NeuroblastomaNCT07223606
Fecal Microbiota Transplant for Neuroblastoma in a Single Patient
A study testing Fecal Microbial Transplantation in people with Neuroblastoma and Neuroblastoma (NB), run by ProgenaBiome at 1 site in United States.
Trial summary
This study uses fecal microbiota transplant (FMT) to correct gut microbiome dysbiosis prior to and during standard-of-care neuroblastoma treatment Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Neuroblastoma, Neuroblastoma (NB), Neuroblastoma (NBL)
- What is being tested?
- Fecal Microbial Transplantation
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- willingness of parent/guardian to sign ICF
- diagnosis of neuroblastoma
- dysbiosis of the gut microbiome
Who cannot join
- parent/guardian unwilling to sign ICF
- dysbiosis does not show a bifidobaceteria-bacteroides gap
- severely abnormal screening lab values
Trial locations and contacts
1 site in 1 country.
About this study
This study uses fecal microbiota transplant (FMT) to correct gut microbiome dysbiosis prior to and during standard-of-care neuroblastoma treatment
Read the 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.
- Conditions
- Neuroblastoma, Neuroblastoma (NB), Neuroblastoma (NBL), Neuroblastoma (Measurable Disease), Neuroblastoma Recurrent, Neuroblastoma in Children
- Being tested
- Fecal Microbial Transplantation
- Keywords
- FMT, fecal transplant, fecal microbiota transplant, microbiome, dysbiosis
- Medical subject headings
- Neuroblastoma, Dysbiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Microbial TransplantationBiological
Also called FMT
This study will utilize donor stool from an infant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeuroblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- ProgenaBiome
- Sponsor type
- University, hospital or other
- Collaborators
- Microbiome Research Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07223606
- Sponsor's protocol ID
- IND 31935
- Other IDs
- IND 31935
- Status last verified
- Sep 2025
- First submitted
- 18 Sep 2025
- Last updated
- 3 Nov 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbiota Transplant for Neuroblastoma in a Single Patient
- ClinicalTrials.gov ID
- NCT07223606
- Acronym / sponsor ID
- IND 31935
- Conditions
- Neuroblastoma, Neuroblastoma (NB), Neuroblastoma (NBL), Neuroblastoma (Measurable Disease), Neuroblastoma Recurrent, Neuroblastoma in Children
- Keywords
- FMT, fecal transplant, fecal microbiota transplant, microbiome, dysbiosis
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- ProgenaBiomeUniversity, hospital or other
- Collaborators
- Microbiome Research Foundation
- First posted
- 3 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study uses fecal microbiota transplant (FMT) to correct gut microbiome dysbiosis prior to and during standard-of-care neuroblastoma 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 design
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- willingness of parent/guardian to sign ICF
- diagnosis of neuroblastoma
- dysbiosis of the gut microbiome
Key exclusion criteria (3 listed)
- parent/guardian unwilling to sign ICF
- dysbiosis does not show a bifidobaceteria-bacteroides gap
- severely abnormal screening lab values
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fecal Microbial TransplantationAlso: FMTThis study will utilize donor stool from an infant | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fecal Microbial Transplantation in people with Neuroblastoma and Neuroblastoma (NB), run by ProgenaBiome at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2025.