Tokyo, Feb. 28 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060777) titled 'KMU Cranberry On Nocturnal Enuresis for Continence Trial' on Feb. 27.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Kansai Medical University
Condition:
Condition - Nocturnal enuresis
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the changes in the urinary microbiome following continuous consumption of cranberry extract supplement in children with nocturnal enuresis.
Basic objectives2 - Others
Intervention:
Interventions/Control_1 - Participants will receive cranberry extract supplement (5 tablets) once daily for 3 weeks.
Interventions/Control_2 - Participants will receive placebo (5 tablets) once daily for 3 weeks.
Eligibility:
Age-lower limit - 5
years-old
=
Gender - Male and Female
Key inclusion criteria - 1) Children aged 5 to 15 years at the time of consent.
2) Outpatients.
3) Gender: Both male and female.
4) Diagnosed with nocturnal enuresis.
5) Patients from whom written informed consent has been obtained from the participant or their legal guardian after sufficient explanation and understanding.
Key exclusion criteria - Children who meet any of the following criteria:
1) Use of antibiotics within the last month.
2) Routine consumption of cranberries or cranberry products.
3) Presence of underlying renal or urinary tract diseases.
4) Refusal to participate in this study.
5) Otherwise judged unsuitable for the study by the principal investigator.
Target Size - 50
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2026 Year 02 Month 16 Day
Date of IRB - 2026 Year 02 Month 16 Day
Anticipated trial start date - 2026 Year 02 Month 27 Day
Last follow-up date - 2029 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068873
Disclaimer: Curated by HT Syndication.