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

Not Applicable

Not yet recruiting

• Conditions: Slow Transit Constipation; Colonic Transit; Chronic Constipation; Colonic Transit Capsule; Radiopaque Marker

• Registration Number: NCT06850415
• Lead Sponsor: Mahidol University

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.

Detailed Description

The accurate diagnosis of constipation subtype is crucial especially in patients refractory to treatment. The current methods are expensive and not widely available. Thus, the investigators design the clinical study to evaluate the correlation and diagnostic accuracy of local made colonic transit capsule (Siriraj gastrointestinal transit capsule) compare with standard colonic capsule.

The patients with constipation and healthy volunteers will be enrolled. Participants will be asked to take both Sitzmark colonic capsule and Siriraj gastrointestinal transit capsule. The two capsules have different shape of radiopaque marker. The abdominal x-ray will be taken 5 days later. The number of radiopaque marker left will be counted separately between the two type of markers. Slow transit constipation is defined with retained more than 20% of radiopaque marker at 5 days after ingestion. Primary outcome is the correlation in the diagnosis of slow transit constipation and number of remained radiopaque markers between Sitzmark colonic capsule and Siriraj gastrointestinal transit capsule and the secondary outcome is the diagnostic performance of Siriraj gastrointestinal transit capsule in detecting slow transit constipation with Sitzmark colonic capsule as standard reference.

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-19
• Study First Submitted QC: 2025-02-24
• Study First Posted: 2025-02-27
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-20
• Study Start: 2025-05-21
• Primary Completion: 2025-07-01
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Correlation in the number of retained radiopaque markers from abdominal x-ray	5 days after intervention	The correlation in the number of retained radiopaque markers in abdominal x-ray between Sitzmark colonic capsule and Siriraj gastrointestinal transit capsule.
Correlation in the diagnosis of slow transit constipation with radiopaque marker method	5 days after intervention	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.

Secondary Outcome Measures

Name	Time	Method
Diagnostic performance of Siriraj gastrointesinal transit capsule	5 days after intervention	The diagnostic performance of Siriraj gastrointestinal transit capsule in the diagnosis of slow transit constipation defined as retained 20% or more of radiopaque marker in abdominal x-ray after 5 days of ingestion with Sitzmark colonic capsule as reference standard defined as sensitivity, specificity, PPV, NPV.

Trial Locations

Locations (1)

Faculty of Medicine Siriraj Hospital, Mahidol University; 🇹🇭 Bangkoknoi, Bangkok, Thailand