A Study to Evaluate the Efficacy and Safety of Live SK08 Powder in Patients With IBS-D

NCT06247046 | Recruiting Phase 3

• 1 other identifier: SK08-301
• Study Type: interventional
• Target: 1,298
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Irritable Bowel Syndrome With Diarrhea

Outcome Measures

Primary Outcomes (2)

• 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.

  1-12 weeks

• Adverse events and serious adverse events

  Incidence of AE and SAE

  1-52weeks

Secondary Outcomes (11)

• Percentage of Patients Who Were Composite Weekly Responders

  1-8weeks、1-4weeks、5-8weeks、9-12weeks

• Percentage of Patients Who Were Abdominal Pain Weekly Responder

  1-12weeks、1-8weeks、1-4weeks、5-8weeks、9-12weeks

• Percentage of Patients Who Were Stool Consistency Weekly Responder

  1-12weeks、1-8weeks、1-4weeks、5-8weeks、9-12weeks

• Percentage of Patients Who Were Abdominal Bloating Weekly Responder

  1-12weeks、1-8weeks、1-4weeks、5-8weeks、9-12weeks

• Percentage of Participants Who Were Responders in IBS Symptoms Relief Scale

  1-12weeks、1-8weeks、1-4weeks、5-8weeks、9-12weeks

Study Arms (2)

Live SK08 powder

EXPERIMENTAL

Live SK08 powder, (1-25)×10\^9 CFU, oral, twice daily for up to 52 weeks period.

Drug: Live SK08 powder

Placebo

PLACEBO COMPARATOR

SK08 placebo matching powder, oral, twice daily for up to 52 weeks period.

Drug: Placebo

Interventions

Live SK08 powder DRUG

Oral Powder

Live SK08 powder

Placebo DRUG

Oral Powder

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• \. Age between 18 and 70 years old (including two-end values, based on the date of signing the Master Informed consent), regardless of gender.
• \. 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).
• \. 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.
• \. 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.
• \. 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).
• \. The patient had not used any relief drugs or analgesics in the 14 days prior to randomization.
• \. 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.

You may not qualify if:

• \. Patients with constipated, mixed and amorphous IBS.
• \. 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).
• \. 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.
• \. Known to have lactose intolerance and celiac disease.
• \. 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.
• \. Previous history of abdominal and pelvic surgery, except appendectomy, caesarean section or tubal ligation without intestinal complications, hernia repair.
• \. 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).
• \. 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.
• \. 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.
• \. 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).
• \. A history of drug or alcohol abuse.
• \. Even with the help of liquids, patients are unable to take oral solid dosage forms.
• \. Allergic to experimental drugs, rescue drugs and their ingredients.
• \. 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
• \. A woman who is pregnant or breastfeeding.

Sponsors & Collaborators

• Guangzhou Zhiyi Biotechnology Co., Ltd.: lead

Study Sites (2)

Wuxi People's Hospital

Wuxi, Jiangsu, 214023, China

RECRUITING

Binzhou Medical University Hospital

Binzhou, Shandong, 256603, China

RECRUITING

Study Officials

• Minhu Chen, Doctor

  First Affiliated Hospital, Sun Yat-Sen University

  STUDY CHAIR

• Yinglian Xiao, Doctor

  First Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yangyang Liu, Doctor

CONTACT

020-82258826; liuyangyang@zypharm.com.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicenter, Randomized, Double-blind, Placebo Controlled

Study Record Dates

• First Submitted: January 19, 2024
• First Posted: February 7, 2024
• Study Start: March 16, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)