The purpose of this study is to evaluate the efficacy and safety of Live SK08 Powder compared with placebo in the treatment of participants with irritable bowel syndrome with diarrhea.
Irritable Bowel Syndrome (IBS) is a chronic, functional bowel disease characterized by abdominal pain, bloating, or abdominal discomfort. Symptoms may improve after bowel movements, and are often accompanied by changes in bowel habits \[frequency and/or fecal trait \]. There is a lack of organic lesions that can be detected by routine clinical examination to explain these symptoms. The pathogenesis of IBS is the result of a combination of factors, including visceral hypersensitivity, intestinal immunity and inflammation, gastrointestinal motility abnormalities, and intestinal flora. SK08 can relieve abdominal pain and diarrhea by protecting intestinal barrier function, regulating immunity (such as reducing inflammatory factors TNF-α etc., promoting macrophages to phagocytosis of pathogenic bacteria), and correcting bacterial imbalance, to achieve the therapeutic effect.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,298
Oral Powder
Oral Powder
Wuxi People's Hospital
Wuxi, Jiangsu, China
RECRUITINGBinzhou Medical University Hospital
Binzhou, Shandong, China
RECRUITINGPercentage of Patients Who Were Composite Weekly Responders
A patient is categorized as a composite weekly responder if the patient achieved the prespecified response displayed in the following for at least 50% of the weeks during the interval from weeks 1-12. Abdominal pain response: a decrease in the weekly average of worst abdominal pain (as measured by the 11-point NRS-scale) in the past 24 hours score of at least 30% compared with baseline. Stool consistency response: a 50% or greater reduction in the number of days per week with at least one stool that has a consistency of Type 6 or 7 (as measured by the Bristol Stool Form Scale) compared with baseline.
Time frame: 1-12 weeks
Adverse events and serious adverse events
Incidence of AE and SAE
Time frame: 1-52weeks
Percentage of Patients Who Were Composite Weekly Responders
A patient is categorized as a composite weekly responder if the patient achieved the prespecified response displayed in the following for at least 50% of the weeks during the interval from weeks 1-8、weeks 1-4、weeks 5-8 or weeks 9-12. Abdominal pain response: a decrease in the weekly average of worst abdominal pain (as measured by the 11-point NRS-scale) in the past 24 hours score of at least 30% compared with baseline. Stool consistency response: a 50% or greater reduction in the number of days per week with at least one stool that has a consistency of Type 6 or 7 (as measured by the Bristol Stool Form Scale) compared with baseline.
Time frame: 1-8weeks、1-4weeks、5-8weeks、9-12weeks
Percentage of Patients Who Were Abdominal Pain Weekly Responder
A patient is categorized as an abdominal pain weekly responder if the patient achieved prespecified response, i.e. a decrease in the weekly average of worst abdominal pain (as measured by the 11-point NRS-scale) in the past 24 hours score of at least 30% compared with baseline on at least 50% of weeks during the interval from weeks 1-12、weeks 1-8、weeks 1-4、weeks 5-8 or weeks 9-12.
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Time frame: 1-12weeks、1-8weeks、1-4weeks、5-8weeks、9-12weeks
Percentage of Patients Who Were Stool Consistency Weekly Responder
A patient is categorized as an stool consistency weekly responder if the patient achieved prespecified response, i.e. a 50% or greater reduction in the number of days per week with at least one stool that has a consistency of Type 6 or 7 (as measured by the Bristol Stool Form Scale) compared with baseline on at least 50% of weeks during the interval from weeks 1-12、weeks 1-8、weeks 1-4、weeks 5-8 or weeks 9-12.
Time frame: 1-12weeks、1-8weeks、1-4weeks、5-8weeks、9-12weeks
Percentage of Patients Who Were Abdominal Bloating Weekly Responder
A patient is categorized as an abdominal bloating weekly responder if the patient achieved prespecified response, i.e. a decrease in the weekly average of worst abdominal bloating (as measured by the 11-point NRS-scale) in the past 24 hours score of at least 30% compared with baseline on at least 50% of weeks during the interval from weeks 1-12、weeks 1-8、weeks 1-4、weeks 5-8 or weeks 9-12.
Time frame: 1-12weeks、1-8weeks、1-4weeks、5-8weeks、9-12weeks
Percentage of Participants Who Were Responders in IBS Symptoms Relief Scale
Relief of IBS symptoms was assessed once weekly by patients answering the IBS Symptoms Relief Scale in the electronic diary. Responders were defined as patients with a weekly response of "Yes" to relief of their IBS symptoms for at least 50% of weeks during the interval from weeks 1-12、weeks 1-8、weeks 1-4、weeks 5-8 or weeks 9-12.
Time frame: 1-12weeks、1-8weeks、1-4weeks、5-8weeks、9-12weeks
Change from Baseline in the Weekly Average of Worst Abdominal Pain in the Past 24 hours
Symptoms of abdominal pain were measured by the 11-point NRS-scale, where 0 corresponded to no abdominal pain and 10 corresponded to worst imaginable abdominal pain. A negative change from Baseline indicates the abdominal pain decreased.
Time frame: week1、week2、week3、week4、week5、week6、week7、week8、week9、week10、week11、week12.
Change from Baseline in the Number of Days per Week with at Least One Stool with Consistency of Type 6 or 7
Patients recorded the number of days per week with at least one stool with consistency of Type 6 or 7 during weeks 1-12. Stool consistency was measured by the Bristol Stool Form Scale.
Time frame: week1、week2、week3、week4、week5、week6、week7、week8、week9、week10、week11、week12.
Change from Baseline in the Number of Stools of Type 6 or 7 per Week
Patients recorded the number of stools of Type 6 or 7 every day during weeks 1-12. Stool consistency was measured by the Bristol Stool Form Scale.
Time frame: week1、week2、week3、week4、week5、week6、week7、week8、week9、week10、week11、week12.
Change from Baseline in the Weekly Average of Worst Abdominal Bloating in the Past 24 Hours Score
Symptoms of abdominal bloating were measured by the 11-point NRS-scale, where 0 corresponded to no abdominal bloating and 10 corresponded to worst imaginable abdominal bloating. A negative change from Baseline indicates the abdominal bloating decreased.
Time frame: week1、week2、week3、week4、week5、week6、week7、week8、week9、week10、week11、week12.
Change from baseline in Irritable Bowel Syndrome Severity Scale (IBS-SSS) Scores
The IBS Symptom Severity Score is produced from 5 symptom responses on the questionnaire, the total score with a possible range of scores from 0 to 500. A negative change from Baseline indicates that IBS symptom severity improved.
Time frame: week4、week8、week9、week12、week20、week28、week36、week44、week52
Change from baseline in Irritable Bowel Syndrome Quality of Life Scale (IBS-QoL) Total Scores
The IBS-QoL consists of 34 items each with a 5-point response scale, where 1 generally represents better responses on items and 5 represents worse responses. The individual responses to the answered items were summed and standardized for a total score and then transformed to a 0- to 100- point scale (0=worst; 100=better) for ease of interpretation. A positive change from Baseline indicates that quality of life improved.
Time frame: week4、week8、week9、week12、week20、week28、week36、week44、week52