Fecal transplants for kids with severe intestinal graft-versus-host disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a pilot, multicenter, open-label study designed to assess the safety and feasibility of fecal microbiota transplantation (FMT) in patients aged 3 months to 25 years who have acute intestinal GVHD following allogeneic stem cell transplantation and steroid resistance. Participants will receive 1–3 FMTs delivered via nasojejunal tube or endoscopy. The study is prospective, non-profit, and uncontrolled, focusing on feasibility and safety signals to guide future research. Enrollment targets include those with grade II–IV intestinal GVHD without other second- or third-line therapy options. Key exclusion criteria omit active systemic infections and certain viral infections, as well as severe mucositis and chronic inflammatory bowel disease.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Diagnosis of hematological disease, malignant or non-malignant;
* Patients undergoing allogeneic stem cell transplantation from a familial or unrelated donor;
* Presence of acute GVHD with intestinal involvement (grade II-IV), steroid-resistant (i.e., with progression after 3 days of high-dose steroid therapy (methylprednisolone \> 2 mg/kg), no response after 7 days, progression during steroid tapering, or failure to achieve remission on day 28 from the start of steroid therapy), for those who have no indication for other second- or third-line therapies;
* Signed informed consent.

Exclusion Criteria:

* Presence of concurrent bacterial infections requiring systemic antibiotic therapy;
* Positivity for anti-HIV or anti-HCV antibodies, or for HbsAg with HBV-DNA positive by PCR;
* Presence of severe mucositis;
* History of chronic inflammatory bowel disease.

Where it's running

• Pediatric Hematology and Oncology, IRCCS Azienda Ospedaliero-Universitaria di Bologna
  Bologna, Italy Recruiting
• Department of Hematology/Oncology, Cell and Gene Therapy, IRCCS Bambino Gesù Children's Hospital
  Roma, Italy Recruiting
• UOC Clinica di Oncoematologia Pediatrica, Azienda Ospedale-Università Padova
  Padova, Italy Not yet recruiting

Study contacts

• Study coordinator: Pietro Merli, MD
• Email: pietro.merli@opbg.net
• Phone: +390668592623

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Moxibustion with second-line treatment for steroid-refractory acute graft-versus-host disease after transplant

  This study will test whether adding moxibustion to standard second-line drug therapy helps people aged 14–65 with steroid-refractory gastrointestinal acute GVHD after an allogeneic stem cell transplant.

  Recruiting Phase 2 Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Wuhan, Hubei · NCT07572669

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• First-line jaktinib plus corticosteroids for acute graft-versus-host disease

  This trial will test whether adding jaktinib to standard steroids helps adults with grade II–IV acute graft-versus-host disease after an allogeneic stem cell transplant.

  Recruiting Phase 1/2 First Affiliated Hospital of Zhejiang University · Hangzhou, Zhejiang · NCT07285889

• Timing of umbilical cord blood infusion and risk of acute graft-versus-host disease after transplant

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  Recruiting Phase 3 Anhui Provincial Hospital · Hefei, Anhui · NCT07047456

• Ruxolitinib treatment for acute graft-versus-host disease

  This study is testing if ruxolitinib can help people with acute graft-versus-host disease who haven't improved with regular steroid treatments.

  Recruiting at 10 sites Phase 2 Icahn School of Medicine at Mount Sinai · Duarte, California and 13 other locations · NCT06936566

• Using human chorionic gonadotropin to treat acute graft versus host disease

  This study is testing if adding a hormone called hCG to standard steroid treatment can help people with acute graft versus host disease feel better after their stem cell transplant.

  Recruiting Phase 2 Hospital Universitario Dr. Jose E. Gonzalez · Monterrey, Nuevo León · NCT06904599

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.