About this trial
In recent years, researches illustrate that multifactorial diseases such as functional gastrointestinal disorders, autoimmune diseases, metabolic, behavioral and neurological diseases are associated with an abnormal microbiome structure-dysbiosis, which means the imbalance of the microbiome community. Fecal microbiota transplantation (FMT), the infusion of faeces from a healthy donor to the gastrointestinal tract of a recipient patient aiming to alter the intestine microbiota, is recommended to be performed in Clostridium difficile infection(CDI) as the most effective therapy. It also being used experimentally in the treatment of the disease states linked to dysbiosis of the intestinal microbiota. However, the efficacy and safety of FMT to treat the dysbiosis-associated diseases is still in its infancy. To further verify the indications above, more data is required to be collected through studies.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Irritable Bowel Syndrome
Ulcerative colitis
Crohn's disease
Constipation
Disqualifiers
Current pregnancy or breast-feeding;
Suffering from other severe diseases, including liver or kidney failure, heart failure, MODS, coma, cerebrovascular accident;
Known contraindication to all FMT infusion method such as nasoduodenal tube insertion, endoscopy, colonoscopy and enema;
Any conditions that may render the efficacy of FMT or at the discretion of the investigators.
Trial design
Parallel
Treatments tested in this trial
Fecal Microbiota Transplantation
Procedure/SurgeryProcedure: Fecal Microbiota Transplantation
Treatment groups
40
Treatment groupsSee each treatment group below.
Trial outcomes
Primary outcomes
The efficacy of FMT in patients with gastrointestinal symptom will be assessed by the change of Gastrointestinal Symptom Rating Scale(GSRS).
Gastrointestinal Symptom Rating Scale(GSRS) is a measure of gastrointestinal symptom severity in five clusters (pain, bloating, constipation, diarrhea, and early satiety).The items are scored between 1 and 7, where 1 corresponds to "no discomfort at all" and 7 to "very severe discomfort" from the symptom. The participants will be asked to filled in the scale in several time points from baseline to 12 months after FMT.
Secondary outcomes
Number of Participants With Treatment-Related Adverse Events as Assessed by Common Terminology Criteria for Adverse Events(CTCAE) V4.0
Other outcomes
Numbers of patients who have improvement in clinical symptoms (depends on each disease as stated in outcome)
Sponsors and contacts
Click on the lead sponsor to view all of their trials.