The goal of this placebo-controlled randomised multicenter trial is to evaluate the efficacy and safety of anaerobic prepared donor fecal microbiota transplantation (FMT) compared to autologous FMT in patient with ulcerative colitis. Participants will receive 4 treatments with frozen FMT via both upper and lower gastro-intestinal route (infusion via duodenal tube and enemas). Donors are selected based on microbiota profile.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
85
Frozen FMT via duodenal tube (2 times) and enemas (4 times)
Amsterdam University Medical Center
Amsterdam, North Holland, Netherlands
Clinical and endoscopic remission
per adapted Mayo: stool frequency subscores (SFS) ≤ 1, rectal bleeding subscore (RBS) =0 and endoscopic subscore ≤ 1. The adapted Mayo score has a minimum score of 0 and a maximum score of 9. The 3 subscores (SFS, RBS, and endoscopic subscore) have a minimum of 0 and a maximum score of 3. The adapted Mayo score does not include PGA (physician global assessment), in contrary to the full Mayo score. A higher score reflects worse outcome.
Time frame: week 8
Clinical response
Adapted Mayo: decrease from baseline ≥ 2 points and ≥ 30% plus a decrease in RBS ≥ 1 or an absolute RBS ≤ 1. The adapted Mayo score has a minimum score of 0 and a maximum score of 9. The 3 subscores (SFS, RBS, and endoscopic subscore) have a minimum of 0 and a maximum score of 3. The adapted Mayo score does not include PGA (physician global assessment), in contrary to the full Mayo score.
Time frame: week 8
Clinical improvement
Partial adapted Mayo: a decrease from baseline ≥1 points and ≥30%, plus a decrease in RBS ≥1 or an absolute RBS ≤1. The partial adapted Mayo score has a minimum score of 0 and a maximum score of 6. The 2 subscores (SFS, RBS) have a minimum of 0 and a maximum score of 3. The partial adapted Mayo score does not include PGA (physician global assessment) and endoscopic subscore, in contrary to the full Mayo score.
Time frame: week 8
Clinical remission
Full mayo score: a decrease from baseline of ≤2 points with no subscore \>1
Time frame: week 8
Complete remission
Full Mayo score: ≤2 points reduction from baseline with no subscore \>1, and an rectal bleeding score and endoscopic subscore of 0
Time frame: week 8
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Sustained steroid-free remission
Adapted Mayo: SFS ≤1, RBS =0, endoscopic subscore ≤1, and no need for rescue therapy until week 52. The adapted Mayo score has a minimum score of 0 and a maximum score of 9. The 3 subscores (SFS, RBS, and endoscopic subscore) have a minimum of 0 and a maximum score of 3. The adapted Mayo score does not include PGA (physician global assessment), in contrary to the full Mayo score.
Time frame: week 52
Endoscopic complete remission
Proportion of patients with Endoscopic subscore = 0
Time frame: week 8
Endoscopic improvement
Proportion of patients with Endoscopic subscore of 0 or 1
Time frame: week 8
Endoscopic response, evaluated by sigmoidoscopy
•Proportion of patients with ≥1 point reduction in summed endoscopic Mayo score of both the rectum and sigmoid.
Time frame: week 8
Histological remission
Proportion of patients with Nancy Histological Index (NHI): NHI ≤1
Time frame: week 8
SCCAI
Change in SCCAI score from baseline
Time frame: week 1, 2, 3, 4, 8, 18, 39, and 52
Partial Mayo score
Change in partial mayo score from baseline. The partial Mayo score has a minimum score of 0 and a maximum score of 9. The 3 subscores (SFS, RBS, and PGA) have a minimum of 0 and a maximum score of 3. The partial Mayo score does not include endoscopic subscore, in contrary to the full Mayo score.
Time frame: week 1, 2, 3, 4, 8, 18, 39, and 52
IBD-Control
Change in IBD-Control score from baseline
Time frame: week 2, 4, 8, 18, 39, and 52
Adverse events
Occurence of adverse events
Time frame: week 8