BridgeMD
Tests treatment safety and results for Irritable Bowel Syndrome With Diarrhea
Official title A Study to Evaluate the Efficacy and Safety of Live SK08 Powder in Patients With IBS-D
ClinicalTrials.gov ID: NCT06247046
What this study is testing
What is Live SK08 powder?
Live SK08 powder is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for irritable bowel syndrome with diarrhea.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 1.Voluntarily sign informed consent, be able to comply with the protocol and be able to carry out related procedures, including the completion of...
- 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...
- 4\. Colonoscopy has been completed within 12 months before the run-in period. The ileocecal part should be observed during endoscopy, and the...
- 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.
You likely can't join if
- 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...
- 3\. Parenteral diseases of the digestive system such as tuberculous peritonitis, pancreatitis, cirrhosis, and biliary tract diseases are present...
- 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...
- 6\. Previous history of abdominal and pelvic surgery, except appendectomy, caesarean section or tubal ligation without intestinal complications...
See the full eligibility criteria
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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)...
- 6\. Previous history of abdominal and pelvic surgery, except appendectomy, caesarean section or tubal ligation without intestinal complications, hernia repair.
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Wuxi, Jiangsu, China
- Binzhou, Shandong, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuxi, Jiangsu, China; Binzhou, Shandong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.