Tokyo, July 11 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058418) titled 'Verification study on the effects of a gut health support program on constipation-related indicators' on July 10.

Study Type: Observational

Primary Sponsor: Institute - Macromill, Inc.

Condition: Condition - Healthy Adult Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To evaluate whether the continuous use of the gut health support program "Gut Note" app can alleviate issues caused by constipation. Basic objectives2 - Efficacy

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - 1)Men and women aged 20 years or older at the time of obtaining consent for participation in the study and under 65 years old at the time of study completion. 2)Individuals who experience symptoms of constipation. 3)Individuals with a bowel movement frequency of 2-5 times per week. 4)iPhone users who are capable of using a smartphone without any issues. 5)Individuals who can receive explanations and undergo examinations in a remote environment. 6)Individuals who have fully understood the purpose and content of this study and have provided consent via both the web and in writing. Key exclusion criteria - 1)Individuals undergoing any form of medical treatment at the time of trial participation. 2)Pregnant women (including those who may be pregnant) or women who are breastfeeding. 3)Individuals currently enrolled in another clinical trial as a subject, or those who have participated in another trial within four weeks after its completion. 4)Individuals who meet any of the following criteria: a) Those with diseases of the heart, liver, or kidneys (including cases involving complications from other diseases). b) Those with a history of cardiovascular diseases. c) Those diagnosed with diabetes. 5)Heavy drinkers (average pure alcohol intake of 60 g/day or more). 6)Individuals with highly irregular dietary habits. 7)Individuals engaged in shift work or night shifts, or whose lifestyle is irregular, including those who expect such changes in the near future. 8)Individuals whose lifestyle habits are likely to change during the study period. 9)Individuals who have suffered from or are currently suffering from serious intestinal diseases (such as ulcerative colitis, Crohn's disease, colorectal cancer, appendicitis, etc.). 10)Individuals using a cardiac pacemaker. 11)Any other individuals judged as unsuitable for the trial by the principal investigator. Target Size - 63

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 07 Month 09 Day Date of IRB - 2025 Year 07 Month 09 Day Anticipated trial start date - 2025 Year 07 Month 09 Day Last follow-up date - 2025 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066779

Disclaimer: Curated by HT Syndication.