臨床研究等提出・公開システム

Date of registration	Aug. 01, 2024
Last modified on	Sept. 11, 2024
Trial ID	jRCT1041240066

Scientific Title	An Exploratory Study on Intake Methods of Polyethylene Glycol Formulation for Constipation Treatment Focused on Improving Palatability
Public Title	A Study on Intake Methods of Polyethylene Glycol Formulation for Constipation Treatment Focused on Improving Palatability

Contact for Scientific Queries	Name	Tatsuguchi Mariko
	Affiliation	Hamamatsu University School of Medicine
	Address	1-20-1 Handayama, Chuo-ku, Hamamatsu city, Shizuoka
	Telephone	+81-53-435-2111
	E-mail	marikot@hama-med.ac.jp
Contact for Public Queries	Name	Tatsuguchi Mariko
	Affiliation	Hamamatsu University School of Medicine
	Address	1-20-1 Handayama, Chuo-ku, Hamamatsu city, Shizuoka
	Telephone	+81-53-435-2111
	E-mail	marikot@hama-med.ac.jp

Recruitment status	Not Recruiting

Anticipated date of first enrollment		Aug. 01, 2024
Actual date of first enrollment		July. 22, 2024
Target sample size		35
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	single blind
	control	uncontrolled control
	assignment	single assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	Healthy volunteers, 18 years of age or older (both male and female)
	Exclusion Criteria	1. Volunteers with obvious taste disorders 2. Volunteers with self-reported oral abnormalities such as stomatitis 3. Volunteers with a history of allergy to the ingredients of Movicol oral powder 4. Volunteers with confirmed or suspected diseases for which Movicol oral powder is contraindicated (intestinal obstruction, intestinal perforation, severe inflammatory bowel disease such as ulcerative colitis, Crohn's disease, or toxic megacolon) 5. Volunteers who are pregnant, possibly pregnant, or breastfeeding 6. Any other volunteers deemed inappropriate by the principal investigator or co-investigators
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		palatability
Intervention(s)		The test sample (MOVICOL Combination Powder LD + organoleptic masking agents) is dissolved in 10 mL of water. The solution is held in the mouth for 10 seconds and then spit out. After spitting out, volunteers evaluate each test sample using the 100 mm visual analogue scale (VAS) by placing a mark along a 100-mm line.
Primary Outcome(s)		VAS score of overall palatability
Secondary Outcome(s)		VAS score of bitterness, VAS score of sweetness, VAS score of sourness, VAS score of saltiness, VAS score of smell and recommendation for children to take

Primary Sponsor	hamamatu university of medicine, university of shizuoka

Name of Certified Review Board	Ethics Committee of Hamamatsu University School of Medicine
Address	1-20-1 Handayama, Chuo-ku, Hamamatsu city, Shizuoka, Shizuoka
Telephone	+81-53-435-2680
E-Mail	kenkyou.s@hama-med.ac.jp
Approval Status	Approval
Date of approval	July. 17, 2024

Plan to share IPD	Yes
Plan description	After the examination, we will share the obtained questionnaires and test results among the collaborating institutions.We share electronic data with a password.

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	Sept. 11, 2024	(this page)	Changes
1	Aug. 01, 2024	Detail

List of change history