748-11-00Phase 3Colorectal cancer early detectionAuthorised818

Ongoing Clinical Trials on Simeticone

  • Study on Preventing Constipation After Hip Fracture Surgery Using Bisacodyl and a Drug Combination for Post-Surgery Patients

    Recruiting

    1 1 1 1
    Investigated diseases:
    Denmark
  • A study comparing the effectiveness of a simeticone drug combination and a sodium picosulfate drug combination for bowel preparation in patients undergoing colorectal cancer screening.

    Recruiting

    1 1 1 1
    Investigated diseases:
    Spain
  • Study of Fecal Microbiota Transplantation combined with atezolizumab and bevacizumab in patients with unresectable liver cancer who progressed after initial treatment

    Recruiting

    1 1 1
    Investigated diseases:
    Italy
  • Study on Improving Small Bowel Visualization in Capsule Endoscopy for Patients Using Ascorbic Acid, Sodium Ascorbate, Potassium Chloride, and Simeticone

    Not yet recruiting

    1 1 1 1
    Spain
  • Efficacy and Safety of Mannitol Compared to Plenvu for Bowel Preparation in Patients Undergoing Elective Colonoscopy

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Belgium Italy Poland Spain Sweden

Glossary

  • Clinical trial: A planned research study in people. It is used to test whether a medical approach works and whether it is safe.
  • Interventional study: A study in which researchers assign a treatment or preparation and then measure the results.
  • Phase 3: A later stage of clinical research that usually includes many participants and compares how well a treatment or preparation works.
  • Low intervention: A study with a small amount of extra risk beyond usual care. The treatment or procedure is close to normal medical practice.
  • Colonoscopy: A test where a doctor looks inside the large bowel with a flexible tube and camera.
  • Capsule endoscopy: A test where a person swallows a small camera capsule that takes pictures inside the digestive tract.
  • Bowel cleansing: Preparing the bowel so it is as empty as possible before an endoscopy test.
  • Adenoma: A type of growth in the bowel that can be found during screening. Finding it is important because it may affect future cancer risk.
  • Adenoma detection rate: The proportion of people in a study who have at least one adenoma found during colonoscopy.
  • Mucosal visualization: How clearly the inner lining of the bowel can be seen during a test.

References

  1. https://clinicaltrials.gov/study/2025-520671-38-00
  2. https://clinicaltrials.gov/study/2025-523748-11-00