Functional gastrointestinal disease (FGID)
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in the trial and sign the informed consent; 2. Aged between 18-65 years, gender is not limited; 3. Able to communicate well with investigators and comply with the entire trial requirements; 4. Meet FD Rome IV diagnostic criteria: disease duration of at least 6 months and one of the following diagnostic criteria for the past 3 months: postprandial fullness, early satiety at least 3 days per week (postprandial discomfort syndrome); upper and middle abdominal pain or burning sensation (at least 1 day per week); 5. FD suffers from anxiety or depression at the same time, generalized anxiety or GAD-7 score >= 5 is divided into anxiety, among them, 5-9 is divided into mild, 10-13 is divided into moderate, 14-18 is divided into moderate to severe, and 19-21 is divided into severe; depression screening scale PHQ-9 score >= 5 is divided into depression, of which 5-9 is mild, 10-14 is moderate, 15-19 is moderate-severe, and 20-27 is severe; 6. Poor response to traditional gastroenterology drugs (acid-suppressing drugs, such as proton pump inhibitors (PPI) or histamine H2 receptor antagonists, antacids, prokinetics, antispasmodics) within half a year.
Exclusion criteria
Exclusion criteria: 1. The presence of organic and metabolic diseases, including severe heart, lung, liver, kidney disease, diabetes, and connective tissue disease, has been confirmed by routine stool and occult blood test, blood biochemistry, abdominal ultrasound, gastroscope and other examinations within the past 1 year; 2. A history of abdominal and/or pelvic surgery; 3. Pregnant or lactating patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Digestive tract symptoms;Neuropsychiatric symptoms;Objective indicators of neuropsychiatric function; | — |
Countries
China
Contacts
West China Hospital, Sichuan University