An interventional study of GTB1 and Placebo in Irritable Bowel Syndrome With Diarrhea, sponsored by Amorepacific Corporation. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-17.
Sponsored by Amorepacific Corporation · Not applicable, Interventional, and Other
This study was conducted to investigate the effects of daily supplementation of L. plantarum APsulloc 331261(GTB1TM) on improvement of IBS symptoms.
1,062 studies on the registry are indexed under Irritable Bowel Syndrome; 190 are open to participants now.
This study's enrollment of 27 is below the median of 71 across 853 interventional studies indexed under Irritable Bowel Syndrome.
Browse Irritable Bowel Syndrome studies →Amorepacific Corporation is the lead sponsor of 22 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Take GTB1 capsule once daily for 4 weeks
Dietary Supplement: GTB1
Take placebo capsule once daily for 4 weeks.
Dietary Supplement: Placebo
2 capsule/day
2 capsule/day
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, and 4 weeks of ingestion
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
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
Improvement or worsening scale 1-7
Time frame: 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
Time frame: Baseline, 4 weeks of ingestion
Changes in a global relief
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.
Time frame: Global Relief after 1, 2 and 4 weeks of ingestion
Changes in frequency and type of stools
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.
Time frame: Baseline, 1, 2 and 4 weeks of ingestion and follow-up 2 weeks
Changes in severity and frequency of IBS-Intestinal discomfort symptoms
Intestinal discomfort symptoms are 3 symptoms that asks: abdominal pain, abdominal bloating, feeling of incomplete evacuation over the past 7 days.
Time frame: Baseline, 1, 2 and 4 weeks of ingestion and follow-up 2 weeks
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Amorepacific Corporation