NCT05520073

A Pilot Study To Evaluate the Effects of Lactobacillus Supplements

A Feasibility Study for Decentralized Clinical Trial: an Open-label, Randomized, Remote Clinical Trial to Evaluate the Effects of Lactobacillus Supplements on Alleviating Functional Constipation Symptoms in Poor-health Volunteers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 19 Years – 64 Years
• Healthy volunteers: Accepted

Summary

This is a feasibility study to evaluate a decentralized (remote) clinical trial in Korea. In this study, an open-label, randomized, remote clinical trial to evaluate the effects of lactobacillus supplements on alleviating functional constipation symptoms in poor-health volunteers will be conducted.

Detailed description

This study was designed for the purpose of confirming the feasibility of conducting a distributed clinical trial in the domestic medical environment and practically checking the considerations during implementation. This clinical trial aims to evaluate the effectiveness of interventions for functional constipation, a chronic disease, through the design of a fully distributed clinical trial, which is the most advanced form of distributed clinical trial. There are many patients with functional constipation around the world, and the need for a comparative randomized clinical trial for new treatments is being emphasized. It is expected to have a high potential for use in that it can be evaluated as In particular, health functional food preparations such as lactobacillus preparations have been reported to have effects on functional constipation, but it is difficult to prove their effectiveness due to the heterogeneity of clinical trial design5, so it can be considered as an application field for distributed clinical trials. For this purpose, we intend to try an exploratory clinical trial to evaluate the effectiveness of lactic acid bacteria preparations in a distributed environment. In this clinical trial, patients are recruited remotely through a website, and visits to medical institutions are minimized by delivering lactic acid bacteria to home delivery and evaluating symptom improvement through self-recording symptoms. In addition, it is intended to ensure the accuracy of the collected data by having the urine vitamin C test be performed by oneself to check whether the drug is administered or not. Through this, it is expected that issues and considerations that may arise when designing distributed clinical trials in the future can be derived.

Conditions

• Feasibility Studies

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Lactobacillus plantarum	Lactobacillus product 1 pack daily
DIETARY_SUPPLEMENT	Vitamin C	Vitamin C tablet 1 pack daily

Timeline

• Start date: 2022-09-01
• Primary completion: 2022-10-19
• Completion: 2022-12-16
• First posted: 2022-08-29
• Last updated: 2023-03-13

Locations

1 site across 1 country: South Korea