The safety of radio-paque markers used for colonic transit time testing

JRCT ID: jRCTs042240113

Registered date:25/10/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Chronic cconstipation
• Date of first enrollment: 14/11/2024
• Target sample size: 5
• Study type: Interventional
• Intervention(s): Use of unapproved medical device

Outcome(s)

• Primary Outcome: Incidence and severity of adverse events after the intake of radio-paque markers

Secondary Outcome

1. Visibillty of radio-peque markers
2. Distribution of radio-paque markers in the colon after 5 dyas of intake
3. Confirmation of excretion of all markwes after 4-8 weeks of intake

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 85age old
• Gender: Both

Include criteria

1. Patients with chronic constipation who are aware of constipation and are taking laxatives internally
2. Male or female patients, between 20 and 85 years of age at the time of consent
3. Patients whose written consent has been obtained prior to yje initiation of any procedure related to this study

Exclude criteria

1. Patients with suspected obstruction or stenosis of gastrointestinal tract
2. Patients with a history of abdominal or pelvic surgery
3. Patients with malignant diseases of the abdomen or pelvic area
4. Patients with a history of allergic reaction or hypersensitivity to Barium
5. Patients with dysphagia
6. Patients with infllamatory bowel disease
7. Patients who are pregnant, lactating or may be pregnant
8. Other patients who are juged by the principal investigator or sub-investigator to be inappropriate as research subjects

Related Information

• Primary Sponsor: Kamiya Takeshi
• Source(s) of Monetary Support: FUSHIMI pharmaceutical Co., Ltd.