Status:

COMPLETED

Gut Microbiota Transplantation in Systemic Sclerosis

Lead Sponsor:

Oslo University Hospital

Conditions:

Scleroderma, Systemic

Eligibility:

FEMALE

18+ years

Phase:

PHASE1

PHASE2

Brief Summary

Systemic Sclerosis (SSc) is a progressive multi-organ disorder with high disease burden. Life expectancy in SSc is reduced by 25-40 years, mainly due to cardiopulmonary and gastro-intestinal (GI) dise...

Detailed Description

This is a randomized, double blind clinical trial testing intervention by standardized GMT. The study cohort will include 10 SSc patients with GI symptoms. Evaluation of end points is at 16 weeks. The...

Eligibility Criteria

Inclusion

  • Fulfillment of the 2013 SSc classification criteria
  • Objective GI involvement and provide informed consent.

Exclusion

  • Severe organ dysfunction (and risk of procedure related complications
  • Recent exposure to antibiotics

Key Trial Info

Start Date :

January 18 2018

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 15 2018

Estimated Enrollment :

10 Patients enrolled

Trial Details

Trial ID

NCT03444220

Start Date

January 18 2018

End Date

October 15 2018

Last Update

March 13 2019

Active Locations (1)

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1

Oslo University Hospital

Oslo, Norway, 0372