Fecal Microbiota Transplantation in aGvHD After ASCT

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    15
  • sponsor
    Medical University of Graz
Updated on 23 April 2022

Summary

Acute graft-versus-host-disease (aGvHD) is a typical complication after allogeneic hematopoetic stem cell transplantation (ASCT). About 30-60% of patients after ASCT are affected by aGvHD, which constitutes a relevant burden of morbidity and mortality in these patients.

Fecal microbiota transplantation (FMT) is a therapeutic concept to treat intestinal dysbiosis of various origin by infusion of the stool microbiota of a healthy donor into the gastrointestinal tract (GI) of a patient. FMT can be performed endoscopically by colonoscopic deployment of the donor microbiota into the patient´s caecum and terminal ileum.

Patients with gastrointestinal aGvHD (GI-aGvHD) are known to comprise a significant dysbiotic colonic microbiota that can be attenuated by FMT.

Details
Condition Graft Versus Host Disease in GI Tract
Treatment Fecal Microbiota Transplantation
Clinical Study IdentifierNCT03819803
SponsorMedical University of Graz
Last Modified on23 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

first episode of histologically confirmed, steroid-refractory GI-aGvHD
reduced bacterial diversity in the patient´s stool microbiota evidenced by 16s-rDNA measurement
eligibility for repeated colonoscopic procedures
informed consent

Exclusion Criteria

complications during a previous colonoscopy
recurrent episode of GI-aGvHD
lacking cardiopulmonary fitness for repeated colonoscopic procedures
septic infection
acute extraintestinal organ failure (excluding bone marrow)
mechanical ileus
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note