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 study about?

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.

1 initial preparation

Begin by taking the prescribed medication MOVIPREP, which is an oral solution. This medication contains several active ingredients including ascorbic acid, sodium ascorbate, potassium chloride, sodium chloride, sodium sulfate anhydrous, and macrogol 3350. It is used to clean the small intestine before the capsule endoscopy.

Follow the specific instructions provided for the dosage and frequency of MOVIPREP to ensure proper preparation for the procedure.

2 additional preparation

Take Aero-red, which is an oral drop solution containing simeticone. This medication helps reduce gas bubbles in the stomach and intestines, improving the quality of the images obtained during the capsule endoscopy.

Follow the dosage instructions provided for Aero-red to ensure optimal results.

3 capsule endoscopy procedure

Undergo the capsule endoscopy procedure. This involves swallowing a small capsule with a camera that will take images of the small intestine as it passes through.

The primary goal is to evaluate the degree of cleaning and visualization of the small intestine mucosa.

4 monitoring and data collection

During the procedure, several parameters will be monitored, including the gastric transit time (GTT) and small bowel transit time (STT). These times measure how long it takes for the capsule to travel through different parts of the digestive system.

The diagnostic yield of the capsule endoscopy will be assessed by identifying any clinically significant lesions.

5 completion and feedback

After the procedure, complete a questionnaire to assess the tolerability of the preparation. This feedback helps evaluate the degree of acceptance or non-acceptance of the preparation process.

The study is considered complete when the capsule reaches the blind spot during the recording time.

Who Can Join the Study?

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 Study?

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.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Hospital Universitario Principe De Asturias	Alcala De Henares	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not yet recruiting	17.05.2021

Trial locations

Investigated drugs:

Capsule Endoscopy is a procedure that uses a small, pill-sized camera to take pictures of the digestive tract, particularly the small intestine. This trial aims to assess how well different preparation methods clean and allow for clear visualization of the small intestine’s lining during this procedure.

Small Intestinal Bacterial Overgrowth (SIBO) – This condition occurs when there is an abnormal increase in the number of bacteria in the small intestine. It can lead to symptoms such as bloating, diarrhea, and abdominal pain. The excess bacteria can interfere with the digestion and absorption of nutrients. Over time, this can result in malnutrition and weight loss. SIBO is often associated with other conditions that affect the digestive system. It can be diagnosed through specific breath tests that measure the presence of hydrogen or methane.

Trial ID:

2025-520671-38-00

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on Improving Small Bowel Visualization in Capsule Endoscopy for Patients Using Ascorbic Acid, Sodium Ascorbate, Potassium Chloride, and Simeticone

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?