Fecal Transplantation in Ulcerative Colitis

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-01

Study Completion Date

2020-05-31

Brief Summary

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Adult individuals with ulcerative colitis in remission are given a single fecal microbiota transplantation (FMT) in colonoscopy. A half of the patients will receive autologous FMT as a placebo and a half will receive an FMT from a healthy donor.

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Detailed Description

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80 adult patients with ulcerative colitis (UC) will be recruited. They are randomized to receive either an autologous FMT as a placebo or FMT from a healthy donor (frozen and thawed).

The patients are followed up with fecal samples to detect microbial changes. The follow up lasts 1 year after the FMT and a follow up colonoscopy will be done 52 weeks after the FMT.

Conditions

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Ulcerative Colitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants are randomized in two groups to receive in colonoscopy either a fecal suspension made of their own feces or a fecal suspension of a healthy donor.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

The participant and the treating personnel are blinded of the randomization result.

Study Groups

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FMT

50% of the participants will receive fecal suspension of a healthy donor administered in colonoscopy into the cecum

Group Type ACTIVE_COMPARATOR

Fecal microbiota transplantation (FMT)

Intervention Type OTHER

FMT administered into the cecum of the patient in colonoscopy.

Placebo

50% of the participants will receive fecal suspension made of their own feces administered in colonoscopy into the cecum.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Autologous FMT (fecal suspension made of patients own feces) administered into the cecum of the patient in colonoscopy.

Interventions

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Fecal microbiota transplantation (FMT)

FMT administered into the cecum of the patient in colonoscopy.

Intervention Type OTHER

Placebo

Autologous FMT (fecal suspension made of patients own feces) administered into the cecum of the patient in colonoscopy.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* • • Diagnosis of CU based on clinical, endoscopic, and histological findings.

* Remission assessed by Mayo score (0 to 1) and F-Calpro (\<100 ug/g).
* Availability of consecutive fecal samples during one year after the diagnosis of CU.
* Availability of blood sample to study the IBD associated genetic background
* Compliance to attend ileocolonoscopy and FMT within 3-6 months after the diagnosis of CU and at 52 week
* 18-75 years

Exclusion Criteria

* Unable to provide informed consent
* Need for any antibiotic therapy within 3 months
* Use of corticosteroids, immunosuppressive or biological medication at the baseline
* Use of any probiotics
* Pregnancy

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No