Irritable Bowel Syndrome With DiarrheaNCT05277428
Clinical Study to Evaluate the IBS Symptoms Improving Effect and Safety of GTB1
A study testing GTB1 in people with Irritable Bowel Syndrome With Diarrhea, run by Amorepacific Corporation at 1 site in South Korea.
Trial summary
This study was conducted to investigate the effects of daily supplementation of L. plantarum APsulloc 331261(GTB1TM) on improvement of IBS symptoms. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome With Diarrhea
- What is being tested?
- GTB1
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Nov 2020to 29 Jan 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female subjects older than 19 years old
- Diagnosed case of IBS using Rome IV criteria
- Who had type 6 or 7 stools according to the BSFS on at least 2 weeks ≥ 25%
- Who voluntarily agreed to participate in the study and signed an informed consent form
Who cannot join
- Who had been ingesting products containing probiotics or prebiotics in the 4 weeks preceding entry into the trial
- Who had antibiotic agents during the 4 weeks prior to study entry
- Women who is pregnant /breast-feeding, or who has childbearing potential and does not use available contraceptives
- Who is determined ineligible for study participation by investigators for any other reasons
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-design Clinical Study to Evaluate the Irritable Bowel Syndrome Symptoms Improving Effect and Safety of Lactobacillus Plantarum APsulloc 331261(GTB1)
This study was conducted to investigate the effects of daily supplementation of L. plantarum APsulloc 331261(GTB1TM) on improvement of IBS symptoms.
- Conditions
- Irritable Bowel Syndrome With Diarrhea
- Being tested
- GTB1, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GTB1Dietary supplement
2 capsule/day
PlaceboDietary supplement
2 capsule/day
| Study group | Role | What they receive |
|---|---|---|
| Lactobacillus Plantarum APsulloc 331261(GTB1) | Experimental | Take GTB1 capsule once daily for 4 weeks Receives: Dietary Supplement: GTB1 |
| Placebo | Placebo comparator | Take placebo capsule once daily for 4 weeks. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in a global relief at 4 weeks
Global relief of IBS is a dichotomous single item that asks participants "Over the past week (7 days) have you had adequate relief of your IBS symptoms?". The answer is YES or NO.
Measured: Global Relief after 4 weeks of ingestion
Changes in frequency and type of stools at 4 weeks from baseline
Number of stools per day and type of stools assessed during 7 days before the visit. Type of stools assessed using the Bristol Stool Formation Scale.
Measured: Baseline, and 4 weeks of ingestion
Changes in severity and frequency of IBS-Intestinal discomfort symptoms at 4 weeks
Intestinal discomfort symptoms are 3 symptoms that asks: abdominal pain, abdominal bloating, feeling of incomplete evacuation over the past 7 days.
Measured: Baseline, and 4 weeks of ingestion
Secondary outcomes (3)
Changes in Quality of Life at 4 weeks from baseline
Change of dissatisfaction with bowel habit and interfering with general life by Irritable Bowel Syndrome
Measured: Baseline, 1, 2 and 4 weeks of ingestion
Improvement or worsening of IBS global symptoms using Participants global impression of change scale and global improvement scale
Improvement or worsening scale 1-7
Measured: Improvement/worsening assessed after 4 weeks of ingestion
Fecal microbiome
Changes in the fecal microbiome in participants with IBS-D due to use of GTB1
Measured: Baseline, 4 weeks of ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start1 Nov 2020
- Primary completion31 Dec 2020
- Study completion29 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel Syndrome With DiarrheaStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amorepacific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jonghwa Roh, PhD, Study director, Amorepacific R&I center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05277428
- Sponsor's protocol ID
- AP-AR-2020-1
- Status last verified
- May 2022
- First submitted
- 21 Feb 2022
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Parallel-design Clinical Study to Evaluate the Irritable Bowel Syndrome Symptoms Improving Effect and Safety of Lactobacillus Plantarum APsulloc 331261(GTB1)
- ClinicalTrials.gov ID
- NCT05277428
- Acronym / sponsor ID
- AP-AR-2020-1
- Conditions
- Irritable Bowel Syndrome With Diarrhea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Amorepacific CorporationIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 29 Jan 2022 (actual)
- First posted
- 14 Mar 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 study was conducted to investigate the effects of daily supplementation of L. plantarum APsulloc 331261(GTB1TM) on improvement of IBS symptoms.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactobacillus Plantarum APsulloc 331261(GTB1) | Experimental | Dietary Supplement: GTB1Take GTB1 capsule once daily for 4 weeks |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboTake placebo capsule once daily for 4 weeks. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female subjects older than 19 years old
- Diagnosed case of IBS using Rome IV criteria
- Who had type 6 or 7 stools according to the BSFS on at least 2 weeks ≥ 25%
- Who voluntarily agreed to participate in the study and signed an informed consent form
Key exclusion criteria (4 listed)
- Who had been ingesting products containing probiotics or prebiotics in the 4 weeks preceding entry into the trial
- Who had antibiotic agents during the 4 weeks prior to study entry
- Women who is pregnant /breast-feeding, or who has childbearing potential and does not use available contraceptives
- Who is determined ineligible for study participation by investigators for any other reasons
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 |
|---|---|---|
| GTB12 capsule/day | Dietary supplement | Lactobacillus Plantarum APsulloc 331261(GTB1) |
| Placebo2 capsule/day | Dietary supplement | Placebo |
Primary outcome
Changes in a global relief at 4 weeks
Time frame: Global Relief after 4 weeks of ingestion
Global relief of IBS is a dichotomous single item that asks participants "Over the past week (7 days) have you had adequate relief of your IBS symptoms?". The answer is YES or NO.
Changes in frequency and type of stools at 4 weeks from baseline
Time frame: Baseline, and 4 weeks of ingestion
Number of stools per day and type of stools assessed during 7 days before the visit. Type of stools assessed using the Bristol Stool Formation Scale.
Changes in severity and frequency of IBS-Intestinal discomfort symptoms at 4 weeks
Time frame: Baseline, and 4 weeks of ingestion
Intestinal discomfort symptoms are 3 symptoms that asks: abdominal pain, abdominal bloating, feeling of incomplete evacuation over the past 7 days.
3 secondary outcomes
Changes in Quality of Life at 4 weeks from baseline
Time frame: Baseline, 1, 2 and 4 weeks of ingestion
Improvement or worsening of IBS global symptoms using Participants global impression of change scale and global improvement scale
Time frame: Improvement/worsening assessed after 4 weeks of ingestion
Fecal microbiome
Time frame: Baseline, 4 weeks of ingestion
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 17 May 2022.
Related trials for Irritable Bowel Syndrome With Diarrhea
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
Irritable Bowel Syndrome, Diarrhea
Active, not recruiting
The Safety And Efficacy Of A Probiotic Intervention On Lactulose Hydrogen Breath Test-Positive Patients And Related Gastrointestinal Symptoms
Small Intestinal Bacterial Overgrowth, SIBO
RecruitingPhase 2
A Study to Investigate Abdominal Symptoms With Camlipixant Compared With Placebo in Adults With Irritable Bowel Syndrome - Diarrhea (IBS-D) and Irritable Bowel Syndrome - Mixed (IBS-M)
Irritable Bowel Syndrome
Not yet recruitingPhase 2
Huanghou Zhixie Diwan in the Treatment of Irritable Bowel Syndrome With Diarrhea (IBS-D)
Patients With Irritable Bowel Syndrome With Diarrhea
Not yet recruiting
Efficacy and Mechanistic Evaluation of Hewei Anchang Formula for Overlapping Gastrointestinal Symptoms in Patients With Coexisting Functional Dyspepsia and Diarrhea-Predominant Irritable Bowel Syndrome
Functional Dyspepsia, Irritable Bowel Syndrome With Diarrhea
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.
Jonghwa Roh, PhD study director
Amorepacific R&I center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GTB1 in people with Irritable Bowel Syndrome With Diarrhea, run by Amorepacific Corporation 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 4 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 17 May 2022. 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?
Changes in a global relief at 4 weeks (time frame: Global Relief after 4 weeks of ingestion). 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 17 May 2022.