Tokyo, Sept. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060765) titled 'Effects of Barley Porridge Intake on Dysphagia and Gut Microbiota in Hospitalized Elderly Patients' on Sept. 1.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Placebo
Primary Sponsor:
Institute - Otsuma Women's University, Faculty of Home Economics, Department of Food Science
Condition:
Condition - Elderly with dysphagia and hospitalized elderly
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The objective is to conduct a dietary intervention using rice porridge, the staple food for elderly individuals aged 65 and older with dysphagia and hospitalized elderly patients, along with fecal analysis, to verify whether increasing dietary fiber intake can improve the disruption of the gut microbiota in hospitalized elderly patients.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - White rice porridge
Interventions/Control_2 - Waxy barley with white rice porridge
Eligibility:
Age-lower limit - 65
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Patients aged 65 years or older with a total score of 3 or higher on the Swallowing Disorder Screening Questionnaire (Nestle EAT-10), as well as patients admitted to departments such as orthopedics or cardiology (patients capable of eating for 2 to 4 weeks) will be enrolled as subjects.
Key exclusion criteria - 1) Hospitalized patients unable to consume hospital meals continuously for 2 to 4 weeks
2) Hospitalized patients for whom informed consent cannot be obtained from the patient or their authorized representative
Target Size - 20
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2020 Year 03 Month 10 Day
Date of IRB - 2020 Year 04 Month 30 Day
Anticipated trial start date - 2020 Year 07 Month 10 Day
Last follow-up date - 2026 Year 05 Month 01 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069527
Disclaimer: Curated by HT Syndication.