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

NCT ID: NCT06850415

Last Updated: 2025-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-30
• Study Completion Date: 2025-05-30

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Experimental arm

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).

Group Type: EXPERIMENTAL

Siriraj gastrointestinal transit capsule

Intervention Type: DEVICE

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

Sitz-Markers

Intervention Type: DEVICE

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

Interventions

Siriraj gastrointestinal transit capsule

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

Intervention Type: DEVICE

Sitz-Markers

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

Intervention Type: DEVICE

Other Intervention Names

Local made colonic capsule

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Uayporn Kaosombatwattana

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkoknoi, Bangkok, Thailand

Countries

Thailand

References

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.

Reference Type: BACKGROUND

PMID: 28738452 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31847098 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30681255 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31945360 (View on PubMed)

Other Identifiers

Si 657/2024

Identifier Type: -

Identifier Source: org_study_id