functional bowel disease combined with intestinal bacterial overgrowth
Conditions
Interventions
FMT group:FMT therapy
Control group:Palcebo therapy
Sponsors
Department of Gastroenterology and Hepatology, the Second Hospital of Anhui Medical Univerisity
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients with chronic functional constipation or irritable bowel syndrome combined with intestinal bacterial overgrowth. 2. Aged 18-75 years, both male and female. 3. Ineffective or poorly effective for conventional treatment options. 4. Patients receive conventional treatment options for at least 4 weeks. 5. No antibiotics, prebiotics, probiotics history for at least one month. 6. At least nearly one month without colonoscopy before the history of bowel preparation, no history of diarrhea. 7. Volunteer to participate in this clinical trial and sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Women who have a pregnancy plan during pregnancy or during the trial; 2. Patients have any doubts about this technique or have other risk history; 3. The patient is at the end of the disease or may die in the study; 4. The patient's first three transplants Participate in other clinical trials; 5. Have participated in any other bacterial treatment before enrollment; 6. Hepatitis B, tuberculosis, syphilis and HIV antibody positive or any acute phase of infectious diseases; 7. Cardiac function III and above, transaminase elevation The height is more than twice the upper limit of normal, renal insufficiency (glomerular filtration rate GFR is less than 60ml / min); 8. fever temperature above 38 ° C or clinically significant active infections that can affect the test; 9 Severe anemia; severe immunodeficiency; 10. obvious cardiovascular and cerebrovascular abnormalities or according to the investigator's judgment that the patient has a heart disease that increases the risk of ventricular arrhythmia; 11. The investigator determined that the subject may influence the subject's compliance during the trial. Sex and/or conditions related to the operation of the trial-related operation, or clinical contraindications related to the pre-test; 12. Patient undergoes abdominal organ surgery three months before the fecal transplant, major organ surgery Patients under the age of 6 weeks, the patient surgical wound healing. 13. Gastrointestinal obstructive diseases, cancer patients, patients with liver and kidney dysfunction; 14. Pregnancy, lactating women or women with pregnancy intentions; 15. Suspected or indeed drug users, history of immunodeficiency; 16. Known Major active infections, or the investigator's judgment of significant blood, kidney, metabolism, gastrointestinal or endocrine dysfunction 17. Research center staff; researcher's partner or first-degree relatives; 18. Others considered by the investigator not suitable for inclusion Happening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Symptoms resolved by IBS severity score (IBS-SSS) at 8 weeks after FMT in IBS patients were more than 75 points from baseline (before FMT treatment);Hydrogen-methane respiration test for IBS patients: hydrogen negative and methane negative;Constipation patients with KESS score and constipation-related symptom self-rating scale (PAC-SYM score) improved significantly from baseline value (before FMT treatment) 8 weeks after FMT;Hydrogen-methane breath test for constipation patients: hydrogen negative and methane negative; | — |
Countries
China
Contacts
Public ContactHaiming Fang
Department of Gastroenterology and Hepatology, the Second Hospital of Anhui Medical Univerisity
Outcome results
None listed