Coronary atherosclerosis associated irritable bowel syndrome
Conditions
Interventions
Test group:Composite probiotic intervention preparation
control group:Placebo-controlled preparation
Sponsors
Inner Mongolia Aerospace Hospital (Inner Mongolia Cardiovascular and Cerebrovascular
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1) Age >= 18 years old and = 3 times/day or = 75 and <= 300 points; 4) Previous or present diagnosis of coronary atherosclerosis; 5) Before treatment, blood routine, urine routine, stool routine+occult blood, liver and kidney function, and 12 lead ECG were all within normal range. 6)Can understand and comply with the experimental process, voluntarily participate in the experiment and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Within the 14 days prior to screening, subjects present with gastrointestinal warning symptoms such as rectal bleeding, positive fecal occult blood test, anemia, abdominal mass, ascites, fever, reduced body weight, and a family history of colorectal cancer; 2) Individuals who have been diagnosed with organic diseases of the digestive system in the past, such as inflammatory bowel disease, intestinal tuberculosis, intestinal polyps (except for polyps= half a month), intestinal diverticula, intestinal tumors, etc., or currently still have digestive ulcers, infectious diarrhea, etc; 3) Patients with previously diagnosed symptoms similar to irritable bowel syndrome, such as eosinophilic enteritis, microscopic colitis (including collagenous colitis and lymphocytic colitis), lactose intolerance, malabsorption syndrome, etc; 4) Patients with previously diagnosed non intestinal digestive system diseases, such as tuberculous peritonitis, gallstones, cirrhosis, chronic pancreatitis, etc; 5) Those who have been definitely diagnosed with diseases affecting the function of the digestive tract in the past, such as hyperthyroidism or hypothyroidism (except those who have recovered), endometriosis, chronic renal insufficiency, autoimmune diseases, diabetes, nervous (such as anorexia nervosa) or mental system diseases (such as severe depression or anxiety); 6) Previous history of digestive system surgery (excluding appendectomy and polypectomy), such as cholecystectomy; 7) Individuals with significant abnormalities in liver and kidney function (alanine aminotransferase or aspartate aminotransferase>2 times the upper limit of normal, total bilirubin>2 times the upper limit of normal, or Cr exceeding 1.5 times the upper limit of normal), hematopoietic system diseases, and tumors in the past; 8) Individuals with allergic constitution or allergies to the components of the test drug; 9) Suspect or confirm a history of alcohol or drug abuse; 10) Has received or is currently receiving treatment with any other investigational drug or device within the past 3 months; 11) Having serious mental illness or language barriers, unable to fully understand this study and sign the informed consent form; 12) Pregnant or lactating women; 13) The researchers believe that there are other situations where the subjects are not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in the total score of the Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS).; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in individual scores of each dimension of the Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS), such as abdominal pain intensity and improvement in bowel frequency/characteristics; ?; | — |
Countries
China
Contacts
Public ContactMeng Zhang
Inner Mongolia Aerospace Hospital (Inner Mongolia Cardiovascular and Cerebrovascular Hospital)
Outcome results
None listed