Fecal Microbiota Transplant for Neuroblastoma in a Single Patient

October 31, 2025 updated by: ProgenaBiome
This study uses fecal microbiota transplant (FMT) to correct gut microbiome dysbiosis prior to and during standard-of-care neuroblastoma treatment

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Detailed Description

Patients with neurobastoma and concurrent dysbiosis showing a bifidobacteria-bacteroides gap will undergo fecal microbiota transplant as an adjunctive to standard-of-care oncology treatment.

Study Type

Expanded Access

Expanded Access Type

  • Individual Patients

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Ventura, California, United States, 93003
        • ProgenaBiome

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • willingness of parent/guardian to sign ICF
  • diagnosis of neuroblastoma
  • dysbiosis of the gut microbiome

Exclusion Criteria:

  • parent/guardian unwilling to sign ICF
  • dysbiosis does not show a bifidobaceteria-bacteroides gap
  • severely abnormal screening lab values

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ProgenaBiome

Collaborators

Microbiome Research Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

September 18, 2025

First Submitted That Met QC Criteria

October 31, 2025

First Posted (Estimated)

November 3, 2025

Study Record Updates

Last Update Posted (Estimated)

November 3, 2025

Last Update Submitted That Met QC Criteria

October 31, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IND 31935 (Other Identifier: FDA)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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