臨床研究等提出・公開システム

Japanese

Date of registration	Feb. 17, 2025
Last modified on	Feb. 17, 2025
Trial ID	jRCT1062240124

Scientific Title	Exploratory Study on Objective Evaluation Methods for Chronic Functional Constipation Using Bowel Sounds
Public Title	Research on constipation evaluation method using bowel sounds

Contact for Scientific Queries	Name	Kozuka Kazuhiro
	Affiliation	Department of Gastroenterology and Neurology, Faculty of Medicine, Kagawa University
	Address	1750-1 Ikenobe, Miki, Kita, Kagawa 761-0793, Japan
	Telephone	+81-87-891-2156
	E-mail	koduka2525@gmail.com
Contact for Public Queries	Name	Kozuka Kazuhiro
	Affiliation	Department of Gastroenterology and Neurology, Faculty of Medicine, Kagawa University
	Address	1750-1 Ikenobe, Miki, Kita, Kagawa 761-0793, Japan
	Telephone	+81-87-891-2156
	E-mail	koduka2525@gmail.com

Recruitment status	Recruiting

Anticipated date of first enrollment		Dec. 12, 2024
Target sample size		20
Study Type		Interventional
Study Design	allocation	non-randomized controlled trial
	masking	open(masking not used)
	control	uncontrolled control
	assignment	parallel assignment
	purpose	diagnostic purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Patients with symptoms of chronic functional constipation for at least 6 months and meeting Rome IV criteria for the last 3 months
	Exclusion 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)
	Age Minimum	No limit
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		chronic functional constipation
Intervention(s)		Recording of bowel sounds at rest and after ingestion of carbonated water
Health Condition(s) Keyword		bowel sounds
Intervention(s) Keyword		bowel sounds
Health Condition(s) Code		D003248
Intervention(s) Code		D046650
Primary Outcome(s)		Acoustic features of bowel sounds before and after carbonated water ingestion
Secondary Outcome(s)		(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

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Kagawa University Faculty of Medicine Ethics Committee
Address	1750-1 Ikenobe, Miki, Kita, Kagawa 761-0793, Japan, Kagawa
Telephone	+81-87-891-2011
E-Mail	kenkyu@kagawa-u.ac.jp
Approval Status	Approval
Date of approval	Dec. 12, 2024

Plan to share IPD	Yes
Plan description	Data sharing with the University of Tokushima Graduate School of Science and Technology for Socio-Industrial Science and Technology

Countries of Recruitment（Except Japan）	none