Validation of New Type Radiopaque Marker in The Evaluation of Colonic Transit Time

NCT06850415 | Completed DMC

• 1 other identifier: Si 657/2024
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if the local made colonic transit capsule can be use to diagnose slow transit constipation. The main questions it aims to answer are:

• Does the local made colonic transit capsule correlate with the standard colonic capsule in the diagnosis of slow transit constipation?
• Does the number of remained radiopaque marker similar between the two test after five days of ingestion? Researchers will compare the local made colonic capsule with the standard Sitzmark colonic capsule to see the correlation. Participants will:
• Take both local made colonic capsule and Sitzmark colonic capsule at the same time.
• Obtain abdominal x-ray 5 days after capsule ingestion.
• Keep a diary of their symptoms and medication used during investigation.

Conditions

Slow Transit Constipation; Colonic Transit; Chronic Constipation; Colonic Transit Capsule; Radiopaque Marker

Keywords

Chronic constipation; Slow transit constipation; Colonic transit; Colonic transit capsule; Radiopaque marker; Diagnostic accuracy

Outcome Measures

Primary Outcomes (2)

• Correlation in the number of retained radiopaque markers from abdominal x-ray

  The correlation in the number of retained radiopaque markers in abdominal x-ray between Sitzmark colonic capsule and Siriraj gastrointestinal transit capsule.

  5 days after intervention

• Correlation in the diagnosis of slow transit constipation with radiopaque marker method

  The correlation in the diagnosis of slow transit constipation between Sitzmark colonic capsule and Siriraj gastrointestinal transit capsule defined as retained 20% or more of radiopaque marker in abdominal x-ray after 5 days of ingestion.

  5 days after intervention

Secondary Outcomes (1)

• Diagnostic performance of Siriraj gastrointesinal transit capsule

  5 days after intervention

Study Arms (1)

Experimental arm

EXPERIMENTAL

10 participants with chronic constipation according to Rome IV criteria and 10 healthy volunteers will receive 1 Sitzmark colonic capsule (contains 24 radiopaque markers) and 4 Siriraj gastrointestinal transit capsule (each contains 6 radiopaque markers).

Device: Siriraj gastrointestinal transit capsule; Device: Sitz-Markers

Interventions

Siriraj gastrointestinal transit capsule DEVICE

The Siriraj gastrointestinal transit capsule is a local made colonic transit capsule. Each capsule contains 6 circular-shaped radiopaque markers.

Also known as: Local made colonic capsule

Experimental arm

Sitz-Markers DEVICE

The standard Sitzmark colonic capsule containing 24 ring-shaped radiopaque markers.

Experimental arm

Eligibility Criteria

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

You may qualify if:

• Healthy volunteers with normal bowel habit not meet the criteria for functional constipation and irritable bowel syndrome with constipation according to Rome IV criteria
• Participants with constipation according to Rome IV criteria

You may not qualify if:

• Previous abdominal surgery
• Participants at risk for intestinal obstruction such as endometriosis, history of intra-abdominal infection
• Receive medication which affect colonic transit such as opioids
• Pregnancy

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkoknoi, Bangkok, 10700, Thailand

Location

Related Publications (4)

• Jaruvongvanich V, Patcharatrakul T, Gonlachanvit S. Prediction of Delayed Colonic Transit Using Bristol Stool Form and Stool Frequency in Eastern Constipated Patients: A Difference From the West. J Neurogastroenterol Motil. 2017 Oct 30;23(4):561-568. doi: 10.5056/jnm17022.

  PMID: 28738452 BACKGROUND

• Sharif H, Devadason D, Abrehart N, Stevenson R, Marciani L. Imaging Measurement of Whole Gut Transit Time in Paediatric and Adult Functional Gastrointestinal Disorders: A Systematic Review and Narrative Synthesis. Diagnostics (Basel). 2019 Dec 13;9(4):221. doi: 10.3390/diagnostics9040221.

  PMID: 31847098 BACKGROUND

• Bharucha AE, Anderson B, Bouchoucha M. More movement with evaluating colonic transit in humans. Neurogastroenterol Motil. 2019 Feb;31(2):e13541. doi: 10.1111/nmo.13541.

  PMID: 30681255 BACKGROUND

• Bharucha AE, Lacy BE. Mechanisms, Evaluation, and Management of Chronic Constipation. Gastroenterology. 2020 Apr;158(5):1232-1249.e3. doi: 10.1053/j.gastro.2019.12.034. Epub 2020 Jan 13.

  PMID: 31945360 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: February 27, 2025
• Study Start: March 30, 2025
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)