Irritable Bowel Syndrome With DiarrheaPhase 3NCT06247046
A Study to Evaluate the Efficacy and Safety of Live SK08 Powder in Patients With IBS-D
A Phase 3 study testing Live SK08 powder in people with Irritable Bowel Syndrome With Diarrhea, run by Guangzhou Zhiyi Biotechnology Co., Ltd. at 2 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Irritable Bowel Syndrome With Diarrhea
- What is being tested?
- Live SK08 powder
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,298 participants
- Where
- 2 sitesChina
- Study dates
- 16 Mar 2024to Jan 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.Voluntarily sign informed consent, be able to comply with the protocol and be able to carry out related procedures, including the completion of diary during the induction period and throughout the study period.
- 2. Age between 18 and 70 years old (including two-end values, based on the date of signing the Master Informed consent), regardless of gender.
- 3. IBS-D patients with clinical symptoms meeting the Rome IV definition, that is, the course of disease for at least 6 months, repeated abdominal pain in the past 3 months, an average of at least 1 day per week, combined with two or more of the following conditions: (1) Abdominal pain is related to defecation; ② Abdominal pain accompanied by changes in the frequency of defecation; ③ Abdominal pain accompanied by changes in fecal trait. When abnormal stool occurred in the last 3 months, the proportion of abnormal stool was >25% for Bristol fecal trait type 6 or 7, and <25% for Bristol fecal trait type 1 or 2 (see Appendix 13.3: IBS Rome IV diagnostic criteria and subtype classification criteria).
- 4. Colonoscopy has been completed within 12 months before the run-in period. The ileocecal part should be observed during endoscopy, and the ileocecal flap image recording should be included in the report. They may be included if one of the following conditions is met: (i) The colonoscopy report is normal; (ii) Abnormalities reported by colonoscopy, such as hemorrhoids and intestinal polyps (diameter ≤5mm and number ≤3), were determined by the investigator to be eligible for inclusion; (iii) Colonoscopy reported that the diameter of intestinal polyps was >5mm or the number of intestinal polyps was >3; after endoscopic treatment, the diameter of residual intestinal polyps was ≤5mm and the number of intestinal polyps was ≤3, and the investigators determined that they could be included in the group.
- 5. Colonoscopy or endoscopy should be performed at least 4 weeks before the run-in period, and IBS symptoms still occur before the run-in period.
- 6. During the run-in period, the average number of days with type 6 or type 7 fecal traits per week was ≥4 days, and the average NRS score (the highest score within 24 hours) of daily abdominal pain intensity on days with type 6 or type 7 fecal traits was ≥3.0.
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- 7. Patients completed diary at least 5 days in the week before randomization (D-7 to D-1) and at least 10 days in the 2 weeks before randomization (D-14 to D-1).
- 8. The patient had not used any relief drugs or analgesics in the 14 days prior to randomization.
- 9. During the period from the signing of the master informed consent to the end of the final study visit, patients agreed to maintain their usual diet and lifestyle, such as no changes in dietary structure or exercise patterns.
Who cannot join
- 1. Patients with constipated, mixed and amorphous IBS.
- 2. Patients with organic gastrointestinal diseases were excluded from the following conditions: superficial gastritis, grade I erosive gastritis, chronic atrophic gastritis found by endoscopy but judged by the investigator to be eligible for admission (for example, no mucosal erosion or bleeding under endoscopy, and no abdominal distension, epigastric pain, acid reflux and other symptoms).
- 3. Parenteral diseases of the digestive system such as tuberculous peritonitis, pancreatitis, cirrhosis, and biliary tract diseases are present, except for fatty liver disease that has not progressed to hepatitis, and gallstones that lack related symptoms.
- 4. Known to have lactose intolerance and celiac disease.
- 5. There are other systemic diseases, including serious diseases of the heart, lungs and kidneys, malignant tumors, autoimmune diseases, metabolic diseases (such as diabetes, diseases affecting thyroid function), reproductive system diseases (such as nonphysiologic ovarian cysts, endometriosis, severe dysmenorrhea requiring medical treatment), etc.
- 6. Previous history of abdominal and pelvic surgery, except appendectomy, caesarean section or tubal ligation without intestinal complications, hernia repair.
Show all 19Show fewer
- 7. Patients with a previously diagnosed psychiatric disorder or moderate to severe depression or generalized anxiety disorder requiring medication (PHQ-9≥10 or GAD-7≥10 during screening).
- 8. Fecal examination results showed occult blood (+) and above (except for cases caused by hemorrhoids or female menstrual periods) or white blood cells (+) and above, and were judged by the investigator to be clinically significant.
- 9. People who are positive for antibodies against hepatitis C virus (HCV), or human immunodeficiency virus (HIV), or syphilis, or hepatitis B surface antigen (HBsAg) and need antiviral therapy at the screening stage.
- 10. Laboratory tests showed significant abnormalities, and the investigator determined that the patient's participation in the study may compromise his or her safety, including but not limited to: (i) Creatinine ≥1.5 times the upper limit of normal (ULN); (ii) AST≥2 times upper limit of normal (ULN) and/or ALT≥2 times upper limit of normal (ULN) and/or total bilirubin ≥1.5 times upper limit of normal (ULN).
- 12. A history of drug or alcohol abuse.
- 13. Even with the help of liquids, patients are unable to take oral solid dosage forms.
- 14. Allergic to experimental drugs, rescue drugs and their ingredients.
- 15. During the trial, drugs that affect gastrointestinal movement and function cannot be discontinued, It includes antibiotics (such as erythromycin), drugs that regulate intestinal microecology (such as bifidobacterium), parasympathetic inhibitors (such as scopolamine, atropine, belladona, etc.), muscle relaxants (such as succinylcholine), antidiarrheal agents (such as loperamide, montmorillonite powder, etc.), opioids, drugs that inhibit gastric acid secretion, etc
- 16. A woman who is pregnant or breastfeeding.
- 17. At the time of the trial, both the patient and his partner were unable or unwilling to use reliable contraception to prevent pregnancy, or the female or male patient's partner had a recent pregnancy plan.
- 18. Have participated in any clinical trial and used the experimental drug or device within 3 months prior to signing the informed consent.
- 19. The patient had previously participated in a clinical study of SK08.
- 20.According to the judgment of the investigator, the participants are not suitable to participate in this clinical trial.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Binzhou Medical University Hospital
Binzhou, Shandong, 256603
Ning Shi, Master, shining1205@126.com
- Recruiting
Wuxi People's Hospital
Wuxi, Jiangsu, 214023
Yuhua Xu, Bachelor, 456441xyh@sina.com
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Live SK08 Powder (Bacteroidetes Fragilis) in the Treatment of Patients With Irritable Bowel Syndrome With Diarrhea (IBS-D)
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.
Read the detailed description
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.
- Conditions
- Irritable Bowel Syndrome With Diarrhea
- Being tested
- Live SK08 powder, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Live SK08 powderDrug
Oral Powder
PlaceboDrug
Oral Powder
| Study group | Role | What they receive |
|---|---|---|
| Live SK08 powder | Experimental | Live SK08 powder, (1-25)×10^9 CFU, oral, twice daily for up to 52 weeks period. Receives: Drug: Live SK08 powder |
| Placebo | Placebo comparator | SK08 placebo matching powder, oral, twice daily for up to 52 weeks period. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1-12 weeks
Adverse events and serious adverse events
Incidence of AE and SAE
Measured: 1-52weeks
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: week4、week8、week9、week12、week20、week28、week36、week44、week52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start16 Mar 2024
- Primary completionApr 2026 (estimated)
- Study completionJan 2027 (estimated)
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, Randomized, Double-blind, Placebo Controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,298 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Zhiyi Biotechnology Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Minhu Chen, Doctor, Study chair, First Affiliated Hospital, Sun Yat-Sen UniversityYinglian Xiao, Doctor, Principal investigator, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06247046
- Sponsor's protocol ID
- SK08-301
- Status last verified
- Mar 2025
- First submitted
- 19 Jan 2024
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Live SK08 Powder (Bacteroidetes Fragilis) in the Treatment of Patients With Irritable Bowel Syndrome With Diarrhea (IBS-D)
- ClinicalTrials.gov ID
- NCT06247046
- Acronym / sponsor ID
- SK08-301
- Conditions
- Irritable Bowel Syndrome With Diarrhea
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,298 participants (estimated)
- Lead sponsor
- Guangzhou Zhiyi Biotechnology Co., Ltd.University, hospital or other
- Study start
- 16 Mar 2024 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 7 Feb 2024 (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 evaluate the efficacy and safety of Live SK08 Powder compared with placebo in the treatment of participants with irritable bowel syndrome with diarrhea.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Multicenter, Randomized, Double-blind, Placebo Controlled
| Arm | Type | Receives |
|---|---|---|
| Live SK08 powder | Experimental | Drug: Live SK08 powderLive SK08 powder, (1-25)×10^9 CFU, oral, twice daily for up to 52 weeks period. |
| Placebo | Placebo comparator | Drug: PlaceboSK08 placebo matching powder, oral, twice daily for up to 52 weeks period. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 1.Voluntarily sign informed consent, be able to comply with the protocol and be able to carry out related procedures, including the completion of diary during the induction period and throughout the study period.
- 2. Age between 18 and 70 years old (including two-end values, based on the date of signing the Master Informed consent), regardless of gender.
- 3. IBS-D patients with clinical symptoms meeting the Rome IV definition, that is, the course of disease for at least 6 months, repeated abdominal pain in the past 3 months, an average of at least 1 day per week, combined with two or more of the following conditions: (1) Abdominal pain is related to defecation; ② Abdominal pain accompanied by changes in the frequency of defecation; ③ Abdominal pain accompanied by changes in fecal trait. When abnormal stool occurred in the last 3 months, the proportion of abnormal stool was >25% for Bristol fecal trait type 6 or 7, and <25% for Bristol fecal trait type 1 or 2 (see Appendix 13.3: IBS Rome IV diagnostic criteria and subtype classification criteria).
- 4. Colonoscopy has been completed within 12 months before the run-in period. The ileocecal part should be observed during endoscopy, and the ileocecal flap image recording should be included in the report. They may be included if one of the following conditions is met: (i) The colonoscopy report is normal; (ii) Abnormalities reported by colonoscopy, such as hemorrhoids and intestinal polyps (diameter ≤5mm and number ≤3), were determined by the investigator to be eligible for inclusion; (iii) Colonoscopy reported that the diameter of intestinal polyps was >5mm or the number of intestinal polyps was >3; after endoscopic treatment, the diameter of residual intestinal polyps was ≤5mm and the number of intestinal polyps was ≤3, and the investigators determined that they could be included in the group.
- 5. Colonoscopy or endoscopy should be performed at least 4 weeks before the run-in period, and IBS symptoms still occur before the run-in period.
Key exclusion criteria (19 listed)
- 1. Patients with constipated, mixed and amorphous IBS.
- 2. Patients with organic gastrointestinal diseases were excluded from the following conditions: superficial gastritis, grade I erosive gastritis, chronic atrophic gastritis found by endoscopy but judged by the investigator to be eligible for admission (for example, no mucosal erosion or bleeding under endoscopy, and no abdominal distension, epigastric pain, acid reflux and other symptoms).
- 3. Parenteral diseases of the digestive system such as tuberculous peritonitis, pancreatitis, cirrhosis, and biliary tract diseases are present, except for fatty liver disease that has not progressed to hepatitis, and gallstones that lack related symptoms.
- 4. Known to have lactose intolerance and celiac disease.
- 5. There are other systemic diseases, including serious diseases of the heart, lungs and kidneys, malignant tumors, autoimmune diseases, metabolic diseases (such as diabetes, diseases affecting thyroid function), reproductive system diseases (such as nonphysiologic ovarian cysts, endometriosis, severe dysmenorrhea requiring medical treatment), etc.
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 |
|---|---|---|
| Live SK08 powderOral Powder | Drug | Live SK08 powder |
| PlaceboOral Powder | Drug | Placebo |
Primary outcome
Percentage of Patients Who Were Composite Weekly Responders
Time frame: 1-12 weeks
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.
Adverse events and serious adverse events
Time frame: 1-52weeks
Incidence of AE and SAE
11 secondary outcomes
Percentage of Patients Who Were Composite Weekly Responders
Time frame: 1-8weeks、1-4weeks、5-8weeks、9-12weeks
Percentage of Patients Who Were Abdominal Pain Weekly Responder
Time frame: 1-12weeks、1-8weeks、1-4weeks、5-8weeks、9-12weeks
Percentage of Patients Who Were Stool Consistency Weekly Responder
Time frame: 1-12weeks、1-8weeks、1-4weeks、5-8weeks、9-12weeks
Percentage of Patients Who Were Abdominal Bloating Weekly Responder
Time frame: 1-12weeks、1-8weeks、1-4weeks、5-8weeks、9-12weeks
Percentage of Participants Who Were Responders in IBS Symptoms Relief Scale
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
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
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
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
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
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
Time frame: week4、week8、week9、week12、week20、week28、week36、week44、week52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Individual participant dataSharing planned: No
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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.
Minhu Chen, Doctor study chair
First Affiliated Hospital, Sun Yat-Sen University
Yinglian Xiao, Doctor principal investigator
First Affiliated Hospital, Sun Yat-Sen University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Live SK08 powder in people with Irritable Bowel Syndrome With Diarrhea, run by Guangzhou Zhiyi Biotechnology Co., Ltd. at 2 sites in China.
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 9 inclusion and 19 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: looking for participants now, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yangyang Liu, Doctor (020-82258826, liuyangyang@zypharm.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients Who Were Composite Weekly Responders (time frame: 1-12 weeks). The study lists 2 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 3 Apr 2025.