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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON44039

Enrollment

Registered

2016-07-07

Start date

2016-07-07

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

graft versus host intestine

Interventions

fecal transplantation from healthy screened donors

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: - unable to sign informed consent

Design outcomes

Primary

Measure	Time frame
The goal and primary endpoint is reduction of GVHD (clinically and biopsy proven) in relation to a change in fecal microbiota composition at 1 and 4 weeks, 3 and 6 months after fecal transplant.	—

Secondary

Measure	Time frame
Total number and severity of infections (morbidity) , total duration of hospital stay and readmissions will be and changes in biochemical and inflammatory markers in plasma and affected tissue after fecal transplant at above mentioned time points are secondary endpoints	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)