Irritable Bowel Syndrome
Conditions
Interventions
Experimental group:Patients with irritable bowel syndrome who were enrolled received a single microbial transplant treatment, in which 250-300ml of transplant liquid was sprayed from the rectum to the
Control group:Patients with irritable bowel syndrome who were enrolled received a single placebo treatment, in which 250-300ml of saline was sprayed from the rectum to the colon through the biopsy p
Sponsors
The First Medical Center of Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Accord with Rome IV standards:The course of disease is more than 6 months, Recurrent abdominal pain, at least one day a week, accompanied by 2 or more of the following abnormal changes in the past 3 months: (1) Abdominal pain associated with defecation; (2) Accompanied by a change in the frequency of defecation; (3) Accompanied by changes in fecal character; The main symptoms were diarrhea, constipation and abdominal pain; Lack of morphological changes and biochemical abnormalities that explain symptoms; Volunteer for fecal microbiota transplantation. Ages 18-75, male or female; Accord with the criteria for refractory IBS: an IBS—SSS score of more than 175 is considered moderate to severe, and no improvement after at least 6 months of first-line medical treatment.
Exclusion criteria
Exclusion criteria: Organic diseases were excluded by physical examination, laboratory examination, B ultrasound, endoscopy, etc.; Diarrhea or constipation caused by other diseases; A history of neuropsychiatry and alcohol abuse; Had taken sedative, antianxiety and antidepressant drugs in the last 1 month; Pregnant and lactating women; Accompanied by other systemic chronic or serious diseases, such as severe liver disease, heart disease, diabetes, etc. Other contraindications for colonoscopy and FMT.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effective rate of treatment: proportion of patients with IBS whose IBS-SSS score reduction>=50 at 3 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| IBS-SSS score of patients with IBS;Irritable bowel syndrome Quality of Life Scale, IBS-QOL;Hospital Anxiety and Depression Scale, HADS;Changes of biochemical and physiological indicators;Changes in gut microbiome structure, function, and metabolites;Adverse reactions associated with FMT were recorded and graded;Bristol stool scale score;Improvement in bowel movements; | — |
Countries
China
Contacts
Public ContactPan Fei
The First Medical Center of Chinese PLA General Hospital
Outcome results
None listed