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

Mahidol University

Status: Completed

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06850415

Si 657/2024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Experimental arm

Experimental group

Description:

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).

Treatment:

Device: Sitz-Markers

Device: Siriraj gastrointestinal transit capsule