A Study on Intake Methods of Polyethylene Glycol Formulation for Constipation Treatment Focused on Improving Palatability

JRCT ID: jRCT1041240066

Registered date:01/08/2024

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: palatability
• Date of first enrollment: 22/07/2024
• Target sample size: 35
• Study type: Interventional
• 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.

Outcome(s)

• Primary Outcome: VAS score of overall palatability
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Healthy volunteers, 18 years of age or older (both male and female)

Exclude 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

Related Information

• Primary Sponsor: Tatsuguchi Mariko