Intestinal Graft Versus Host DiseasePhase 1NCT05067595
Fecal Microbiota Transplant and Dietary Fiber Supplementation for the Treatment of Gut Graft Versus Host Disease
A Phase 1 study testing Colonoscopy, Fecal Microbiota Transplantation and Nutritional Supplementation in people with Intestinal Graft Versus Host Disease, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial summary
This phase I trial studies how well fecal microbiota transplant and dietary fiber supplementation work in treating patients with gut graft versus host disease. Fecal microbiota transplant entails inoculating donor stool into a recipient's gastrointestinal tract. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intestinal Graft Versus Host Disease
- What is being tested?
- Colonoscopy, Fecal Microbiota Transplantation and Nutritional Supplementation
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2025to 31 Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- History of allogeneic hematopoietic stem cell transplant in the past 365 days
- Post-engraftment, defined by time period following three consecutive days of sustained neutrophil engraftment with an absolute neutrophil count of at least 500 cells/mm^3
- Mild to severe acute GI GvHD, at least stage 1, as measured by one of the following:
- Modified Glucksberg criteria for GI GvHD averaged over 3 consecutive days and without another explanation for diarrhea such as laxative use or infection. In patients who have already had GI biopsy, biopsy histology must be compatible with GVHD, although biopsy is not required
- Biopsy evidence of GI GVHD in the upper or lower GI tract
Who cannot join
- History of previous serious adverse events associated with FMT
- History of bowel perforation in the last 90 days
- History of gastrointestinal resection in the last 90 days
- History of small bowel obstruction without surgical intervention in the last 30 days, or 90 days with surgery, or history of large bowel obstruction in last 90 days
- History of diverticulitis in the last 60 days
- History of celiac disease confirmed by serologic testing or small bowel biopsy
Show all 13Show fewer
- History of severe dietary allergy as designated by World Allergy Organization Subcutaneous Immunotherapy Systemic Reaction Grading System grade 2 or more
- Subjects who are cytomegalovirus (CMV) seronegative at the time of enrollment as indicated by clinical testing unless the fecal microbiota transplant (FMT) donor is CMV seronegative with negative plasma polymerase chain reaction (PCR) assays for CMV.
- Known allergies to loperamide, sodium chloride, glycerol, theobroma oil, hide bovine gelatin, sodium lauryl sulfate, colorants FD\&C, titanium dioxide, polyethylene glycol, sodium sulfate, sodium bicarbonate, sodium phosphate, benzalkonium chloride, disodium EDTA or potassium chloride.
- Currently pregnant, planning to become pregnant or breastfeeding during the study period. Women of childbearing potential (those who are not post-menopausal or post-hysterectomy) must be negative for pregnancy per urine pregnancy test at enrollment
- Individuals with the ability to conceive children who are not willing to abstain from sexual activity or use an effective form of birth control during the duration of the study
- Unwilling or unable to participate in study procedures including oral intake of FMT, colonoscopy, fiber supplementation, collection of stool samples and completion study surveys
- Cannot reasonably and safely participate in the study in the opinion of the investigators
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
David Fredricks, 206-667-1935, dfredric@fredhutch.org
David Fredricks
About this study
Official title: A Randomized, Controlled, Phase I Study of Fecal Microbiota Transplant and Dietary Fiber Supplementation in Graft Versus Host Disease
This phase I trial studies how well fecal microbiota transplant and dietary fiber supplementation work in treating patients with gut graft versus host disease. Fecal microbiota transplant entails inoculating donor stool into a recipient's gastrointestinal tract. Changing the gut microbiome by fecal microbiota transplant and fiber supplementation may help treat gut graft versus host disease.
Read the detailed description
OUTLINE: Patients are randomized to 1 of 4 arms.
ARM I: Patients receive upper FMT capsules orally (PO) over 5 days or via post-pyloric or nasogastric (NG) feeding tube over 2 days.
ARM II: Patients undergo lower FMT via colonoscopy on day 0.
ARM III: Patients receive upper FMT capsules PO over 5 days or via post-pyloric or NG feeding tube over 2 days. Patients also receive fiber supplementation PO or via post-pyloric or NG feeding tube from the first day of FMT administration and up to 6 weeks post FMT.
ARM IV: Patients undergo lower FMT via colonoscopy on day 0. Patients also receive fiber supplementation PO or via post-pyloric or NG feeding tube from day 0 up to 6 weeks post FMT.
Patients also undergo tissue, stool, stool swabs, and blood sample collection throughout the study.
After completion of study treatment, patients are followed up for 365 days.
- Conditions
- Intestinal Graft Versus Host Disease
- Being tested
- Colonoscopy, Fecal Microbiota Transplantation, Nutritional Supplementation, Survey Administration, Biospecimen Collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColonoscopyProcedure or surgery
Undergo lower FMT via colonoscopy
Fecal Microbiota TransplantationBiological
Also called Fecal Material Transplantation, Fecal Transplantation, FMT, Poo Transplant
Given upper FMT PO or via post-pyloric or NG feeding tube
Fecal Microbiota TransplantationBiological
Also called Fecal Material Transplantation, Fecal Transplantation, FMT, Poo Transplant
Undergo lower FMT via colonoscopy
Nutritional SupplementationDietary supplement
Also called Supplementation
Given dietary fiber supplementation PO or via post-pyloric or NG feeding tube
Survey AdministrationOther
Ancillary studies
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection
Undergo tissue, stool, stool swabs, and blood sample collection
| Study group | Role | What they receive |
|---|---|---|
| Arm I (upper FMT) | Experimental | Patients receive upper FMT capsules PO over 5 days or via post-pyloric or NG feeding tube over 2 days. Patients also undergo tissue, stool, stool swabs, and blood sample collection throughout the study. Receives: Biological: Fecal Microbiota Transplantation; Other: Survey Administration; Procedure: Biospecimen Collection |
| Arm II (Lower FMT) | Experimental | Patients undergo lower FMT via colonoscopy on day 0. Patients also undergo tissue, stool, stool swabs, and blood sample collection throughout the study. Receives: Procedure: Colonoscopy; Biological: Fecal Microbiota Transplantation; Other: Survey Administration; Procedure: Biospecimen Collection |
| Arm III (upper FMT, fiber supplementation) | Experimental | Patients receive upper FMT capsules PO over 5 days or via post-pyloric or NG feeding tube over 2 days. Patients also receive fiber supplementation PO or via post-pyloric or NG feeding tube from the first day of FMT administration and up to 6 weeks post FMT. Patients also undergo tissue, stool, stool swabs, and blood sample collection throughout the study. Receives: Biological: Fecal Microbiota Transplantation; Dietary Supplement: Nutritional Supplementation; Other: Survey Administration; Procedure: Biospecimen Collection |
| Arm IV (Lower FMT, fiber supplementation) | Experimental | Patients undergo lower FMT via colonoscopy on day 0. Patients also receive fiber supplementation PO or via post-pyloric or NG feeding tube from day 0 up to 6 weeks post FMT. Patients also undergo tissue, stool, stool swabs, and blood sample collection throughout the study. Receives: Procedure: Colonoscopy; Biological: Fecal Microbiota Transplantation; Dietary Supplement: Nutritional Supplementation; Other: Survey Administration; Procedure: Biospecimen Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial composition of stool
Analyses will consist of summary statistics of the bacterial diversity in the microbiome (e.g., the alpha diversity, the abundance of bacterial species associated with protection from graft versus host disease [GvHD]).
Measured: At baseline
Bacterial genes in stool
Specifically abundance of genes related to fiber fermentation and short chain fatty acids production metabolites in stool, specifically short chain fatty acids will be assessed.
Measured: At baseline
Incidence of adverse events
Will by assessed by computing the total number of adverse events (AE)s and serious adverse events (SAE)s, the number per patient, and the number of patients with at least one event. The type of AE/SAE and whether the AE/SAE is related to the fecal microbiota transplant (FMT) or not will be tabulated. These summaries will be computed overall as well as by randomization arm and stratification factor (steroid-responsive, versus steroid-dependent or -refractory disease status). The odds will be compared of at least one SAE per patient by randomization arm and stratification factor using logistic regression with independent variables for route of FMT administration, fiber supplementation, and steroid-responsive, versus steroid-dependent or -refractory disease status. Interaction terms will be considered between these factors and may use exact or firth logistic regression in the event that some categories have zero patients with a SAE.
Measured: Up to 3 years
Secondary outcomes (8)
Complete response (CR) after the initial FMT
Will be defined by stage 0 on the Modified Glucksberg GvHD scale, without abdominal pain or hematochezia. To account for variability in this measure, patient stool volume (inpatients only) and survey data (both inpatients and outpatients) from days 25-27 will be used to determine whether patients meet these criteria or not. Inpatients will be a compare measured stool volumes to those reported via survey, to assess how well the survey data may serve as a surrogate for stool volume. Subjects who die before day 28 will be counted as no CR. The number and proportion of patients with CR by steroid-responsive, versus steroid-dependent or -refractory disease status, and each randomization arm (route of FMT administration and receipt of fiber supplementation) as well as within combinations of these factors will be computed. To test for differences in CR by these factors, logistic regression models similar to those described above for SAE comparisons.
Measured: At day 28
CR or partial response (PR) after the initial FMT
Will be assessed by CR or PR at day 28 will use similar analysis methods as to the CR at day 28 outcome analysis.
Measured: At day 28
Gut and overall GvHD grade
Will be assessed using the Modified Glucksberg scale measurements at baseline and throughout follow-up to summarize decrease in stool volume. For both of these ordinal outcomes (GvHD grade and Modified Glucksberg scale stage), descriptive statistics and graphical summaries to show changes over time by stratification factor and randomization arm. Generalized linear mixed effects models to test for differences in these outcomes by stratification factor and randomization arm.
Measured: Up to 6 months
Six-month survival
Will be evaluated using Kaplan-Meier curves and Cox proportional hazards regression with independent variables for the steroid- responsive, versus steroid-dependent or - refractory disease and randomization arm as specified in previous models.
Measured: At 6 months
Quality of life
Will be summarized at baseline and during study using descriptive statistics.
Measured: Up to 3 years
Decrease in stool volume
Measured: Up to 6 months
Levels of MAIT cells in the periphery
Will be assessed using plot cell counts and percentage of lymphocytes for MAIT cells over time to compare longitudinal patterns by study arm and stratification factor. Mann-Whitney tests will be used to evaluate differences in cell counts and percentage of lymphocytes for MAIT cells in recipients of upper versus lower FMT, and individuals who receive fiber supplementation versus those who do not at specific time points post-FMT. Linear mixed effects models may be used to test for differences in longitudinal patterns of these outcomes by randomization arm and stratification factor.
Measured: Up to 6 months
Levels of Treg cells in the periphery
Will be assessed using plot cell counts and percentage of lymphocytes for Treg cells over time to compare longitudinal patterns by study arm and stratification factor. Mann-Whitney tests will be used to evaluate differences in cell counts and percentage of lymphocytes for Tregs in recipients of upper versus lower FMT, and individuals who receive fiber supplementation versus those who do not at specific time points post-FMT. Linear mixed effects models may be used to test for differences in longitudinal patterns of these outcomes by randomization arm and stratification factor.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2021
- Study start24 Jan 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestinal Graft Versus Host DiseaseStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- David Fredricks, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05067595
- Sponsor's protocol ID
- RG1006202
- Other IDs
- NCI-2019-07698, 10276, 1R01HL166107
- Status last verified
- Sep 2026
- First submitted
- 10 Dec 2019
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Phase I Study of Fecal Microbiota Transplant and Dietary Fiber Supplementation in Graft Versus Host Disease
- ClinicalTrials.gov ID
- NCT05067595
- Acronym / sponsor ID
- RG1006202
- Conditions
- Intestinal Graft Versus Host Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 24 Jan 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 5 Oct 2021 (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 phase I trial studies how well fecal microbiota transplant and dietary fiber supplementation work in treating patients with gut graft versus host disease. Fecal microbiota transplant entails inoculating donor stool into a recipient's gastrointestinal tract. Changing the gut microbiome by fecal microbiota transplant and fiber supplementation may help treat gut graft versus host disease.
Detailed description
OUTLINE: Patients are randomized to 1 of 4 arms.
ARM I: Patients receive upper FMT capsules orally (PO) over 5 days or via post-pyloric or nasogastric (NG) feeding tube over 2 days.
ARM II: Patients undergo lower FMT via colonoscopy on day 0.
ARM III: Patients receive upper FMT capsules PO over 5 days or via post-pyloric or NG feeding tube over 2 days. Patients also receive fiber supplementation PO or via post-pyloric or NG feeding tube from the first day of FMT administration and up to 6 weeks post FMT.
ARM IV: Patients undergo lower FMT via colonoscopy on day 0. Patients also receive fiber supplementation PO or via post-pyloric or NG feeding tube from day 0 up to 6 weeks post FMT.
Patients also undergo tissue, stool, stool swabs, and blood sample collection throughout the study.
After completion of study treatment, patients are followed up for 365 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm I (upper FMT) | Experimental | Biological: Fecal Microbiota Transplantation, Other: Survey Administration, Procedure: Biospecimen CollectionPatients receive upper FMT capsules PO over 5 days or via post-pyloric or NG feeding tube over 2 days. Patients also undergo tissue, stool, stool swabs, and blood sample collection throughout the study. |
| Arm II (Lower FMT) | Experimental | Procedure: Colonoscopy, Biological: Fecal Microbiota Transplantation, Other: Survey Administration, Procedure: Biospecimen CollectionPatients undergo lower FMT via colonoscopy on day 0. Patients also undergo tissue, stool, stool swabs, and blood sample collection throughout the study. |
| Arm III (upper FMT, fiber supplementation) | Experimental | Biological: Fecal Microbiota Transplantation, Dietary Supplement: Nutritional Supplementation, Other: Survey Administration, Procedure: Biospecimen CollectionPatients receive upper FMT capsules PO over 5 days or via post-pyloric or NG feeding tube over 2 days. Patients also receive fiber supplementation PO or via post-pyloric or NG feeding tube from the first day of FMT administration and up to 6 weeks post FMT. Patients also undergo tissue, stool, stool swabs, and blood sample collection throughout the study. |
| Arm IV (Lower FMT, fiber supplementation) | Experimental | Procedure: Colonoscopy, Biological: Fecal Microbiota Transplantation, Dietary Supplement: Nutritional Supplementation, Other: Survey Administration, Procedure: Biospecimen CollectionPatients undergo lower FMT via colonoscopy on day 0. Patients also receive fiber supplementation PO or via post-pyloric or NG feeding tube from day 0 up to 6 weeks post FMT. Patients also undergo tissue, stool, stool swabs, and blood sample collection throughout the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years of age or older
- History of allogeneic hematopoietic stem cell transplant in the past 365 days
- Post-engraftment, defined by time period following three consecutive days of sustained neutrophil engraftment with an absolute neutrophil count of at least 500 cells/mm^3
- Mild to severe acute GI GvHD, at least stage 1, as measured by one of the following:
Key exclusion criteria (13 listed)
- History of previous serious adverse events associated with FMT
- History of bowel perforation in the last 90 days
- History of gastrointestinal resection in the last 90 days
- History of small bowel obstruction without surgical intervention in the last 30 days, or 90 days with surgery, or history of large bowel obstruction in last 90 days
- History of diverticulitis in the last 60 days
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 |
|---|---|---|
| ColonoscopyUndergo lower FMT via colonoscopy | Procedure or surgery | Arm II (Lower FMT), Arm IV (Lower FMT, fiber supplementation) |
| Fecal Microbiota TransplantationAlso: Fecal Material Transplantation, Fecal Transplantation, FMT, Poo TransplantGiven upper FMT PO or via post-pyloric or NG feeding tube | Biological | Arm I (upper FMT), Arm III (upper FMT, fiber supplementation) |
| Fecal Microbiota TransplantationAlso: Fecal Material Transplantation, Fecal Transplantation, FMT, Poo TransplantUndergo lower FMT via colonoscopy | Biological | Arm II (Lower FMT), Arm IV (Lower FMT, fiber supplementation) |
| Nutritional SupplementationAlso: SupplementationGiven dietary fiber supplementation PO or via post-pyloric or NG feeding tube | Dietary supplement | Arm III (upper FMT, fiber supplementation), Arm IV (Lower FMT, fiber supplementation) |
| Survey AdministrationAncillary studies | Other | Arm I (upper FMT), Arm II (Lower FMT), Arm III (upper FMT, fiber supplementation), Arm IV (Lower FMT, fiber supplementation) |
| Biospecimen CollectionAlso: Biological Sample CollectionUndergo tissue, stool, stool swabs, and blood sample collection | Procedure or surgery | Arm I (upper FMT), Arm II (Lower FMT), Arm III (upper FMT, fiber supplementation), Arm IV (Lower FMT, fiber supplementation) |
Primary outcome
Bacterial composition of stool
Time frame: At baseline
Analyses will consist of summary statistics of the bacterial diversity in the microbiome (e.g., the alpha diversity, the abundance of bacterial species associated with protection from graft versus host disease [GvHD]).
Bacterial genes in stool
Time frame: At baseline
Specifically abundance of genes related to fiber fermentation and short chain fatty acids production metabolites in stool, specifically short chain fatty acids will be assessed.
Incidence of adverse events
Time frame: Up to 3 years
Will by assessed by computing the total number of adverse events (AE)s and serious adverse events (SAE)s, the number per patient, and the number of patients with at least one event. The type of AE/SAE and whether the AE/SAE is related to the fecal microbiota transplant (FMT) or not will be tabulated. These summaries will be computed overall as well as by randomization arm and stratification factor (steroid-responsive, versus steroid-dependent or -refractory disease status). The odds will be compared of at least one SAE per patient by randomization arm and stratification factor using logistic regression with independent variables for route of FMT administration, fiber supplementation, and steroid-responsive, versus steroid-dependent or -refractory disease status. Interaction terms will be considered between these factors and may use exact or firth logistic regression in the event that some categories have zero patients with a SAE.
8 secondary outcomes
Complete response (CR) after the initial FMT
Time frame: At day 28
CR or partial response (PR) after the initial FMT
Time frame: At day 28
Gut and overall GvHD grade
Time frame: Up to 6 months
Six-month survival
Time frame: At 6 months
Quality of life
Time frame: Up to 3 years
Decrease in stool volume
Time frame: Up to 6 months
Levels of MAIT cells in the periphery
Time frame: Up to 6 months
Levels of Treg cells in the periphery
Time frame: Up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No
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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.
David Fredricks principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Colonoscopy, Fecal Microbiota Transplantation and Nutritional Supplementation in people with Intestinal Graft Versus Host Disease, run by Fred Hutchinson Cancer Center 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 6 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 11 Sep 2026. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Fredricks (206.667.1935, dfredric@fredhutch.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bacterial composition of stool (time frame: At baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 11 Sep 2026.