A Phase 3 interventional study of Live SK08 powder and Placebo in Irritable Bowel Syndrome With Diarrhea, sponsored by Guangzhou Zhiyi Biotechnology Co., Ltd.. Recruiting at 2 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-04-03.
Sponsored by Guangzhou Zhiyi Biotechnology Co., Ltd. · Phase 3, Interventional, and Treatment
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.
877 studies on the registry are indexed under Diarrhea; 76 are open to participants now.
This study's planned enrollment of 1,298 is above the median of 137 across 738 interventional studies indexed under Diarrhea.
Browse Diarrhea studies →Guangzhou Zhiyi Biotechnology Co., Ltd. is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live SK08 powder, (1-25)×10\^9 CFU, oral, twice daily for up to 52 weeks period.
Drug: Live SK08 powder
SK08 placebo matching powder, oral, twice daily for up to 52 weeks period.
Drug: Placebo
Oral Powder
Oral Powder
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 1-12. 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.
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
Plan to share: No
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Guangzhou Zhiyi Biotechnology Co., Ltd.