An Early Phase 1 interventional study of Fecal Microbial Transplantation in Clostridium Difficile Infection, Ulcerative Colitis and Indeterminate Colitis, sponsored by Stony Brook University. Completed at 1 site in United States. Open to participants aged 7 Years and older. Per ClinicalTrials.gov, last updated 2022-02-22.
Sponsored by Stony Brook University · Early Phase 1, Interventional, and Treatment
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Among 121 studies in Clostridium Infections with a site in United States — 16 open to participants now, 19 under way, 3 of them phase 3. Clostridium Infections · United States.
Among the 121 studies in Clostridium Infections with a site in United States, this one is the 80th largest by enrollment of the 102 interventional ones that give a count, is one of 9 that started in 2013, is one of 18 in phase 1, and was the 41st registered.
251 studies on the registry are indexed under Clostridium Infections; 51 are open to participants now.
Browse Clostridium Infections studies →16 of the 121 studies in Clostridium Infections with a site in United States are open now. Recruiting first, the newest first:
National Institute of Allergy and Infectious Diseases (NIAID) · Sites in United States
Ages 18–75 · Healthy volunteers
Acurx Pharmaceuticals Inc. · Sites in United States
Ages 18–90
Medical College of Wisconsin · Sites in United States
Ages 18+
University of Michigan · Sites in United States
Ages 18+
AstraZeneca · Sites in United States, Australia, Canada and 11 more countries
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 36 Clostridium Infections studies recruiting now, 22 (61%) set no upper age limit and 8 (22%) stop at 75 or younger; 9 take children under 18; 3 take healthy volunteers.
This study: 7 Years and older · all sexes · no healthy volunteers.
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121 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 21 · Phase 2 40 · Phase 3 21 · Phase 4 14
First in 1998; this study’s year is marked. 9 started in 2013.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 12 is below the median of 64 across 185 interventional studies indexed under Clostridium Infections.
Median enrollment 57 across the 102 interventional studies, 132 across the 19 observational. Of the 91 that completed or were terminated, 52 (57%) have results posted.
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48 of 121 have an industry lead sponsor. The 10 most frequent:
Stony Brook University is the lead sponsor of 197 studies on the registry; 35 are open to participants now.
Of its 24 completed or terminated interventional studies of FDA-regulated products, 11 (46%) have results posted.
Stony Brook University has 1 study filed under Clostridium Infections — fewer than ten, so there is no comparison to draw.
7 of the studies in Clostridium Infections with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07221370Phase 3Riverside University Health System Medical CenterEnteral Vancomycin as Primary Prophylaxis Against Clostridioides Difficile Infection in Critically Ill Patients | 2026-12-31 |
| NCT06237452Phase 3Vedanta Biosciences, Inc.VE303 for Prevention of Recurrent Clostridioides Difficile Infection | 2027-06 |
| NCT04305769University of VirginiaAlanyl-glutamine Supplementation for C. Difficile Treatment (ACT) | 2026-12-31 |
| NCT07250724Bactolife A/SC. Difficile Toxin Levels in Stool From Healthy Individuals Following Standard of Care Antibiotic Treatment for CDI. | 2027-01-15 |
| NCT07285213AstraZenecaPrevention of Recurrent C. Difficile Infection Study With AZD5148 Monoclonal Antibody | 2027-04-20 |
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Among the 121 studies in Clostridium Infections with a site in United States, from their registry updates:
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Fecal Microbiota Transplantation will be offered to eligible C. difficile patients (does not require Investigational New Drug designation) and to eligible ulcerative colitis or indeterminate colitis patients as Investigational New Drug treatment
The following hypothesis will be tested in this study:
Primary objectives:
Secondary objectives:
1a. To determine the long term safety and tolerability of fecal microbiota transplantation up to 1 year post-transplant in patients with recurrent or refractory Clostridium difficile and medication refractory Ulcerative colitis or indeterminate colitis.
1b. To determine the efficacy of fecal microbiota transplantation in patients with recurrent or refractory Clostridium difficile defined as no recurrence of C. difficile within one year.
For C. difficile patients/recipients only:
Inclusion:
2b. At least two episodes of severe C. difficile infection (>6 diarrheal stools/day requiring hospitalization and associated with significant morbidity).
2c. Moderate C. difficile infection (3-6 diarrheal stools/day not responding to successive standard therapy, e.g. metronidazole, vancomycin and/or fidaxomicin) lasting at least 28 days.
2d. Severe and/or fulminant C. difficile colitis (> 6 diarrheal stools/day) with no response to standard therapy after 48 hours.
Exclusion:
For patients with ulcerative and indeterminate colitis only:
Inclusion:
2a. treated with therapy for at least one month. 2b. treated with immunomodulatory therapy for at least one month 2c. treated with biological therapy for at least one month.
Exclusion:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Treated with fecal microbial transplantation
Biological: Fecal Microbial Transplantation
Fecal microbial transplant is offered as treatment option to eligible patients. Donors selected by the patients will be screened by questionnaire and by blood and stool tests for potential transmissible pathogens. The stool filtrate will be administered in the ileum and/or cecum via colonoscopy
Also known as: FMT
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Number of participants with treatment-related adverse events with grade greater than 2 within one year after FMT will be reported. Safety will be assessed as a report of no new medical condition after the transplant, Tolerability, as recorded by report of no serious adverse events after the transplant and Efficacy of the procedure will be recorded as improvement in clinical symptoms during any clinically indicated colonoscopies after the transplant as compared to before transplant C. Diff patients will have a negative C. diff test report after the transplant as an out come measure.
Time frame: 9 years
To measure the effect of fecal microbial transplantation on microbial diversity in healthy donor stools compared to pre-FMT, 1 week post FMT, and 12 weeks post-FMT recipient stools.
Fecal DNA samples will undergo V3-V4 16S rRNA sequencing. Operational taxonomic units (OTUs) will be produced by clustering sequences with identical taxonomic assignments. Alpha diversity indices (e.g. Chao1, Shannon complexity H, Shannon Evenness H/Hmax) will be calculated inferred through 1000 replicate resamplings using Explicet. Beta diversity (Bray-Curtis and Jaccard distances) will be calculated for the recipient Pre-FMT, 1 week post-FMT and 12 weeks post-FMT as compared to their pared donor using the adonis function in the R vegan package at the phyla, family and genus level. A linear mixed model will be used to compare alpha-diversity (ShannonH) and beta-diversity (Bray-Curtis and Jaccard distance) between each timepoint (FMT) and each disease group (Group). P-values less than 0.05 were considered as statistically significant.
Time frame: 10 years
To measure the effect of fecal microbial transplantation on microbial composition in healthy donor stools compared to pre-FMT, 1 week post FMT, and 12 weeks post-FMT recipient stools.
Fecal DNA samples will undergo V3-V4 16S rRNA sequencing. Operational taxonomic units (OTUs) will be produced by clustering sequences with identical taxonomic assignments. Linear mixed models analyses on individual OTUs at the genus level will be conducted on 105 OTUs after eliminating OTUs with an average relative abundance of \< 0.001% in the donor and recipient pre-FMT samples, and after discarding OTUs where more than 75% of the samples had a zero count. To compare the relative abundance of each OTU between timepoints before and after FMT \[pre-transplant recipient, 1-wk. post-FMT recipient, 3-mos. post-FMT recipient\] and each disease group, a generalized linear mixed model (GLMM) or generalized estimating equation (GEE) will be used by taking the actual counts of each OTU as the outcomes that were assumed to follow a negative binomial distribution. The p-values will be adjusted for multiple comparisons by the Bonferroni correction or by the Benjamin-Hochberg method (FDR \< 0.05).
Time frame: 10 years
To measure the effect of fecal microbial transplantation on microbial function using shotgun DNA metagenomic in healthy donor stools compared to pre-FMT, 1 week post FMT, and 12 weeks post-FMT recipient stools.
Fecal DNA samples will undergo shotgun DNA metagenomics sequencing. After removing human sequences, the Reads per kilobase gene length (RKP) will be calculated using HUMANN2 software for individual bacterial proteins/enzymes and pathways. . A linear mixed model will be used to compare RPK associated with pathways and individual proteins between each timepoint (FMT) and each disease group (Group). P-values less than 0.05 were considered as statistically significant.Linear mixed models analyses on the RPK associated with individual genes and pathways will be analyzed using linear mixed models between timepoints before and after FMT \[pre-transplant recipient, 1-wk. post-FMT recipient, 3-mos. post-FMT recipient\] and each disease group, a generalized linear mixed model (GLMM) or generalized estimating equation (GEE) were used by taking the actual RPK as the outcomes that will be assumed to follow a negative binomial distribution.
Time frame: 10 years
To measure the effect of fecal microbial transplantation on microbial function using bacterial metatranscriptomic sequencing
Fecal RNA samples will undergo bacterial metatranscriptomic RNA sequencing. After removing human sequences, the Reads per kilobase transcript (RKP) will be calculated for individual bacterial proteins/enzymes and pathways. A linear mixed model will be used to compare RPK associated with pathways and individual proteins between each timepoint (FMT) and each disease group (Group). P-values less than 0.05 were considered as statistically significant.
Time frame: 10 years
To measure the effect of fecal microbial transplantation on microbial function using targeted metabolomic assays.
Fecal samples will undergo extraction for targeted metabolomics analysis of short chain fatty acids (micrograms/gram stool) using gas chromatography-mass spectrometry, and of bile acids (microgram/gram stool) using liquid chromatography-mass spectrometry. A linear mixed model will be used to compare respectively short chain fatty acid and bile acid metabolites between each timepoint (FMT) and each disease group (Group). P-values less than 0.05 were considered as statistically significant.
Time frame: 10 years
Determine if FMT causes a statistically significant change in recipient fecal calprotectin levels
Fecal calprotectin (microgram/gram stool) levels will be measured as in the recipient at baseline pre-FMT, 1 week, and 12 weeks post FMT. A linear mixed model will be used to compare fecal calprotectin levels between each timepoint (FMT) and each disease group (Group). P-values less than 0.05 were considered as statistically significant.
Time frame: 10 years
Determine number of C. difficile recipients who have recurrent C. difficile within a year after fecal microbial transplant
Currently the efficacy of colonoscopic FMT is approximately 90% after 12 weeks. However it may be lower with patients who also have inflammatory bowel disease. We will quantify the efficacy of fecal microbial transplant on C. difficile recurrence within a year in patients with C. difficile without inflammatory bowel diseases, C. difficile with Crohn's disease and C. difficile with ulcerative or indeterminate colitis.
Time frame: 10 years
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
The record gives a start of Nov 2013, a primary completion of Feb 2022 and a completion of Feb 2022. It does not say whether these dates are actual or estimated.
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Studies of the drug tested here: Fecal microbiota