Inflammatory Bowel Diseases
Conditions
Keywords
Inflammatory Bowel Diseases, Fecal Microbiota Transplantation, transendoscopic enteral tubing
Brief summary
No technique by placing a tube through anus into cecum for whole colon administration. This study aimed to evaluate the feasibility, safety, and efficacy of transendoscopic enteral tubing (TET) in fecal microbiota transplantation (FMT) through whole colon.
Detailed description
The previous reported fecal microbiota transplantation (FMT)through whole colon. delivering ways were involved with upper digestive tract, middle digestive tract and lower digestive tract. FMT via colonoscope is the most common approach, participants have to endure the discomfortable of bowel preparation and colonoscopy, and FMT by colonoscopy was recommended for repeat FMT treatment in short period. Traditional enema infuses bacteria solution into rectal and sigmoid colon but cannot spread to whole colon.No technique by placing a tube through anus into cecum for whole colon administration, which could be maintained for repeat FMTs.To solve these problems, investigators designed a new technique called transendoscopic enteral tubing (TET).the TET tube was fixed at cecum by clips under endoscopy. This study aimed to evaluate the feasibility, safety, and efficacy of TET for FMT via colonic approach.
Interventions
DEVICEtransendoscopic enteral tubing
Investigators designed transendoscopic enteral tubing (TET).The enteral segment of the tube is fixed in the ileocecum with distal segment fixed buttocks. The tube was used for FMT and colonic local administration
DEVICEcolonoscope
FMT via colonoscope is the most common approach.
Sponsors
Xijing Hospital of Digestive Diseases
The Second Hospital of Nanjing Medical University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
10 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Mild to moderate ulcerative colitis (Montreal classification)
Exclusion criteria
* Diagnosed as ulcerative colitis first time. * No history of using Biologic, immunomodulatory therapy or corticosteroid therapy. * With contraindication of endoscopy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| durability of clinical remission | One year | The durability of clinical remission (days) after Fecal Microbiota Transplantation procedure by TET.Defined as Montreal score S0 (clinical remission) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patients with worsened disease | one year | Number of patients with worsened disease. Increase in Montreal score S1, S2 and S3. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | one year | Number of adverse events. |
Countries
China
Contacts
Primary ContactFaming Zhang, MD,PhD
Outcome results
None listed