Feasibility StudiesNCT05520073
A Pilot Study To Evaluate the Effects of Lactobacillus Supplements
A study testing Lactobacillus plantarum and Vitamin C in people with Feasibility Studies, run by Seoul National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Feasibility Studies
- What is being tested?
- Lactobacillus plantarum and Vitamin C
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Sep 2022to 16 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
- Excessive strain during defecation exceeds 1/4 of the total number of bowel movements
- Lumpy or hard stool exceeds 1/4 of the total number of bowel movements
- Feeling after defecation exceeds 1/4 of the total number of bowel movements
- The feeling of anal obstruction during defecation exceeds 1/4 of the total number of bowel movements
Show all 9Show fewer
- More than 1/4 of the total number of bowel movements that require manual manipulation to help defecate
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital Clinical Trial Center
Seoul, 03080
About this study
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
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.
Read the 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
- Being tested
- Lactobacillus plantarum, Vitamin C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus plantarumDietary supplement
Lactobacillus product 1 pack daily
Vitamin CDietary supplement
Vitamin C tablet 1 pack daily
| Study group | Role | What they receive |
|---|---|---|
| Lactobacillus and Vitamin C | Experimental | Lactobacillus and Vitamin C supplements daily self-administration for 14 days Receives: Dietary Supplement: Lactobacillus plantarum; Dietary Supplement: Vitamin C |
| Vitamin C | Placebo comparator | Vitamin C supplements daily self-administration for 14 days Receives: Dietary Supplement: Vitamin C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of spontaneous defecation
Frequency of spontaneous defecation
Measured: 21 days
Formation of stool
According to Bristol Stool Scale
Measured: 21 days
Other symptoms related to defecation
e.g. Excessive straining, bloating, anal obstruction, abdominal pain and discomfort, and manipulation of the fingers
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start1 Sep 2022
- Primary completion19 Oct 2022
- Study completion16 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Feasibility StudiesStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyung-Sang Yu, Seoul National University Hospital
- Investigators
- Kyung-Sang Yu, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05520073
- Sponsor's protocol ID
- DCT-101
- Status last verified
- Mar 2023
- First submitted
- 24 Aug 2022
- Last updated
- 13 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05520073
- Acronym / sponsor ID
- DCT-101
- Conditions
- Feasibility Studies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 19 Oct 2022 (actual)
- Study completion
- 16 Dec 2022 (actual)
- First posted
- 29 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactobacillus and Vitamin C | Experimental | Dietary Supplement: Lactobacillus plantarum, Dietary Supplement: Vitamin CLactobacillus and Vitamin C supplements daily self-administration for 14 days |
| Vitamin C | Placebo comparator | Dietary Supplement: Vitamin CVitamin C supplements daily self-administration for 14 days |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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)
- A person who voluntarily decides to participate after hearing and fully understanding the detailed explanation of this clinical trial and consents before screening
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactobacillus plantarumLactobacillus product 1 pack daily | Dietary supplement | Lactobacillus and Vitamin C |
| Vitamin CVitamin C tablet 1 pack daily | Dietary supplement | Lactobacillus and Vitamin C, Vitamin C |
Primary outcome
Frequency of spontaneous defecation
Time frame: 21 days
Frequency of spontaneous defecation
Formation of stool
Time frame: 21 days
According to Bristol Stool Scale
Other symptoms related to defecation
Time frame: 21 days
e.g. Excessive straining, bloating, anal obstruction, abdominal pain and discomfort, and manipulation of the fingers
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyung-Sang Yu, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus plantarum and Vitamin C in people with Feasibility Studies, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of spontaneous defecation (time frame: 21 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2023.