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

NCT07206329 | Completed

• 1 other identifier: 64/2024
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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

Conditions

Bowel Preparation Solution

Keywords

Capsule Colonoscopy; Pan-intestinal Capsule Endoscopy; Bowel Cleansing; Ultra-low-volume Bowel Preparation; Polyethylene Glycol plus Ascorbic Acid; Sodium Picosulfate with Magnesium Citrate

Outcome Measures

Primary Outcomes (1)

• Adequate bowel cleansing rate assessed by CC-CLEAR scale

  Proportion of patients achieving adequate overall bowel cleansing, defined as CC-CLEAR score ≥6 with no segment scoring ≤1.

  Within 24 hours of capsule ingestion

Secondary Outcomes (4)

• Capsule completion rate

  Within 24 hours of capsule ingestion

• Patient tolerability

  Day of procedure

• Adverse events

  Within 48 hours of capsule ingestion

• Detection of clinically relevant findings

  Within 24 hours of capsule ingestion

Study Arms (2)

Polyethylene Glycol plus Ascorbic Acid (PEG-Asc)

EXPERIMENTAL

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: Polyethylene Glycol plus Ascorbic Acid (PEG-Asc)

Sodium Picosulfate with Magnesium Citrate (SPMC)

EXPERIMENTAL

Participants receive a split-dose bowel preparation with sodium picosulfate and magnesium citrate (SPMC). The first dose is administered at 20:00 the evening before the procedure (1 sachet dissolved in 150 mL water, followed by 1.5-2 L clear liquids over 1-2 hours). The second identical dose is taken at 06:00 on the day of the capsule procedure.

Drug: Sodium Picosulfate with Magnesium Citrate (SPMC)

Interventions

Polyethylene Glycol plus Ascorbic Acid (PEG-Asc) DRUG

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.

Also known as: 1L PEG with Ascorbate

Polyethylene Glycol plus Ascorbic Acid (PEG-Asc)

Sodium Picosulfate with Magnesium Citrate (SPMC) DRUG

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.

Also known as: SPMC, Sodium Picosulfate + Mg Citrate

Sodium Picosulfate with Magnesium Citrate (SPMC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults referred for capsule colonoscopy (CC) or pan-intestinal capsule endoscopy (PCE)
• Ability to provide informed consent

You may not qualify if:

• Contraindications to capsule endoscopy (e.g., known or suspected gastrointestinal obstruction, strictures, or fistulas)
• Contraindications to the use of PEG-Asc or SPMC (e.g., severe renal impairment, congestive heart failure, electrolyte disturbances, hypersensitivity to study drugs)
• Pregnancy or lactation
• Inability to comply with the bowel preparation protocol

Sponsors & Collaborators

• Unidade Local de Saúde do Alto Ave, EPE: lead

Study Sites (1)

Unidade Local de Saúde do Alto Ave (ULSAAVE)

Guimarães, 4835-044, Portugal

Location

Related Publications (2)

• Vuik FER, Nieuwenburg SAV, Moen S, Spada C, Senore C, Hassan C, Pennazio M, Rondonotti E, Pecere S, Kuipers EJ, Spaander MCW. Colon capsule endoscopy in colorectal cancer screening: a systematic review. Endoscopy. 2021 Aug;53(8):815-824. doi: 10.1055/a-1308-1297. Epub 2021 Jan 13.

  PMID: 33440442 BACKGROUND

• Rosa B, Donato H, Curdia Goncalves T, Sousa-Pinto B, Cotter J. What Is the Optimal Bowel Preparation for Capsule Colonoscopy and Pan-intestinal Capsule Endoscopy? A Systematic Review and Meta-Analysis. Dig Dis Sci. 2023 Dec;68(12):4418-4431. doi: 10.1007/s10620-023-08133-7. Epub 2023 Oct 13.

  PMID: 37833441 BACKGROUND

MeSH Terms

Interventions

Polyethylene Glycols; Ascorbic Acid; picosulfate sodium; magnesium citrate

Intervention Hierarchy (Ancestors)

Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Hydroxy Acids; Carbohydrates

Study Officials

• José B Cotter, MD PhD

  Unidade Local de Saúde do Alto Ave

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MDPhD

Study Record Dates

• First Submitted: September 25, 2025
• First Posted: October 3, 2025
• Study Start: January 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: August 30, 2025
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: IPD and supporting documents will be available beginning 6 months after publication of the primary manuscript and for a period of 5 years thereafter.
• Access Criteria: Data will be shared through secure transfer after approval of a formal request submitted to the corresponding author.

Locations

PT (1)