A Pilot Study To Evaluate the Effects of Lactobacillus Supplements

Feasibility Studies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05520073
• Other study ID #: DCT-101
• Status: Completed
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: December 16, 2022

Study information

• Verified date: March 2023
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 16, 2022
• Est. primary completion date: October 19, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 64 Years

Eligibility

Inclusion Criteria:

• Adults aged between 19 and 64 years

• In the past 6 months, one or more of the following symptoms have been present for at least 2 weeks without having to be consecutive (based on alleviated Rome III functional constipation)

1. Excessive strain during defecation exceeds 1/4 of the total number of bowel movements

2. Lumpy or hard stool exceeds 1/4 of the total number of bowel movements

3. Feeling after defecation exceeds 1/4 of the total number of bowel movements

4. The feeling of anal obstruction during defecation exceeds 1/4 of the total number of bowel movements

5. More than 1/4 of the total number of bowel movements that require manual manipulation to help defecate

6. Less than 3 bowel movements per week

• A person who voluntarily decides to participate after hearing and fully understanding the detailed explanation of this clinical trial and consents before screening

Exclusion Criteria:

• Those who have a clinically significant hypersensitivity reaction to lactic acid bacteria, vitamin C, or ingredients included in the drug

• Persons with a history or evidence of clinically significant blood, renal, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, liver, psychiatric, neurological or immune disease (eg, colorectal cancer, etc.)

• Those who are pregnant or lactating

• Those who cannot faithfully record self-recording of dosing and defecation within the clinical trial period

• Those who are taking or expected to take lactic acid bacteria or vitamin C preparations other than health functional foods to be administered in clinical trials within the period from 2 weeks before the scheduled first dose to the last dose

• Those who judged that the investigator is inappropriate to participate in the clinical trial due to other reasons

Related Conditions & MeSH terms

• Feasibility Studies

Intervention

Dietary Supplement:
• Lactobacillus plantarum
Lactobacillus product 1 pack daily
• Vitamin C
Vitamin C tablet 1 pack daily

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital Clinical Trial Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The number of days on which self-records were made among the scheduled 21 days	Feasibility assessment for DCT elements	21 days
Other	Completeness of self-record	Feasibility assessment for DCT elements	21 days
Other	Number of times self-records were written on the due date	Feasibility assessment for DCT elements	21 days
Other	The proportion of completed of dosing and defecation record	Feasibility assessment for DCT elements	21 days
Other	Proportion of the positive and negative opinions on the overall DCT procedures	Feasibility assessment for DCT elements	21 days
Primary	Frequency of spontaneous defecation	Frequency of spontaneous defecation	21 days
Primary	Formation of stool	According to Bristol Stool Scale	21 days
Primary	Other symptoms related to defecation	e.g. Excessive straining, bloating, anal obstruction, abdominal pain and discomfort, and manipulation of the fingers	21 days