Functional gastrointestinal diseases
Conditions
Interventions
trial group:Live Bacillus licheniformis capsule (0.5g tid) and Bifidobacterium triplex capsule (0.42g bid)
control subjects:Vitamin B complex
Sponsors
Sanming First Hospital affiliated to Fujian Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.1 Inclusion criteria: 1. age 18-80 years old; 2. patients diagnosed with functional dyspepsia with anxiety and signed informed consent; 1. Diagnostic criteria for functional dyspepsia: based on the Rome IV based diagnostic criteria: (1) One or more of the following symptoms a. bothersome postprandial fullness b. bothersome early satiety c. bothersome epigastric pain d. Annoying burning sensation in the upper abdomen Simultaneous fulfilment of (2) . No evidence of structural disease that might explain symptoms (including upper gastrointestinal endoscopy) a. Criteria met within the past 3 months, with symptom onset at least 6 months prior to diagnosis b. Criteria for postprandial discomfort syndrome (PDS) and/or epigastric pain syndrome (EPS) must also be met
Exclusion criteria
Exclusion criteria: 1.2 Exclusion criteria: 1. having taken probiotics or antibiotics in the last 1 month; 2. Taking herbal medicine for a long time; 3. Those who have taken sleeping and sedative drugs and anti-anxiety and depression drugs within 1 month before admission; 4. Gastroscopic detection of organic diseases (such as gastro-oesophageal reflux, peptic ulcer, gastric cancer, etc.) and positive Helicobacter pylori infection; 5. Primary diseases or space-occupying lesions of liver, gallbladder, pancreas, spleen, etc., and other intestinal and abdominal manifestations such as biliary roundworms and typhoid fever. 6. Acute onset of disease, such as acute appendicitis, gastrointestinal perforation, intussusception, intestinal obstruction and so on; 7. Those with connective tissue diseases, renal disease, diabetes mellitus and its complications or severe organ lesions; 8. People with mental disorders, Hamilton anxiety scale score more than 29 points (with severe anxiety), combined with depressed patients (excluded by Hamilton depression scale) 9. patients with comorbid irritable bowel syndrome; 10. persons who are allergic to the study drug or are pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hamilton Anxiety Scale Scores;Upper Gastrointestinal Symptoms Scale;Determination of inflammatory mediators in serum specimens; | — |
Countries
China
Contacts
Public ContactHang Kangming
Sanming First Hospital affiliated to Fujian Medical University
Outcome results
None listed