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Transplantation of Faeces in Ulcerative Colitis; Restoring Nature's Homeostasis

NCT ID: NCT01650038

Last Updated: 2014-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2014-12-31

Brief Summary

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Ulcerative colitis (UC) is a chronic inflammatory bowel disease (IBD) of the colon. Complaints such as abdominal pain, cramps and bloody diarrhoea usually start in early adulthood and lead to life-long substantial morbidity. There is no medical treatment available that meets the desired criteria of high efficacy versus low adverse effects. The current prevailing hypothesis regarding the cause of UC states that the pathogenesis involves an inappropriate and ongoing activation of the mucosal immune system driven by the intestinal microbiota in a genetically predisposed individual. Systematic investigation into the effect of correcting the dysbiosis in ulcerative colitis patients has never been performed. The most radical way to restore the presumably disturbed natural homeostasis in UC is to perform faecal transplantation from a healthy donor. In this trial the potential beneficial effects of restoring microbial homeostasis by faecal transplantation through a duodenal tube will be studied in a phase II randomised placebo controlled design.

Endpoints are clinical remission and reduction of endoscopic inflammation after 12 weeks (primary), as well as time to recurrence, intra individual changes in faecal samples and mucosal biopsies. Follow up is 12 months.

Detailed Description

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treatment with faecal transplantation from a healthy donor in active ulcerative colitis patients. In this trial the potential beneficial effects of restoring microbial homeostasis by faecal transplantation through a duodenal tube will be studied in a phase II randomised placebo controlled design.

Conditions

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Ulcerative Colitis

Keywords

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faecal transplantation ulcerative colitis inflammatory bowel disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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faecal transplantation; donor faeces

2 times treatment with faecal transplantation: faeces from a healthy donor processed for duodenal tube infusion. after bowel lavage with macrogol.

Group Type ACTIVE_COMPARATOR

treatment with faecal transplantation (donor faeces)

Intervention Type OTHER

faecal transplantation

faecal transplantation; placebo

2 times treatment with (own) faecal transplantation: faeces from the patient processed for duodenal tube infusion. after bowel lavage with macrogol.

Group Type PLACEBO_COMPARATOR

treatment with faecal transplantation (own faeces)

Intervention Type OTHER

faecal transplantation

Interventions

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treatment with faecal transplantation (donor faeces)

faecal transplantation

Intervention Type OTHER

treatment with faecal transplantation (own faeces)

faecal transplantation

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18
* Ability to give informed consent
* Established ulcerative colitis with known involvement of the left colon according to the Lennard-Jones criteria
* SCCAI of 4 \> \< 11
* Endoscopic Mayo score of \> 1
* Stable dose of thiopurines in preceding 8 weeks
* Stable dose of corticosteroids and 5-ASA in preceding 2 weeks

Exclusion Criteria

* Condition leading to profound immunosuppression
* Anti-TNF treatment in preceding 2 months
* Cyclosporine treatment in preceding 4 weeks
* Use of Methotrexate in preceding 2 months
* Prednisolone dose \> 10 mg
* Life expectancy \< 12 months
* Use of systemic antibiotics in preceding 6 weeks
* Use of probiotic treatment in preceding 6 weeks
* Positive stool cultures for common enteric pathogens (Salmonella, Shigella, Yersinia, Campylobacter, enteropathogenic e coli)
* Positive faecal PCR-test (positive PCR means: \> 1 of the following viruses is present) for: Rotavirus, Norovirus, Enterovirus, Parechovirus Sapovirus, Adenovirus 40/41/52. Astrovirus.
* Pregnancy or women who give breastfeeding
* Vasopressive medication, icu stay
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role lead

Responsible Party

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C.Y. Ponsioen

MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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C Ponsioen, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Locations

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Academic_Medical_Center

Amsterdam, , Netherlands

Site Status

Countries

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Netherlands

References

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Rossen NG, Fuentes S, van der Spek MJ, Tijssen JG, Hartman JH, Duflou A, Lowenberg M, van den Brink GR, Mathus-Vliegen EM, de Vos WM, Zoetendal EG, D'Haens GR, Ponsioen CY. Findings From a Randomized Controlled Trial of Fecal Transplantation for Patients With Ulcerative Colitis. Gastroenterology. 2015 Jul;149(1):110-118.e4. doi: 10.1053/j.gastro.2015.03.045. Epub 2015 Mar 30.

Reference Type DERIVED
PMID: 25836986 (View on PubMed)

Other Identifiers

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METC 2011_005

Identifier Type: -

Identifier Source: org_study_id