Clinical trial NCT05520073: A Pilot Study To Evaluate the Effects of Lactobacillus Supplements
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Feasibility Studies
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2022-08-29
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Frequency of spontaneous defecation
timeFrame: 21 days
measure: Formation of stool
timeFrame: 21 days
measure: Other symptoms related to defecation
timeFrame: 21 days
Secondary outcomes:
Other outcomes:
measure: The number of days on which self-records were made among the scheduled 21 days
timeFrame: 21 days
measure: Completeness of self-record
timeFrame: 21 days
measure: Number of times self-records were written on the due date
timeFrame: 21 days
measure: The proportion of completed of dosing and defecation record
timeFrame: 21 days
measure: Proportion of the positive and negative opinions on the overall DCT procedures
timeFrame: 21 days
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital Clinical Trial Center
Study officials:
affiliation: Seoul National University Hospital
name: Kyung-Sang Yu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: