Healthy feces to treat intestinal disease in transplant patients

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN14530574

Enrollment

Registered

2018-07-23

Start date

2016-09-06

Completion date

Unknown

Last updated

2021-02-16

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

Conditions

Graft versus host disease of the intestine (GvHD) Digestive System Steroid-refractory or steroid-dependent graft vs host disease in the intestine (GvHD)

Interventions

Healthy volunteers (male and female, aged less than 60 years, Western diet) were used as donors for FMT (fecal microbiota transplantation) and received a bowel lavage with 1 litre of macrogol solution

Eligibility

Inclusion criteria

Inclusion criteria: 1. Steroid-refractory or steroid-dependent graft versus host disease of the intestine 2. Aged 18 years or older

Exclusion criteria

Exclusion criteria: 1. Unable to provide informed consent The use of immunosuppressive therapy and/or concurrent (systemic) infection does not exclude patients from participation in the study.

Design outcomes

Primary

Measure	Time frame
1. Response to treatment measured by stool frequency and volume at 7 days, 28 days, 3 months and 6 months after FMT 2. Complete response to treatment defined as complete resolution of GvHD symptoms 4 weeks after FMT. Participants were classified as CR/sf (complete responders with secondary failure) or NR (non-responders, if there was no improvement in clinical grade or follow-up time was too short to assess the effect of FMT). This is self-reported (participants keep a defecation diary) and is assessed by a physician.	—

Measure

Time frame

1. Response to treatment measured by stool frequency and volume at 7 days, 28 days, 3 months and 6 months after FMT 2. Complete response to treatment defined as complete resolution of GvHD symptoms 4 weeks after FMT. Participants were classified as CR/sf (complete responders with secondary failure) or NR (non-responders, if there was no improvement in clinical grade or follow-up time was too short to assess the effect of FMT). This is self-reported (participants keep a defecation diary) and is assessed by a physician.

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Secondary

Measure	Time frame
1. Normalisation of gut microbiome diversity, measured by 16S sequencing of microbiome diversity in stool at 1, 4, 12 and 24 weeks after FMT 2. Changes in inflammatory markers in blood and affected tissues, measured using C-reactive protein, immune subsets (T cells, B cells, innate lymphoid cells), their activation status and pro-inflammatory cytokines in the blood at 1, 4, 12 and 24 weeks after FMT. At 3 and 6 months after FMT, colon biopsies will be taken to investigate immune subsets and infiltration of inflammatory cells to this region using immunohistochemistry 3. Total number and severity of infections will be assessed using patients' medical charts 4. Total duration of hospital stays and readmissions will be assessed using patient's medical charts	—

Measure

Time frame

1. Normalisation of gut microbiome diversity, measured by 16S sequencing of microbiome diversity in stool at 1, 4, 12 and 24 weeks after FMT 2. Changes in inflammatory markers in blood and affected tissues, measured using C-reactive protein, immune subsets (T cells, B cells, innate lymphoid cells), their activation status and pro-inflammatory cytokines in the blood at 1, 4, 12 and 24 weeks after FMT. At 3 and 6 months after FMT, colon biopsies will be taken to investigate immune subsets and infiltration of inflammatory cells to this region using immunohistochemistry 3. Total number and severity of infections will be assessed using patients' medical charts 4. Total duration of hospital stays and readmissions will be assessed using patient's medical charts

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Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026