|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT03444220 |
|
Date of registration:
|
13/02/2018 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Gut Microbiota Transplantation in Systemic Sclerosis
ReSScue |
|
Scientific title:
|
Reduce Disease Activity in Systemic Sclerosis by Transplantation of an Anaerobically Cultivated Human Intestinal Microbiota, a Controlled Interventional Pilot Trial |
|
Date of first enrolment:
|
January 18, 2018 |
|
Target sample size:
|
10 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT03444220 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
|
|
Phase:
|
Phase 1/Phase 2
|
|
|
Countries of recruitment
|
|
Norway
| | | | | | | |
|
Contacts
|
|
Name:
|
Anna-Maria Hoffmann-Vold, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Oslo University Hospital |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Fulfillment of the 2013 SSc classification criteria
- Objective GI involvement and provide informed consent.
Exclusion Criteria:
- Severe organ dysfunction (and risk of procedure related complications
- Recent exposure to antibiotics
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
|
|
Health Condition(s) or Problem(s) studied
|
|
Scleroderma, Systemic
|
|
Intervention(s)
|
|
Biological: Anaerobically Cultivated medium
|
|
Biological: Anaerobically Cultivated Human Intestinal Microbiota
|
|
Primary Outcome(s)
|
|
Clinical SSc-related GI parameters
[Time Frame: The change in the UCLA GIT score from baseline to week 16 will be evaluated.]
|
|
Secondary Outcome(s)
|
|
Incidence of Treatment-Emergent Adverse Events (Safety)
[Time Frame: Explore safety of GMT intervention at each study visit (week 0, 2, 4, 8,12 and 16)]
|
|
Clinical SSc-related GI parameters
[Time Frame: The change in the UCLA GIT score from baseline will be evaluated at each study visit (week 0,2,4,8 and 12).]
|
|
Gut microbiome composition changes
[Time Frame: The investigators will assess the gut microbiome weekly from study start to week 16.]
|
|
Tissue architecture changes
[Time Frame: The investigators will analyse tissue architeure in the gut at week 0. 2 and 16. The skin tissue archtecture at week 0 and 16. The immune cell distribution in blood at week 0, 2, 4, 8, 12 and 16.]
|
|
Clinical SSc activity
[Time Frame: The investigators will assess all the SSc disease activity index measures at study start and week 16 .]
|
|
Secondary ID(s)
|
|
2016/1529
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|