NCT01545908 is a Phase 2 clinical trial of Fecal transplant in Ulcerative Colitis, sponsored by Hamilton Health Sciences Corporation.

Who is sponsoring NCT01545908?

NCT01545908 is sponsored by Hamilton Health Sciences Corporation.

What drugs are being tested in NCT01545908?

Interventions in NCT01545908: Fecal transplant, Placebo enema.

What condition does NCT01545908 study?

NCT01545908 studies Ulcerative Colitis.

Is NCT01545908 still recruiting?

NCT01545908 is currently completed. Last updated 17 March 2015.

Last reviewed 2015-03-17 · How we verify

NCT01545908

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Randomized Controlled Trial of Fecal Biotherapy for the Induction of Remission in Active Ulcerative Colitis

Completed Phase 2 Last updated 17 March 2015

What this trial tests

Phase 2 trial testing Fecal transplant in Ulcerative Colitis in 130 participants. Completed in 1 August 2014.

Timeline

1 March 2012

Primary endpoint
1 August 2014

1 August 2014

Quick facts

Lead sponsor	Hamilton Health Sciences Corporation
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	130
Start date	1 March 2012
Primary completion	1 August 2014
Estimated completion	1 August 2014
Sites	2 locations across Canada

Drugs / interventions tested

Fecal transplant — full drug profile →
Placebo enema

Conditions studied

Ulcerative Colitis — all drugs for Ulcerative Colitis →

Sponsor

Hamilton Health Sciences Corporation — full company profile →

Who can join

18 and older, any sex, with Ulcerative Colitis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

The primary outcome of the randomized trial will remission of UC with colonic mucosa healing defined as Mayo endoscopy score = 0 at 6 weeks
Time frame: Subjects will have a sigmoidoscopy, physician assessment and complete a Mayo score and IBDQ questionnaire at baseline, week 3 (no sigmoidoscopy is required), week 6 at exit from the study.
All analyses will be conducted using both intention-to-treat and per-protocol, and the differences in remission rates and relapse rates between the two groups will be statistically analysed. The usual descriptive statistics using Fisher exact test, proportion test, rank test and t-test will be used to compare the two populations making sure that the randomization split the sample into two homogeno

Sponsor's own description

Ulcerative colitis is a condition that mainly affects young adults where the lining of the bowel is inflamed causing bloody diarrhea. The cause of ulcerative colitis is unknown and treatments remain imperfect with no cure for the disease. Initial success has been shown with a highly novel treatment where patients with active ulcerative colitis receive a fecal enema to try and replace their stool containing bacteria that may be driving their disease with that from a healthy donor. To assess if this works by comparing how well it treats the disease compared to a placebo enema.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Fecal Microbiota Transplantation Induces Remission in Patients With Active Ulcerative Colitis in a Randomized Controlled Trial.
Moayyedi P, Surette MG, Kim PT, Libertucci J, et al · · 2015 · cited 1087× · PMID 25857665 · DOI 10.1053/j.gastro.2015.04.001
Fecal transplantation for treatment of inflammatory bowel disease.
Imdad A, Nicholson MR, Tanner-Smith EE, Zackular JP, et al · · 2018 · cited 120× · PMID 30480772 · DOI 10.1002/14651858.cd012774.pub2
Assessing the efficacy and safety of fecal microbiota transplantation and probiotic VSL#3 for active ulcerative colitis: A systematic review and meta-analysis.
Dang X, Xu M, Liu D, Zhou D, et al · · 2020 · cited 56× · PMID 32182248 · DOI 10.1371/journal.pone.0228846
Gut microbiota in pathophysiology, diagnosis, and therapeutics of inflammatory bowel disease.
Pandey H, Jain D, Tang DWT, Wong SH, et al · · 2024 · cited 53× · PMID 37935653 · DOI 10.5217/ir.2023.00080
Fecal transplantation for treatment of inflammatory bowel disease.
Imdad A, Pandit NG, Zaman M, Minkoff NZ, et al · · 2023 · cited 51× · PMID 37094824 · DOI 10.1002/14651858.cd012774.pub3
Novel approaches in IBD therapy: targeting the gut microbiota-bile acid axis.
Pan Y, Zhang H, Li M, He T, et al · · 2024 · cited 39× · PMID 38769683 · DOI 10.1080/19490976.2024.2356284
Safety and efficacy of fecal microbiota transplantation for autoimmune diseases and autoinflammatory diseases: A systematic review and meta-analysis.
Zeng L, Deng Y, Yang K, Chen J, et al · · 2022 · cited 33× · PMID 36248877 · DOI 10.3389/fimmu.2022.944387
Canadian Association of Gastroenterology position statement: fecal microbiota transplant therapy.
Moayyedi P, Marshall JK, Yuan Y, Hunt R. · · 2014 · cited 26× · PMID 25232572 · DOI 10.1155/2014/346590

Verify or expand the search:

Other trials of Fecal transplant

Trials testing the same drug.

NCT03568734 — Cesarean Section and Intestinal Flora of the Newborn · NA · completed

Other recruiting trials for Ulcerative Colitis

Currently open trials in the same condition.

NCT07185009 — A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Acti · Phase 3 · recruiting
NCT07265570 — Study Evaluating ISM5411 Administered Orally to Subjects With Active Ulcerative Colitis (BETHESDA) · Phase 2 · recruiting
NCT07223424 — Patient Preference for Subcutaneous vs. Intravenous Immune Therapy · Phase 2 · recruiting
NCT06405087 — A Long-Term Extension Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis (UC) or Crohn's Disease (CD · Phase 3 · recruiting
NCT07184996 — An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Activ · Phase 3 · recruiting

Other Hamilton Health Sciences Corporation trials

Trials by the same sponsor.

NCT06567808 — Prevention of Infections in Cardiac Surgery (PICS): a Cluster-randomized Factorial Cross-over Trial · Phase 4 · not yet recruiting
NCT07118696 — Evaluating a Shorter, Rifampicin-Based Treatment for People With Less Severe Tuberculosis Disease · Phase 3 · not yet recruiting
NCT07027436 — Radiation Therapy Followed by Durvalumab (MEDI4736) and Tremelimumab And Surgery Versus Radiation Therapy Followed by Su · Phase 3 · not yet recruiting
NCT06908694 — Investigation of GLP1-Receptor Agonists in Men With Prostate Cancer Taking Androgen Deprivation Therapy · Phase 4 · recruiting
NCT06836024 — A Trial of Actazin Versus PEG 3350 for Maintenance Therapy in Children With Constipation · Phase 2, PHASE3 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01545908 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Hamilton Health Sciences Corporation
Last refreshed: 17 March 2015

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01545908.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing