JRCT ID: jRCT1062240124
Registered date:17/02/2025
Research on constipation evaluation method using bowel sounds
Basic Information
| Recruitment status | Recruiting |
|---|---|
| Health condition(s) or Problem(s) studied | chronic functional constipation |
| Date of first enrollment | 12/12/2024 |
| Target sample size | 20 |
| Countries of recruitment | |
| Study type | Interventional |
| Intervention(s) | Recording of bowel sounds at rest and after ingestion of carbonated water |
Outcome(s)
| Primary Outcome | Acoustic features of bowel sounds before and after carbonated water ingestion |
|---|---|
| Secondary Outcome | (Complete) Changes in spontaneous bowel movements, Bristol Stool Form Scale, VAS score (pain, fullness, heaviness, abdominal discomfort), constipation score (CSS), JPAC-QOL score, concomitant use of multiple drugs for constipation, type and ratio of concomitant drugs for constipation, score for each single drug for constipation and concomitant drugs comparison, presence/absence of adverse events, response rate for each background disease, endoscopic findings |
Key inclusion & exclusion criteria
| Age minimum | Not applicable |
|---|---|
| Age maximum | Not applicable |
| Gender | Both |
| Include criteria | Patients with symptoms of chronic functional constipation for at least 6 months and meeting Rome IV criteria for the last 3 months |
| Exclude criteria | Patients who have difficulty maintaining rest until bowel sounds are collected Patients with difficulty in oral intake Patients with difficulty ingesting carbonated beverages Difficulty in fasting Patients with difficulty in listening to questionnaires Patients with organic disease or drug use that causes constipation Patients who have taken drugs that promote or decrease intestinal peristalsis within 24 hours prior to the start of the study. Cases in which research consent cannot be obtained Translated with DeepL.com (free version) |
Related Information
| Primary Sponsor | Kozuka Kazuhiro |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | |
| Secondary ID(s) |
Contact
| Public contact | |
| Name | Kazuhiro Kozuka |
| Address | 1750-1 Ikenobe, Miki, Kita, Kagawa 761-0793, Japan Kagawa Japan 761-0793 |
| Telephone | +81-87-891-2156 |
| koduka2525@gmail.com | |
| Affiliation | Department of Gastroenterology and Neurology, Faculty of Medicine, Kagawa University |
| Scientific contact | |
| Name | Kazuhiro Kozuka |
| Address | 1750-1 Ikenobe, Miki, Kita, Kagawa 761-0793, Japan Kagawa Japan 761-0793 |
| Telephone | +81-87-891-2156 |
| koduka2525@gmail.com | |
| Affiliation | Department of Gastroenterology and Neurology, Faculty of Medicine, Kagawa University |