PEG-Asc Vs. SPMC for Bowel Preparation in Capsule-based Procedures

Summary

This clinical research study is designed to find out which of two different types of bowel preparation works best for people undergoing capsule-based endoscopy procedures. Capsule colonoscopy and pan-intestinal capsule endoscopy ("panendoscopy") are newer, less invasive tests that use a small camera inside a capsule that is swallowed, instead of a traditional colonoscopy that requires a long flexible tube. These tests allow doctors to see the inside of the colon, and in the case of panendoscopy, also the small intestine. They are especially useful when a regular colonoscopy cannot be completed or when doctors need to investigate conditions such as Crohn's disease, anemia, or unexplained bleeding.

For these capsule procedures to work well, the bowel needs to be as clean as possible, since the capsule cannot wash or suction away any stool or bubbles. This makes the type of bowel preparation very important, but at present there are no clear recommendations about which preparation to use. Standard preparations often involve large volumes of liquid that patients may find difficult to drink. In recent years, ultra-low-volume preparations (1 liter or less) have been developed to improve patient comfort and make the preparation process easier.

In this study, we are comparing two of these ultra-low-volume options: Polyethylene Glycol plus Ascorbic Acid (PEG-Asc), a 1-liter solution and Sodium Picosulfate with Magnesium Citrate (SPMC), a powder mixed with water.

We want to see which of these two preparations provides better bowel cleansing for capsule procedures, while also checking which is easier for patients to tolerate.

A total of 220 adult patients referred for capsule colonoscopy or panendoscopy were enrolled and randomly assigned to receive either PEG-Asc or SPMC. Both groups followed a split-dose schedule, with part of the preparation taken the evening before and part on the morning of the test, along with additional instructions including dietary restrictions, laxative tablets, and clear liquids.

The main questions this study is trying to answer are:

1. \- Which preparation results in better cleaning of the bowel, allowing clearer pictures from the capsule?
2. \- Which preparation is easier for patients to tolerate, with fewer side effects such as nausea or vomiting?
3. \- Does the type of preparation affect whether the capsule can complete the examination and reach the end of the colon?

By answering these questions, this study hopes to improve the effectiveness and comfort of capsule endoscopy procedures. The results will help doctors decide which bowel preparation to recommend, making these less invasive tests more reliable and accessible for patients in the future.

Conditions

• Bowel Preparation Solution

Interventions

DRUG

Polyethylene Glycol plus Ascorbic Acid (PEG-Asc)

Participants receive a split-dose bowel preparation with 1 L polyethylene glycol plus ascorbic acid (PEG-Asc). The first dose is administered at 20:00 the evening before the procedure (500 mL PEG-Asc solution consumed over 1 hour, followed by 500 mL clear liquids). The second identical dose is taken at 06:00 on the day of the capsule procedure.

DRUG

Sodium Picosulfate with Magnesium Citrate (SPMC)

Participants receive sodium picosulfate with magnesium citrate (SPMC) in a split-dose regimen. The first sachet is dissolved in 150 mL water and followed by 1.5-2 L of clear fluids the evening before the procedure, and the second sachet is taken with the same fluid regimen on the morning of the procedure.

Sponsors & Collaborators

• Unidade Local de Saúde do Alto Ave, EPE

  lead OTHER

Principal Investigators

• José B Cotter, MD PhD · Unidade Local de Saúde do Alto Ave

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-01-01

Primary Completion

2025-06-30

Completion

2025-08-30

Countries

• Portugal

Study Locations