Study on Improving Small Bowel Visualization in Capsule Endoscopy for Patients Using Ascorbic Acid, Sodium Ascorbate, Potassium Chloride, and Simeticone
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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 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.
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Investigated drugs
What is already known about the treatment
Investigated diseases
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