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Transfer of Feces in Ulcerative Colitis 2 (TURN2)

Primary Purpose

Ulcerative Colitis, Ulcerative Colitis Flare, Ulcerative Colitis Acute

Status
Recruiting
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
Fecal microbiota transplant
Sponsored by
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Age ≥18 and <70 Ability to give informed consent Established ulcerative colitis with known involvement of the left colon according to the Lennard-Jones criteria Partial mayo score of ≥ 3 and calprotectin > 250 Full Mayo score 5-9 Endoscopic Mayo score of ≥2 in either the rectum or sigmoid upon screening sigmoidoscopy Stable dose of thiopurines or , 5-ASA, or budesonide in preceding 8 weeks. Stable dose of budesonide in preceding 2 weeks. Prednisone use ≤15mg/day in preceding 2 weeks with a mandatory taper of 5 mg per week starting from week 4. Women need to use reliable contraceptives during participation in the study Alkaline phosphatase > 1.5 x ULN in the subgroup of PSC/UC patients. Exclusion Criteria: Condition leading to profound immunosuppression For example: HIV, infectious diseases leading to immunosuppression, bone marrow malignancies Use of systemic chemotherapy Child-Pugh B liver cirrhosis Anti-TNFα treatment in preceding 2 months Vedolizumab treatment in preceding 2 months Tofacitinib treatment in preceding 2 months Ustekinumab treatment in preceding 2 months Cyclosporine treatment in preceding 4 weeks Use of Methotrexate in preceding 2 months Prednisolone dose > 15 mg/day in preceding 2 weeks Use of topical therapy in preceding 2 weeks Life expectancy < 12 months Difficulty with swallowing Use of systemic antibiotics in preceding 4 weeks Use of probiotic treatment in preceding 4 weeks Positive stool cultures for common enteric pathogens (Salmonella, Shigella, Yersinia, Campylobacter, enteropathogenic e coli) Positive C. Difficile stool test Positive dual faeces test for pathogenic parasites e.g. Dientamoeba histolytica, Giardia Lamblia, Dientamoeba fragilis, Blastocystis hominis only if microscopically many or very many blastocysts are seen. Positive serological test for HIV History of surgery: presence of a pouch presence of stoma Known intra-abdominal fistula Pregnancy or women who give breastfeeding Vasopressive medication, icu stay Signs of ileus, diminished passage Allergy to macrogol or substituents, eg peanuts, shellfish Known allergy to iv gadolinium in the subgroup of patients who would be scheduled for MRI liver Crohn's disease Subject who has any conditions that in the opinion of the investigator, would compromise the safety of the subject or the quality of the data and is an unsuitable candidate for the study

Sites / Locations

  • Amsterdam University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Donor fecal microbiota transplant

Autologous fecal microbiota transplant

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Endoscopic response, evaluated by sigmoidoscopy
•Proportion of patients with ≥1 point reduction in summed endoscopic Mayo score of both the rectum and sigmoid.

Full Information

First Posted
July 12, 2023
Last Updated
August 16, 2023
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators
University Medical Center Groningen, UMC Utrecht
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1. Study Identification

Unique Protocol Identification Number
NCT05998213
Brief Title
Transfer of Feces in Ulcerative Colitis 2
Acronym
TURN2
Official Title
Transfer of Feces in Ulcerative Colitis 2; Improving Efficacy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 5, 2018 (Actual)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
December 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators
University Medical Center Groningen, UMC Utrecht

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis, Ulcerative Colitis Flare, Ulcerative Colitis Acute

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Donor fecal microbiota transplant
Arm Type
Experimental
Arm Title
Autologous fecal microbiota transplant
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Fecal microbiota transplant
Other Intervention Name(s)
FMT
Intervention Description
Frozen FMT via duodenal tube (2 times) and enemas (4 times)
Primary Outcome Measure Information:
Title
Clinical and endoscopic remission
Description
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
Secondary Outcome Measure Information:
Title
Clinical response
Description
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
Title
Endoscopic response, evaluated by sigmoidoscopy
Description
•Proportion of patients with ≥1 point reduction in summed endoscopic Mayo score of both the rectum and sigmoid.
Time Frame
week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age ≥18 and <70 Ability to give informed consent Established ulcerative colitis with known involvement of the left colon according to the Lennard-Jones criteria Partial mayo score of ≥ 3 and calprotectin > 250 Full Mayo score 5-9 Endoscopic Mayo score of ≥2 in either the rectum or sigmoid upon screening sigmoidoscopy Stable dose of thiopurines or , 5-ASA, or budesonide in preceding 8 weeks. Stable dose of budesonide in preceding 2 weeks. Prednisone use ≤15mg/day in preceding 2 weeks with a mandatory taper of 5 mg per week starting from week 4. Women need to use reliable contraceptives during participation in the study Alkaline phosphatase > 1.5 x ULN in the subgroup of PSC/UC patients. Exclusion Criteria: Condition leading to profound immunosuppression For example: HIV, infectious diseases leading to immunosuppression, bone marrow malignancies Use of systemic chemotherapy Child-Pugh B liver cirrhosis Anti-TNFα treatment in preceding 2 months Vedolizumab treatment in preceding 2 months Tofacitinib treatment in preceding 2 months Ustekinumab treatment in preceding 2 months Cyclosporine treatment in preceding 4 weeks Use of Methotrexate in preceding 2 months Prednisolone dose > 15 mg/day in preceding 2 weeks Use of topical therapy in preceding 2 weeks Life expectancy < 12 months Difficulty with swallowing Use of systemic antibiotics in preceding 4 weeks Use of probiotic treatment in preceding 4 weeks Positive stool cultures for common enteric pathogens (Salmonella, Shigella, Yersinia, Campylobacter, enteropathogenic e coli) Positive C. Difficile stool test Positive dual faeces test for pathogenic parasites e.g. Dientamoeba histolytica, Giardia Lamblia, Dientamoeba fragilis, Blastocystis hominis only if microscopically many or very many blastocysts are seen. Positive serological test for HIV History of surgery: presence of a pouch presence of stoma Known intra-abdominal fistula Pregnancy or women who give breastfeeding Vasopressive medication, icu stay Signs of ileus, diminished passage Allergy to macrogol or substituents, eg peanuts, shellfish Known allergy to iv gadolinium in the subgroup of patients who would be scheduled for MRI liver Crohn's disease Subject who has any conditions that in the opinion of the investigator, would compromise the safety of the subject or the quality of the data and is an unsuitable candidate for the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cyriel Ponsioen, prof.
Phone
+31 20 5668278
Email
c.y.ponsioen@amsterdamumc.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Melanie Benard, Msc
Phone
0031645050314
Email
m.v.benard@amsterdamumc.nl
Facility Information:
Facility Name
Amsterdam University Medical Center
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1061BK
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melanie V. Bénard, Msc
Email
m.v.benard@amsterdamumc.nl
First Name & Middle Initial & Last Name & Degree
Florine Jiwa
Email
f.h.jiwa@amsterdamumc.nl
First Name & Middle Initial & Last Name & Degree
Rinse K. Weersma, Prof. dr.

12. IPD Sharing Statement

Plan to Share IPD
Yes

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Transfer of Feces in Ulcerative Colitis 2

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