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

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.

Study Overview

• Status: Completed
• Conditions: Feasibility Studies
• Intervention / Treatment: Dietary supplement: Lactobacillus plantarum; Dietary supplement: Vitamin C

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital Clinical Trial Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lactobacillus and Vitamin C; Lactobacillus and Vitamin C supplements daily self-administration for 14 days	Dietary supplement: Lactobacillus plantarum; Lactobacillus product 1 pack daily; Dietary supplement: Vitamin C; Vitamin C tablet 1 pack daily
Placebo Comparator: Vitamin C; Vitamin C supplements daily self-administration for 14 days	Dietary supplement: Vitamin C; Vitamin C tablet 1 pack daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of spontaneous defecation	Frequency of spontaneous defecation	21 days
Formation of stool	According to Bristol Stool Scale	21 days
Other symptoms related to defecation	e.g. Excessive straining, bloating, anal obstruction, abdominal pain and discomfort, and manipulation of the fingers	21 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of days on which self-records were made among the scheduled 21 days	Feasibility assessment for DCT elements	21 days
Completeness of self-record	Feasibility assessment for DCT elements	21 days
Number of times self-records were written on the due date	Feasibility assessment for DCT elements	21 days
The proportion of completed of dosing and defecation record	Feasibility assessment for DCT elements	21 days
Proportion of the positive and negative opinions on the overall DCT procedures	Feasibility assessment for DCT elements	21 days

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): October 19, 2022
• Study Completion (Actual): December 16, 2022

Study Registration Dates

• First Submitted: August 24, 2022
• First Submitted That Met QC Criteria: August 25, 2022
• First Posted (Actual): August 29, 2022

Study Record Updates

• Last Update Posted (Actual): March 13, 2023
• Last Update Submitted That Met QC Criteria: March 9, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Vitamins; Antioxidants; Ascorbic Acid
• Other Study ID Numbers: DCT-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No