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AzTrials

Ulcerative ColitisPhase 2TURN2NCT05998213

Transfer of Feces in Ulcerative Colitis 2

A Phase 2 study testing Fecal microbiota transplant in people with Ulcerative Colitis and Ulcerative Colitis Flare, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
What is being tested?
Fecal microbiota transplant
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
85 participants
Where
1 siteNetherlands
Study dates
12 Jun 2020to 18 Dec 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Amsterdam University Medical Center

    Amsterdam, North Holland, 1061BK

Other trials in Netherlands

About this study

Official title: Transfer of Feces in Ulcerative Colitis 2; Improving Efficacy

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.

Being tested
Fecal microbiota transplant
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fecal microbiota transplantOther

    Also called FMT

    Frozen FMT via duodenal tube (2 times) and enemas (4 times)

Study groups in NCT05998213
Study groupRoleWhat they receive
Donor fecal microbiota transplantExperimentalNot described
Receives: Other: Fecal microbiota transplant
Autologous fecal microbiota transplantPlacebo comparatorNot described
Receives: Other: Fecal microbiota transplant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: week 8

Secondary outcomes (13)

  1. 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.

    Measured: week 8

  2. 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.

    Measured: week 8

  3. Clinical remission

    Full mayo score: a decrease from baseline of ≤2 points with no subscore >1

    Measured: week 8

  4. Complete remission

    Full Mayo score: ≤2 points reduction from baseline with no subscore >1, and an rectal bleeding score and endoscopic subscore of 0

    Measured: week 8

  5. 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.

    Measured: week 52

  6. Endoscopic complete remission

    Proportion of patients with Endoscopic subscore = 0

    Measured: week 8

  7. Endoscopic improvement

    Proportion of patients with Endoscopic subscore of 0 or 1

    Measured: week 8

  8. Endoscopic response, evaluated by sigmoidoscopy

    •Proportion of patients with ≥1 point reduction in summed endoscopic Mayo score of both the rectum and sigmoid.

    Measured: week 8

  9. Histological remission

    Proportion of patients with Nancy Histological Index (NHI): NHI ≤1

    Measured: week 8

  10. SCCAI

    Change in SCCAI score from baseline

    Measured: week 1, 2, 3, 4, 8, 18, 39, and 52

  11. 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.

    Measured: week 1, 2, 3, 4, 8, 18, 39, and 52

  12. IBD-Control

    Change in IBD-Control score from baseline

    Measured: week 2, 4, 8, 18, 39, and 52

  13. Adverse events

    Occurence of adverse events

    Measured: week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2023
  2. Study start12 Jun 2020
  3. Primary completion10 Jan 2025
  4. Study completion18 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
85 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05998213
Sponsor's protocol ID
NL65069.018.18
Acronym
TURN2
Status last verified
Mar 2026
First submitted
12 Jul 2023
Last updated
20 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Benard MV, Van Der Spek MJ, Davids M, Visser CE, Zoetendal EG, Rethans B, Zwezerijnen-Jiwa FH, Visschedijk MC, Oldenburg B, Weersma RK, Ponsioen CY. Transfer of faeces in ulcerative colitis 2: improving efficacy - study protocol for a multicentre randomised controlled trial (TURN2 study). BMJ Open. 2026 May 5;16(5):e107097. doi: 10.1136/bmjopen-2025-107097.

    PubMed 42086265

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fecal microbiota transplant in people with Ulcerative Colitis and Ulcerative Colitis Flare, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical and endoscopic remission (time frame: week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05998213, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.

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