Clinical trial NCT06850415: Validation of New Type Radiopaque Marker in The Evaluation of Colonic Transit Time
Official title: Validation of New Type Radiopaque Marker in The Evaluation of Colonic Transit Time
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2025-02-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Correlation in the number of retained radiopaque markers from abdominal x-ray
timeFrame: 5 days after intervention
measure: Correlation in the diagnosis of slow transit constipation with radiopaque marker method
timeFrame: 5 days after intervention
Secondary outcomes:
measure: Diagnostic performance of Siriraj gastrointesinal transit capsule
timeFrame: 5 days after intervention
Other outcomes:
Locations:
city: Bangkoknoi
country: Thailand
facility: Faculty of Medicine Siriraj Hospital, Mahidol University
state: Bangkok
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.