Gut MicrobiotaPhase 2NCT03760133
The Change of Gut Microbiota After Bowel Preparation and the Effect of Probiotics
A Phase 2 study testing Duolac in people with Gut Microbiota and Bowel Preparation, run by Kosin University Gospel Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to investigate the relationship between the change of intestinal bacterial flora and the recovery, and the incidence of symptoms such as abdominal discomfort after colonoscopy. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Gut Microbiota, Bowel Preparation, Colonoscopy
- What is being tested?
- Duolac
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Dec 2018to 31 Dec 2019
- Phase
- Phase 2
- 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 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adults between the age of 30 and 70
Who cannot join
- subjects with cancer or IBD (inflammatory bowel disease)
- subjects with history of abdominal surgery
- subjects who take medication related to gastrointestinal motility within 3 months
- subjects who take antibiotics within 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Change of Gut Microbiota After Bowel Preparation and the Effect of Probiotics: Randomized Controlled, Open-label Trial
The purpose of this study is to investigate the relationship between the change of intestinal bacterial flora and the recovery, and the incidence of symptoms such as abdominal discomfort after colonoscopy. And the investigators will also analyze the effects of probiotics on the degree of change, recovery, and symptom development in intestinal flora.
Read the detailed description
The investigators divided two groups. (total number = 100 subjects)
- with probiotics group - 50 subjects
- Participants included in this group will be taken probiotics for 1 month after bowel preparation for colonoscopy.
- without probiotics group - 50 subjects
- Participants included in this group will not be taken probiotics for 1 month after bowel preparation for colonoscopy.
- Conditions
- Gut Microbiota, Bowel Preparation, Colonoscopy
- Being tested
- Duolac
- Keywords
- Gut microbiota, Colonoscopy, Bowel preparation, Probiotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuolacDrug
Participants included in this group will be taken probiotics for 1 month after bowel preparation for colonoscopy.
| Study group | Role | What they receive |
|---|---|---|
| with Probiotics | Active comparator | Participants included in this group will be taken probiotics for 1 month after bowel preparation for colonoscopy. Receives: Drug: Duolac |
| without Probiotics | No intervention | Participants included in this group will not be taken probiotics for 1 month after bowel preparation for colonoscopy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of probiotics on the change of gut microbiota after bowel preparation.
Analysis the change of gut microbiota before and after bowel preparation for colonoscopy, and the effect of probiotics.
Measured: eight months
Secondary outcomes (2)
The occurrence of symptoms
Analysis the occurrence of symptoms including abdominal discomfort, diarrhea, constipation or abdominal blotting after bowel preparation for colonoscopy.
Measured: eight months
The correlation between symptoms and gut microbiota..
Analysis the the correlation between the symptoms after bowel preparation for colonoscopy and the changes of gut microbiota.
Measured: eight months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2018
- Study start1 Dec 2018
- Primary completion30 Nov 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gut MicrobiotaStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kosin University Gospel Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Cell Biotech Co., Ltd.
- Responsible party
- Principal investigator, Jae Hyun Kim, Kosin University Gospel Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03760133
- Sponsor's protocol ID
- 2018-07-024
- Status last verified
- Feb 2020
- First submitted
- 25 Nov 2018
- Last updated
- 20 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators have no plan to share IPD to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Change of Gut Microbiota After Bowel Preparation and the Effect of Probiotics: Randomized Controlled, Open-label Trial
- ClinicalTrials.gov ID
- NCT03760133
- Acronym / sponsor ID
- 2018-07-024
- Conditions
- Gut Microbiota, Bowel Preparation, Colonoscopy
- Keywords
- Gut microbiota, Colonoscopy, Bowel preparation, Probiotics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Kosin University Gospel HospitalUniversity, hospital or other
- Collaborators
- Cell Biotech Co., Ltd.
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 30 Nov 2018 (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.
The purpose of this study is to investigate the relationship between the change of intestinal bacterial flora and the recovery, and the incidence of symptoms such as abdominal discomfort after colonoscopy. And the investigators will also analyze the effects of probiotics on the degree of change, recovery, and symptom development in intestinal flora.
Detailed description
The investigators divided two groups. (total number = 100 subjects)
- with probiotics group - 50 subjects
- Participants included in this group will be taken probiotics for 1 month after bowel preparation for colonoscopy.
- without probiotics group - 50 subjects
- Participants included in this group will not be taken probiotics for 1 month after bowel preparation for colonoscopy.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| with Probiotics | Active comparator | Drug: DuolacParticipants included in this group will be taken probiotics for 1 month after bowel preparation for colonoscopy. |
| without Probiotics | No intervention | –Participants included in this group will not be taken probiotics for 1 month after bowel preparation for colonoscopy. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adults between the age of 30 and 70
Key exclusion criteria (4 listed)
- subjects with cancer or IBD (inflammatory bowel disease)
- subjects with history of abdominal surgery
- subjects who take medication related to gastrointestinal motility within 3 months
- subjects who take antibiotics within 3 months
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 |
|---|---|---|
| DuolacParticipants included in this group will be taken probiotics for 1 month after bowel preparation for colonoscopy. | Drug | with Probiotics |
Primary outcome
The effect of probiotics on the change of gut microbiota after bowel preparation.
Time frame: eight months
Analysis the change of gut microbiota before and after bowel preparation for colonoscopy, and the effect of probiotics.
2 secondary outcomes
The occurrence of symptoms
Time frame: eight months
The correlation between symptoms and gut microbiota..
Time frame: eight months
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 20 Feb 2020.
- Individual participant dataSharing planned: No. The investigators have no plan to share IPD to other researchers.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Duolac in people with Gut Microbiota and Bowel Preparation, run by Kosin University Gospel 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 1 inclusion and 4 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 20 Feb 2020. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The effect of probiotics on the change of gut microbiota after bowel preparation. (time frame: eight months). 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 20 Feb 2020.