Functional Dyspepsia
Conditions
Interventions
the intervention group (the combination of propton pump inhibitors with rifaximin):Rifaximin 1200 mg given at 400 mg three times per day for 2 weeks and standard dose propton pump inhibitors once dail
the control group (propton pump inhibitors):Standard dose propton pump inhibitors once daily for 4 weeks
Healthy control:None
Sponsors
Gastroenterology Department of Peking University Third Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria for FD Subjects: 1. Aged 18-65 years; 2. Complained of epigastric pain, epigastric burning, postprandial fullness or early satiation for over 6 months, symptoms should have been active in the past 3 months and met the Rome IV criteria. Symptoms should be severe enough to affect usual activities or to prevent finishing a regular sized meal; and no evidence of organic, systemic, or metabolic disease likely to explain these symptoms on routine investigations (including at endoscopy); one or both of the following symptoms at least 1 day per week: epigastric pain or epigastric burning; one or both of the following symptoms at least 3 days per week: postprandial fullness or early satiation. Inclusion Criteria for Healthy controls: 1. Aged 18-65 years; 2.No gastrointestinal symptoms and normal bowel movements.
Exclusion criteria
Exclusion criteria: 1. Patients who were found to have gastrointestinal organic diseases detected by endoscopy or digestive tract surgery history were excluded; 2. Patients with severe heart, liver, lung, kidney, blood, endocrine, and nervous system diseases, or severe respiratory tract, digestive tract, urinary tract infections or mental disorders will temporarily stop entering treatment until professional clinicians access their conditions; 3. Pregnant or lactating women and people who are preparing for pregnancy within the next 3 months will also be excluded; 4. Patients who were taking antibiotics, immunosuppressant or probiotics within 3 months, acid suppression drugs within 8 weeks; 5. Patients who were taking prokinetic agents more than 3 days during the past 2 weeks, non-steroidal anti-inflammatory drugs, bile acid sequestrants or bile acid sequestrants within 2 weeks will not be eligible for participation; 6. People with allergic diseases, or who were taking antihistamines, mast cell stabilizers or other antiallergic drugs will be excluded; 7. Patients or their first-degree relatives found to have a history of type 1 diabetes, celiac disease, inflammatory bowel disease, psoriasis, or other rheumatic immune system disorders will be excluded; 8. Patients with history of abdominal surgery (except for appendectomy or splenectomy) will be excluded; 9. Patients who firmly report rifaximin or rifamycin allergy will not participate, as it is possible to be randomized to the rifaximin group; 10. Patients who have a history of long-term alcohol consumption (more than 5 years, equivalent to ethanol amount >= 40 g/d, male >= 20 g/d) or heavy alcohol consumption (ethanol amount > 80 g/d) within 2 weeks will be exclude.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| symptom relief rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| the response rate;Gastrointestinal symptoms;Duodenal eosinophil counting and mucosal immune characteristics;the duodenal microbiome;the oral microbiome;the scales for emotional evaluation;negative lactulose hydrogen methane breath test;the oral microbiome; | — |
Countries
China
Contacts
Public ContactDuan Liping
Peking University Third Hospital
Outcome results
None listed