FARAH study Fecal trAnsplantation to Reduce therapy-refractory graft versus host disease in Allogeneic Hematopoietic stem cell transplantatio

Completed

• Conditions: graft versus host; intestine; 10017990; 10027665

• Registration Number: NL-OMON44039
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 15

Inclusion Criteria

- Male and female
- > 18 years of age
- allogeneic HSCT recipients
- non critically ill
- steroid- and mesenchymal stromal therapy resistant intestinal GvHD (biopsy proven)

Exclusion Criteria

- unable to sign informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The goal and primary endpoint is reduction of GVHD (clinically and biopsy<br /><br>proven) in relation to a change in fecal microbiota composition at 1 and 4<br /><br>weeks, 3 and 6 months after fecal transplant. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Total number and severity of infections (morbidity) , total duration of<br /><br>hospital stay and readmissions will be and changes in biochemical and<br /><br>inflammatory markers in plasma and affected tissue after fecal transplant at<br /><br>above mentioned time points are secondary endpoints</p><br>