Amsterdam University Medical Center
Amsterdam, North Holland, 1061BK, Netherlands
NCT Number: NCT05998213
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.
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Notify Me18 year–70 year
All sexes
Interventional
Phase 2
Amsterdam, North Holland, 1061BK, Netherlands
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Frozen FMT via duodenal tube (2 times) and enemas (4 times)
Other names: FMT
Time frame: week 8
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
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
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
Full mayo score: a decrease from baseline of ≤2 points with no subscore >1
Time frame: week 8
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 52
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 8
Proportion of patients with Endoscopic subscore = 0
Time frame: week 8
Proportion of patients with Endoscopic subscore of 0 or 1
Time frame: week 8
•Proportion of patients with ≥1 point reduction in summed endoscopic Mayo score of both the rectum and sigmoid.
Time frame: week 8
Proportion of patients with Nancy Histological Index (NHI): NHI ≤1
Time frame: week 1, 2, 3, 4, 8, 18, 39, and 52
Change in SCCAI score from baseline
Time frame: week 1, 2, 3, 4, 8, 18, 39, and 52
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 2, 4, 8, 18, 39, and 52
Change in IBD-Control score from baseline
Time frame: week 8
Occurence of adverse events
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Other
Transfer of Feces in Ulcerative Colitis 2; Improving Efficacy
Acronym: TURN2
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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