Ignite Creation Date:
2025-12-24 @ 1:31 PM
Ignite Modification Date:
2025-12-29 @ 10:35 AM
Study NCT ID:
NCT06333795
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-27
First Post:
2024-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Faecal Microbiota Transplantation Against Chronic Diarrhea in Patients With Systemic Sclerosis
Sponsor:
University of Aarhus
Organization:
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 1:1 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 1:1 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?: