Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06333795
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-27
First Post:
2024-03-05
Brief Title:
Faecal Microbiota Transplantation Against Chronic Diarrhea in Patients With Systemic Sclerosis
Sponsor:
University of Aarhus
Organization:
University of Aarhus
Study Overview
Official Title:
Faecal Microbiota Transplantation Against Chronic Diarrhea in Patients With Systemic Sclerosis - a Randomized Double-blinded Safety and Pilot-efficacy Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FaeMiCue
Brief Summary:
This clinical trial aims to assess the safety and effectiveness of faecal Microbiota Transplantation FMT in improving chronic diarrhea symptoms among patients with systemic sclerosis
Detailed Description:
The present study aims to assess the feasibility pilot efficacy and safety of FMT for patients with Systemic Sclerosis
Participants will undergo two interventions in this present study
In the first intervention participants are randomized 11 for either active FMT or Placebo This first intervention consists of two doses of FMT with a 3-7 day gap
In the second intervention all participants receive 1 dose of active FMT treatment
This study design allows researchers to evaluate the safety of FMT in this patient group and compare the effects of FMT in the FMT-treated group vs the placebo group to see if FMT promotes remission of Chronic diarrhea Furthermore researchers will be able to gain insights into whether 2 initial doses are superior to one
Participants will undergo two interventions in this present study
In the first intervention participants are randomized 11 for either active FMT or Placebo This first intervention consists of two doses of FMT with a 3-7 day gap
In the second intervention all participants receive 1 dose of active FMT treatment
This study design allows researchers to evaluate the safety of FMT in this patient group and compare the effects of FMT in the FMT-treated group vs the placebo group to see if FMT promotes remission of Chronic diarrhea Furthermore researchers will be able to gain insights into whether 2 initial doses are superior to one
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None