History of Changes for Study: NCT05664113

Feasibility, Safety, and Potential Efficacy of Fecal Microbiota Transplantation (FMT) for Gastrointestinal Dysfunction in Children Following Hematopoietic Cell Transplant (HCT).

A study version is represented by a row in the table.
Select two study versions to compare. One each from columns A and B.
Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
Click "Compare" to do the comparison and show the differences.
Select a version's Submitted Date link to see a rendering of the study for that version.
The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
Hover over the "Recruitment Status" to see how the study's recruitment status changed.
Study edits or deletions are displayed in red.
Study additions are displayed in green.

Study Record Versions

Version	Submitted Date	Changes
1	December 15, 2022	None (earliest Version on record)
2	January 9, 2023	Study Status
3	March 9, 2023	Study Status
4	June 2, 2023	Study Status
5	August 22, 2023	Study Status
6	October 17, 2023	Study Status
7	December 11, 2023	Study Status
8	January 11, 2024	Study Status
9	March 5, 2024	Study Status
10	March 19, 2024	Study Status and Study Identification

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	NEWGUT
Brief Title:	Feasibility, Safety, and Potential Efficacy of Fecal Microbiota Transplantation (FMT) for Gastrointestinal Dysfunction in Children Following Hematopoietic Cell Transplant (HCT).
Official Title:	Feasibility, Safety, and Potential Efficacy of Fecal Microbiota Transplantation (FMT) for Gastrointestinal Dysfunction in Children Following Hematopoietic Cell Transplant (HCT).
Secondary IDs:

Study Status


Record Verification:	August 2022
Overall Status:	Not yet recruiting
Study Start:	December 2022
Primary Completion:	December 31, 2024 [Anticipated]
Study Completion:	December 31, 2027 [Anticipated]

First Submitted:	December 15, 2022
First Submitted that Met QC Criteria:	December 15, 2022
First Posted:	December 23, 2022 [Actual]

Last Update Submitted that Met QC Criteria:	December 15, 2022
Last Update Posted:	December 23, 2022 [Actual]

Sponsor/Collaborators


Sponsor:	St. Jude Children's Research Hospital
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:	Yes
U.S. FDA-regulated Device:	No
Data Monitoring:	No

Study Description

Brief Summary:

The study participant is being asked to take part in this clinical trial, a type of research study, because the participant has Gastrointestinal (GI) symptoms following a Hematopoietic Cell Transplant (HCT).

Primary Objective

To determine the safety and feasibility of FMT for treating a GvHD of the gut following HCT.
To determine the safety and feasibility of FMT for treating HCT induced gut dysfunction.

Secondary Objectives

To assess the potential efficacy of FMT for treating a GvHD of the gut following HCT.
To assess the potential efficacy of FMT for treating HCT induced gut dysfunction.

Detailed Description:

Participants will be eligible to receive an FMT on or after Day +30 post-HCT. FMT will be performed using FMP material obtained from OpenBiome. 60 mL of FMP will be administered via NJ tube and 250 mL via colonoscopy. A second FMT may be performed at least 14 days after the initial FMT in GI clinical symptoms have partially improved or have not changed. The second FMT will be administered using the same procedure as in the initial FMT

Conditions


Conditions:	Gastro-Intestinal Disorder
Keywords:

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 1
Interventional Study Model:	Single Group Assignment
Number of Arms:	2
Masking:	None (Open Label)
Allocation:	Non-Randomized
Enrollment:	20 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Experimental: Stratum A Diagnosed with GvHD	Drug: Fecal microbiota transplant (FMT) FMT Lower Delivery Microbiota Preparation, Dose: 250 mL of Microbiota Preparation Material and Route of administration: colonoscopy FMT Upper Delivery Microbiota Preparation, Dose: 60 mL of Microbiota Preparation Material and Route of administration: Naso-enteral tube Other Names: FMT
Experimental: Stratum B GI Dysfunction	Drug: Fecal microbiota transplant (FMT) FMT Lower Delivery Microbiota Preparation, Dose: 250 mL of Microbiota Preparation Material and Route of administration: colonoscopy FMT Upper Delivery Microbiota Preparation, Dose: 60 mL of Microbiota Preparation Material and Route of administration: Naso-enteral tube Other Names: FMT

Outcome Measures


Primary Outcome Measures:
1.	Proportion of participants with a serious adverse event occurring within 30 days following FMT [ Time Frame: 30 Days ] Serious adverse events will be a primary outcome measure for the following groups: FMT for treating a GvHD of the gut following HCT FMT for treating HCT induced gut dysfunction
2.	Proportion of participants with a non-serious adverse event occurring within 30 days following FMT [ Time Frame: 30 Days ] Non-serious adverse events will be a primary outcome measure for the following groups: FMT for treating a GvHD of the gut following HCT FMT for treating HCT induced gut dysfunction
3.	Proportion of patients expressing interest who meet eligibility [ Time Frame: 2 years ] Participant eligibility will be a primary outcome measure for the following groups: FMT for treating a GvHD of the gut following HCT FMT for treating HCT induced gut dysfunction
4.	Proportion of patients recruited in the eligible population [ Time Frame: 2 years ] Participant recruitment will be a primary outcome measure for the following groups: FMT for treating a GvHD of the gut following HCT FMT for treating HCT induced gut dysfunction
5.	Proportion of participants that drop up post-enrollment [ Time Frame: 3 years ] Participant retention will be a primary outcome measure for the following groups: FMT for treating a GvHD of the gut following HCT FMT for treating HCT induced gut dysfunction
6.	Proportion of participants providing all protocol required stool samples [ Time Frame: 3 years ] Stool specimens will be a primary outcome measure for the following groups: FMT for treating a GvHD of the gut following HCT FMT for treating HCT induced gut dysfunction
Secondary Outcome Measures:
1.	Proportion of participants with a complete response or a partial response [ Time Frame: 180 days ] Complete response or partial response will be a secondary outcome measure for the following groups: FMT for treating a GvHD of the gut following HCT FMT for treating HCT induced gut dysfunction
2.	Percentage of participants who reduce or discontinue steroids at the end of the study [ Time Frame: 1 year ] Reduction in dose of steroids will be a secondary outcome measure for the following groups: FMT for treating a GvHD of the gut following HCT FMT for treating HCT induced gut dysfunction

Eligibility


Minimum Age:
Maximum Age:	22 Years
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	Inclusion Criteria: Age < 22 years old. Received an allogeneic HCT greater than or equal to 30 days prior to enrollment Diagnosed with one of the following conditions: Steroid-resistant gut a GvHD (defined as GI symptoms that do not improve within 5 days after initial steroid therapy, >/= 1mg/kg of prednisolone) OR Steroid-dependent gut a GvHD (defined as the presence of a response to methylprednisolone 2 mg/kg/day but relapsing when an attempt was made to taper steroid treatment). OR Current or prolonged GI dysfunction following HCT, defined as having diarrhea or loose stools >/= 4 weeks with at least one of the following: Requiring NG or G-tube feeds Requiring TPN or IVF for more than 4 weeks Diagnosis of gastroparesis by GI specialist documented in the medical record Willing and able to provide informed assent/consent Exclusion Criteria: Cytomegalovirus (CMV) or Epstein Barr Virus (EBV) IgG negative at the time of consent Female participant who is pregnant or nursing History of previous FMT Intra-abdominal surgery within 4 weeks of enrollment At increased risk for peritonitis: presence of intra-abdominal devices (G-or GJ-tubes are acceptable), receiving peritoneal dialysis, or ascites Concurrent abdominal radiation therapy Any acute or chronic illness/condition as well as medication that in the opinion of the investigator puts the subject at greater risk from FMT or may confound the study results.

Contacts/Locations


Central Contact Person:	Gabriela Maron, MD Telephone: 866-278-5833 Email: referrainfo@stjude.org
Study Officials:	Gabriela Maron, MD Principal Investigator St. Jude Children's Research Hospital
Locations:	United States, Tennessee
	St. Jude Children's Research Hospital Memphis, Tennessee, United States, 38105 Contact:Contact: Gabriela Maron, MD 866-278-5833 referralinfo@stjude.org

IPDSharing


Plan to Share IPD:	Yes Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.
	Supporting Information: Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF)
	Time Frame: Data will be made available at the time of article publication.
	Access Criteria: Data will be provided to researchers following a formal request with the following information: full name of requestor, affiliation, data set requested, and timing of when data is needed. As an informational point, the lead statistician and study principal investigator will be informed that primary results datasets have been requested.
	URL:

References


Citations:
Links:	URL: http://www.stjude.org Description: St. Jude Children's Research Hospital
	URL: http://www.stjude.org/protocols Description: Clinical Trials Open at St. Jude
Available IPD/Information: