Irritable Bowel Syndrome
Conditions
Interventions
Trial Group:Basic treatment + VHProbi C08 probiotic powdered beverage: 1 sachet each time, 3 times daily (morning, afternoon, evening), dissolved in warm water (temperature not exceeding 50?)
Control Group:Basic treatment
Sponsors
Beijing University of Chinese Medicine Third Affiliated Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Age between 18 and 65 years (inclusive), regardless of gender. 2.Diagnosis of IBS according to the Rome IV criteria and the 2020 Chinese Expert Consensus Opinion on Irritable Bowel Syndrome, as follows: recurrent abdominal pain, bloating, or abdominal discomfort, with symptom onset at least 6 months prior to diagnosis, and on average at least 1 day per week in the last 3 months meeting at least two of the following points: (1) Related to defecation; (2)Associated with a change in frequency of stool; (3)Associated with a change in form (appearance) of stool. 3.IBS subtyping according to the Rome IV criteria based on at least 14 days of bowel diary. The diagnostic criteria for diarrhea-predominant IBS (IBS-D) are: more than one-quarter (25%) of stools with Bristol Stool Form Scale (BSFS) type 6 or 7 and less than one-quarter (25%) of stools with BSFS type 1 or 2. 4.Prior to enrollment, having at least 2 days per week with at least one stool of BSFS type 6 or 7 per day, and based on a daily record of the past 24 hours, meeting one of the following: the weekly average score for abdominal pain intensity (measured on a 0-10 Numeric Rating Scale, NRS) is >=3.0 points, OR the weekly average score for bloating severity is >=3.0 points, OR the weekly average score for abdominal discomfort severity is >=3.0 points. 5.The patient agrees that from the signing of the informed consent form until the final study visit, they will not make any new, significant lifestyle changes that could affect diarrheal symptoms (e.g., starting a new diet or altering their usual exercise pattern). 6. Completion of a colonoscopy within 12 months prior to enrollment, with visualization up to the cecum during endoscopy and a report containing an image record of the ileocecal valve. Subjects may be included if they meet one of the following conditions: (1)Normal colonoscopy report; (2) Abnormal colonoscopy report, such as hemorrhoids, intestinal polyps (diameter 5mm or number >3, which were endoscopically treated, with residual polyps having a diameter <=5mm and number <=3, deemed eligible for inclusion by the investigator. 7. Able to understand and comply with the requirements of the clinical trial protocol, willing to voluntarily accept the study treatment, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Individuals with a daily stool frequency >= 5 times. 2.Individuals who have undergone intestinal polyp resection within the past 1 month. 3.Any of the following findings during the screening period: (1)Renal function: serum creatinine (Scr) >= 1.5 times the upper limit of normal (ULN); (2)Liver function: aspartate aminotransferase (AST) >= 1.5 × ULN, or alanine aminotransferase (ALT) >= 1.5 × ULN, or total bilirubin >= 1.5 × ULN; (3)Abnormal stool routine results: fecal occult blood (++), red blood cells (+), or white blood cells (+); d) Significant electrocardiogram (ECG) abnormalities. 4.History of active peptic ulcer or esophagitis. 5.History of inflammatory bowel disease, intestinal tuberculosis, tuberculous peritonitis, liver cirrhosis, etc. 6.History of abdominal or pelvic surgery, except for appendectomy, cesarean section without intestinal complications, or hernia repair. 7.Use of antibiotics, digestive enzyme preparations, antimuscarinic drugs, prokinetic agents, analgesics, neurotransmitter modulators (e.g., tricyclic antidepressants), probiotic preparations (including yogurt, etc.), other microecological agents, dietary supplements, or any other medications or products affecting gastrointestinal function within one month prior to the first dose. 8.Major changes in dietary habits within one month prior to the first dose, such as initiating a high-fiber diet. 9.History of severe diseases in other organ systems, including significant pathologies of the heart, lungs, kidneys, liver, immune-mediated diseases, metabolic diseases (diabetes, thyroid disorders), malignancies, or reproductive system disorders such as ovarian cysts, endometriosis, etc. 10.History of drug or alcohol abuse. 11.Individuals planning for pregnancy (both male and female), pregnant women, or lactating women. 12.Known allergy to the investigational product or its components. 13.Individuals with convulsive symptoms or major psychiatric disorders that impair self-control and ability to cooperate. 14.Participation in any other clinical trial within 3 months prior to the first dose. 15.Illiterate individuals, or those unable to comprehend the informed consent form or sign it independently. 16.Patients deemed unsuitable by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diarrhea Severity Score ; | — |
Secondary
| Measure | Time frame |
|---|---|
| IBS-D Diarrhea Response Rate;IBS Symptom Severity Score;IBS Quality of Life Questionnaire;Record daily bowel movement frequency, stool form, and abdominal pain/bloating status. ;Mood State Score ;Anxiety and Depression Assessment;Gut Microbiota Analysis;Adverse Event/Reaction Incidence Rate; | — |
Countries
China
Contacts
Public ContactWang Zaijian
Beijing University of Chinese Medicine Third Affiliated Hospital
Outcome results
None listed