Study on Improving Small Bowel Visualization in Capsule Endoscopy for Patients Using Ascorbic Acid, Sodium Ascorbate, Potassium Chloride, and Simeticone
Prefer not to search? Our Concierge searches the trials for you.
What is this trial about?
A plain-language summary of the goals, design and what participants do
This clinical trial is focused on improving the quality of images and diagnostic accuracy during a procedure called *capsule endoscopy*, which is used to examine the small intestine. The study involves testing different preparation methods to see which one provides the best view of the small intestine's lining. Capsule endoscopy is a procedure where a small, pill-sized camera is swallowed to take pictures of the digestive tract.
Two different treatments are being tested in this study. The first is a product called *MOVIPREP*, which is an oral solution containing several substances, including *ascorbic acid*, *sodium ascorbate*, *potassium chloride*, *sodium chloride*, *sodium sulfate anhydrous*, and *macrogol 3350*. These ingredients work together as a laxative to help clean the intestines. The second treatment is *Aero-red 100 mg/ml gotas orales en solución*, which contains *simeticone*, a substance that helps reduce gas and bloating in the digestive tract.
The purpose of the study is to evaluate and compare how well these treatments clean the small intestine and improve the visibility of its lining during the capsule endoscopy. Participants will receive one of the treatments before undergoing the procedure. The study will assess the cleanliness of the small intestine, the time it takes for the capsule to travel through the digestive system, and how well patients tolerate the preparation. The goal is to find the most effective preparation method for improving the quality of images and diagnostic results in capsule endoscopy.
The research process
The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
7 criteria
- Patients must be 18 years or older.
- Patients should be scheduled for a small bowel study using capsule endoscopy. This is a procedure where a small camera inside a capsule is swallowed to take pictures of the small intestine.
- The reason for the capsule endoscopy should be part of standard clinical practice, meaning it is a common and accepted medical procedure.
- Patients must provide signed informed consent. This means they agree to the procedure and understand what it involves.
- Patients must also provide signed and dated informed consent to participate in the clinical trial, indicating they understand the trial and agree to be part of it.
- Both male and female patients can participate.
- The study does not include vulnerable populations, which means groups that might need special protection or care.
Who cannot join the trial?
11 criteria
- Patients who are not able to swallow a small camera capsule.
- Patients with a known or suspected blockage in the digestive tract, which is the path food takes through the body.
- Patients with a history of bowel surgery that might affect the movement of the capsule.
- Patients with a pacemaker or other electronic medical devices that might interfere with the capsule.
- Patients who are pregnant or breastfeeding.
- Patients with severe swallowing disorders, meaning they have trouble swallowing food or liquids.
- Patients with severe kidney or liver disease, which are conditions affecting the organs that filter waste from the body.
- Patients with severe heart disease, which affects the heart's ability to pump blood.
- Patients who have had a recent heart attack, which is when blood flow to the heart is blocked.
- Patients with severe lung disease, which affects breathing.
- Patients with any condition that the study doctors believe would make it unsafe for them to participate.
Prefer not to search? Our Concierge searches the trials for you.
Tell us about your condition – we search every trial in Europe and connect you with the right site.
We usually reply within a few days
Trial locations
Where you can join this trial
Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.
Not yet recruitingNot sure what to do next?
Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.
Investigated drugs
What is already known about the treatment
Macrogol with electrolytes and ascorbic acid (Moviprep)
Moviprep is a bowel-cleansing preparation taken by mouth as a solution, usually about two litres drunk in portions before an examination of the digestive tract. It is a standard, widely used preparation before colonoscopy and, as in this trial, before capsule endoscopy of the small intestine. Its main ingredient, macrogol 3350, is a large molecule that is not absorbed and holds water in the bowel by osmosis, which softens and flushes out the intestinal contents, while the added salts (sodium, potassium, sulfate) and vitamin C keep the body's fluid and mineral balance stable. It is classified as an osmotically acting laxative.
Simeticone
Simeticone is a medicine taken by mouth, in this trial as oral drops, before the capsule endoscopy examination. It has been used for many years to relieve bloating and trapped wind and is a common addition to bowel preparation because it improves the visibility of the intestinal lining. It is not absorbed into the body at all; it works physically in the gut by lowering the surface tension of gas bubbles and foam, making the bubbles collapse so that gas can pass and the camera gets a clear view. It is classified as an anti-foaming (antiflatulent) agent from the silicone group.
Investigated diseases
sourced from the EU Clinical Trials Register and site verification
Want to learn more about this trial or check if you can participate?