A Multi-centre, Randomised Controlled Trial Comparing Fecal Microbiota Transplantation to Placebo in an Expanded Ulcerative Colitis Population: a Feasibility Study (FRONTIER-UC)

This is a multi-centre, randomised controlled trial comparing fecal microbiota transplantation to placebo in an expanded ulcerative colitis population: a feasibility study (FRONTIER-UC) to determine whether a full-scale randomized controlled trial (RCT) to investigate fecal microbiota transplantation (FMT) in ulcerative colitis (UC) is feasible.

Start Date01 Mar 2026

Sponsor / Collaborator

University of Alberta

[+1]

ACTRN12624000120572

/ RecruitingNot ApplicableIIT

A Pilot Study of the Efficacy and Safety of Faecal Microbiota Transplant for the Treatment of Immune Checkpoint Inhibitor Colitis

Start Date05 Jun 2024

Sponsor / Collaborator

Monash University

NCT05835219

/ CompletedNot Applicable

REBYOTA™ for the Prevention of Recurrence of Clostridioides Difficile Infection (CDI) in Adult Patients: An Observational Study

This is a prospective observational cohort study designed to collect data on patients who received REBYOTA™ for the prevention of rCDI in the routine care setting. As all data collected for this study are observational, the decision to prescribe REBYOTA™ is at the treating physician's discretion and independent from the decision to enroll the patient in the study. Data will be collected from patients' medical records after obtaining informed consent. Data about clinical history, CDI events (primary and recurrent: severity, treatment), CDI-related symptoms, treatments, medical procedures, Adverse Events(AEs), and healthcare resource utilization (i.e., hospitalizations and re-admissions) will be collected through 6 months of follow-up from the date of REBYOTA™ administration.

Start Date19 Jun 2023

Sponsor / Collaborator

Ferring Pharmaceuticals A/S

100 Clinical Results associated with Fecal microbiota, live-jslm(University of Alberta)

100 Translational Medicine associated with Fecal microbiota, live-jslm(University of Alberta)

100 Patents (Medical) associated with Fecal microbiota, live-jslm(University of Alberta)

Literatures (Medical) associated with Fecal microbiota, live-jslm(University of Alberta)

31 Dec 2026·Gut Microbes

Distinct T and innate-like lymphocyte reprogramming following lyophilized fecal microbiota transplantation in recurrent C. difficile infection

Article

Author: Elahi, Shokrollah ; Gao, Yunfeng ; Kao, Dina ; Monaghan, Tanya M ; Shahbaz, Shima

Fecal microbiota transplantation (FMT) is highly effective in preventing recurrent Clostridioides difficile infection (rCDI), yet its immunological mechanisms remain poorly defined. While bacterial engraftment and recovery of microbial diversity are central to FMT efficacy, accumulating evidence suggests that host immune reprogramming is involved. In murine models, regulatory CD4⁺ T cells are indispensable for clearing C. difficile. To address this mechanistic gap, we examined systemic immune reprogramming following FMT by performing flow cytometry and single-cell RNA sequencing (scRNA-seq) on a subset of successfully treated participants from a clinical trial comparing lyophilized FMT (LFMT) with lyophilized sterile fecal filtrate (LSFF, no live bacteria) for preventing rCDI. Flow cytometry was performed on peripheral mononuclear cells from 19 LFMT recipients and 18 LSFF recipients, and scRNA-seq analysis was performed on two LFMT recipients. Although flow cytometry results did not show significant changes in the assessed markers after rCDI resolution in either treatment group, exploratory scRNA-seq in the two LFMT recipients revealed distinct LFMT-associated transcriptional signatures across adaptive and innate-like lymphocyte populations. LFMT was associated with upregulated activation and regulatory genes (CD69, STAT1, TOX, RORA, FOXP3) in CD4⁺ and CD8⁺ T cells, suggesting enhanced immune regulation with reduced cytotoxic gene expression (GZMB, PRF1, GNLY). Innate-like lymphocytes displayed broad activation, with natural killer cells showing increased KLRD1, PRF1, and IL2RB and mucosal-associated invariant T cells (MAIT cells) upregulating STAT1, JUN, and RORA while downregulating KLRB1 and STAT3. These transcriptional programs are consistent with recalibration of T cell homeostasis and innate-like lymphocyte activation, potentially driven by microbial restoration. Collectively, this exploratory study provides the first single-cell immune atlas of LFMT in rCDI, identifying coordinated activation of regulatory, effector, and innate immune pathways. Given the small sample size, these findings should be considered hypothesis-generating, requiring validation in larger cohorts.

01 Mar 2026·Infectious Diseases and Therapy

Safety and Efficacy of Fecal Microbiota, Live-jslm for Prevention of Recurrent Clostridioides difficile Infection Among Hospitalized Participants in PUNCH CD3-OLS

Article

Author: Reilly, Joseph ; Axelrad, Jordan E ; Lodise, Thomas P ; Guthmueller, Beth ; Skinner, Andrew M ; Srivastava, Shivam

INTRODUCTION:

Fecal microbiota, live-jslm (RBL) is the first single-dose, microbiota-based product approved by the US Food and Drug Administration and Health Canada to prevent recurrent Clostridioides difficile infection (rCDI) following standard-of-care antibiotics. The phase 3 PUNCH CD3-OLS study enrolled participants with numerous comorbidities and permitted inclusion of participants hospitalized due to rCDI. The safety and efficacy of RBL were evaluated in this subgroup analysis of hospitalized participants from PUNCH CD3-OLS.

METHODS:

The hospitalization subgroup included participants hospitalized for rCDI within 90 days prior to RBL administration. Participants received a single dose of RBL 24-72 h after completion of standard-of-care antibiotic treatment for rCDI. These exploratory analyses evaluated the number of participants with RBL- or administration-related treatment-emergent adverse events (TEAEs), treatment success at 8 weeks, sustained clinical response at 6 months, and incidence of rehospitalization for rCDI during study participation.

RESULTS:

The hospitalization subgroup included 74 of 697 (10.6%) participants. Within 6 months following RBL administration, 47 (63.5%) and 350 (56.7%) participants in the hospitalization and nonhospitalization subgroups experienced TEAEs, respectively; most TEAEs were of mild to moderate severity. Serious TEAEs in the hospitalization subgroup were frequently related to preexisting conditions; none were related to RBL or its administration. Most participants (87.8% [65/74]) in the hospitalization subgroup were not rehospitalized within 6 months. Treatment success at 8 weeks was 62.5% (45/72) and 75.1% (449/598) among participants in the hospitalization and nonhospitalization subgroups, respectively. Of those achieving treatment success, 86.7% (39/45) and 91.3% (410/449) had sustained clinical response through 6 months in the hospitalization and nonhospitalization subgroups, respectively.

CONCLUSION:

RBL was safe and effective in a subgroup of hospitalized participants in the PUNCH CD3-OLS study. Efficacy in this subgroup was slightly lower than in nonhospitalized participants, but rCDI-related rehospitalization remained rare.

TRIAL REGISTRATION:

NCT03931941.

01 Jan 2026·Progress in Molecular Biology and Translational Science

Live biotherapeutics in the clinic: Regulatory pathways, market dynamics, and future trends

Review

Author: Das, Bhabatosh

Live Biotherapeutic Products (LBPs), as defined by the U.S. Food and Drug Administration, are biological products containing live microorganisms intended for the prevention, treatment, or cure of human disease. Distinct from vaccines, their therapeutic effects derive from the biological activity of the living organism itself, including intrinsic functions and, where applicable, metabolites produced in situ. LBPs may originate from human or environmental sources or be rationally designed and are developed, manufactured, and regulated as drugs or biologics for clinical use. Once confined to experimental research, LBPs are now transitioning into approved therapeutics. The approvals of Rebyota and Vowst for recurrent Clostridioides difficile infection mark a pivotal milestone, establishing LBPs as a new therapeutic class. Although the global LBP market currently remains in the tens to low hundreds of millions of U.S. dollars, it is projected to grow at compound annual rates of approximately 13-25 %, with estimates ranging from USD 400 million to 2.6 billion by 2030-2034. Emerging recombinant LBPs further expand this paradigm, enabling enzymatic and peptide drug synthesis and precision delivery platforms. In parallel, regulatory frameworks are evolving, with both the FDA and EMA defining pathways that emphasize quality control, donor sourcing, potency, biosafety, and environmental risk assessment, particularly for genetically modified organisms. Commercial opportunities are driven by unmet needs in gastrointestinal, immune, and metabolic disorders, with potential extension into oncology. Progress, however, is tempered by manufacturing complexity, regulatory burden, reimbursement challenges, public perception, and incomplete mechanistic understanding. Despite these hurdles, the future is compelling, marked by expanding indications, engineered strains, standardized consortia, scalable manufacturing, regulatory harmonization, and accelerating investment.

News (Medical) associated with Fecal microbiota, live-jslm(University of Alberta)

03 Apr 2026

·allsci.com

Data committee gives nod for Vedanta’s VE303 to advance in Phase III for C. difficile infection prevention

Vedanta Biosciences reported that an independent data monitoring committee has recommended the Phase III RESTORATiVE303 trial of VE303 continue without modification following a prespecified interim analysis, with the DMC determining that efficacy exceeded the futility threshold and no new safety signals had emerged. RESTORATiVE303 is a randomized, double-blind, placebo-controlled, multinational Phase III trial enrolling patients at high risk for recurrent Clostridioides difficile infection (CDI) across more than 150 sites in approximately 20 countries, with participants randomized 2:1 to a 14-day course of VE303 or placebo. The interim analysis was triggered when 50% of planned enrollees had reached the Week 8 primary efficacy timepoint, which is the CDI recurrence rate at that mark. No numerical efficacy or safety data were disclosed; the DMC’s mandate in a blinded trial is limited to assessing whether accumulating data fall within prespecified statistical boundaries, and a continuation recommendation indicates the trial retains adequate power to detect the primary endpoint at protocol-defined sample size. The DMC reported no significant adverse events or new safety signals. Vedanta anticipates completing enrollment in the second half of 2026, with a second interim analysis also planned for that period. VE303 is a live biotherapeutic product consisting of a defined consortium of eight bacterial strains produced from pure, clonal cell banks — a manufacturing approach that bypasses donor fecal material entirely. In the Phase II CONSORTiUM study, high-dose VE303 achieved a 30.5% adjusted absolute risk reduction in CDI recurrence versus placebo, corresponding to a greater than 80% reduction in the odds of recurrence. The Phase III trial is intended to support a Biologics License Application to the FDA. VE303 holds Orphan Drug Designation (2017) and Fast Track Designation (2023). The recurrent CDI prevention space now contains two FDA-approved microbiome-based live biotherapeutics: Vowst (fecal microbiota spores, live-brpk), approved in April 2023, and Rebyota (fecal microbiota, live-jslm), approved in November 2022. Both are donor-derived products — Vowst administered orally and Rebyota rectally — and both demonstrated reduced recurrence versus placebo in their pivotal trials. VE303’s defined, non-donor-derived composition is its primary structural distinction from these approved competitors. Cross-trial comparisons are limited by differences in patient populations, prior CDI episode counts, qualifying antibiotic regimens, and endpoint definitions, so Phase II data for VE303 cannot be directly benchmarked against pivotal data for Vowst or Rebyota. The CDI market also includes bezlotoxumab (Zinplava), a monoclonal antibody that neutralizes C. difficile toxin B and is administered as a single IV infusion adjunct during antibiotic therapy, and fidaxomicin (Dificid), the narrow-spectrum antibiotic that is guideline-preferred for recurrent CDI treatment and is itself part of the standard-of-care backdrop in RESTORATiVE303 — the trial enrolls a proportion of patients receiving fidaxomicin for their qualifying CDI episode. VE303 is positioned as a post-antibiotic microbiome restoration agent, complementary to rather than competitive with antibiotic treatment. Your email address will not be published. Required fields are marked * Comment * Name * Email * Website

Clinical ResultPhase 3Orphan DrugPhase 2Fast Track

02 Apr 2026

·www.fiercebiotech.com

‘Portfolio assessment’ prompts Ferring to terminate 2 fertility trials

With the newly terminated trials, Ferring seems to have no ongoing clinical work in reproductive medicine save for an observational study of Rekovelle in Asian countries.\n Ferring Pharmaceuticals is halting work on two trials of a phase 1 infertility candidate that together had enrolled 416 patients. The Celestial-1 and Celestial-2 trials, testing the pairing of choriogonadotropin beta (coded as FE999302) with Ferring’s own approved fertility med Rekovelle, have been terminated as part of “a broader portfolio assessment,” according to a notice in the federal clinical trial database. The decision was not the result of any safety concerns, the notice says.The Celestial trials were testing whether FE999302 could improve pregnancy rates when combined with Rekovelle, which is a form of follicle-stimulating hormone.The decision reflects “the desire to focus on programs that can bring timely and meaningful benefit to patients,” Ferring wrote in the database.“We continuously assess and prioritize our pipeline,” a Ferring spokesperson told Fierce Biotech, noting that the terminations are not related to the Swiss pharma’s reorganization last October. Ferring laid off 500 employees, around 7% of its workforce, as part of that streamlining.The spokesperson did not respond to follow-up questions from Fierce on the status of FE999302 going forward.Those October job cuts were meant to align with Ferring’s so-called Enterprise Model to “sharpen strategic focus, improve cost efficiencies, flexibility, and free up resources for reinvestment in innovation, whilst promoting [Ferring’s] financial stability and sustainable growth,” the company said at the time.Not long after announcing the workforce reduction, Ferring revealed it was slowing down commercial efforts for Rebyota, the first fecal microbiota product to be approved by the FDA, as it explored strategic options for the drug.These decisions followed an earlier layoff round and the shuttering of a research site in 2023. With the newly terminated trials, Ferring appears to have no ongoing clinical work in reproductive medicine, save for an observational study of Rekovelle in Asian countries. Several infertility studies listed in the company’s pipeline have been completed.Additionally, a study testing Rekovelle’s ability to improve male fertility, called Adam, was scrapped in 2024 due to slow enrollment, while an investigational treatment for inadequate milk production vanished from the pipeline in 2023.When canceling Adam, Ferring said that the move “was not due to safety concerns nor changes in Ferring\'s reproductive medicine strategy or interest in developing treatments for male infertility,” according to the clinical trial database.Ferring reported record revenue of more than 2.5 billion euros in 2025, largely powered by the pharma’s flagship fertility drug Menopur.

Phase 1

29 Oct 2025

·www.businesswire.com

Ferring Pharmaceuticals to Explore Strategic Options for Rebyota ®

SAINT-PREX, Switzerland--(BUSINESS WIRE)--As part of our ongoing transformation to sharpen our focus, we have decided to explore strategic options for Rebyota® (faecal microbiota, live – jslm). To date, more than five thousand patients suffering from recurrent Clostridioides difficile infection (rCDI) have found new hope when treated with Rebyota®. Without commercial critical mass in this therapy area at Ferring, we believe that this first-in-class, innovative product could benefit many more patients with a new approach to its continued commercialisation. As a result, Ferring will reduce commercial efforts in the United States while ensuring uninterrupted access for patients. Approved by the U.S. Food and Drug Administration (FDA) in 2022, Rebyota® was the first FDA-approved faecal microbiota transplant, indicated for the prevention of rCDI in adults following antibiotic treatment for recurrent CDI. This milestone marked a significant advancement in understanding the role of the human microbiome in health and disease. Ferring remains committed to advancing the science of the human microbiome to address significant unmet medical needs. The company intends to build on the valuable insights gained from the development and commercialisation of Rebyota® as it continues its efforts to advance second-generation microbiome therapies (non-donor-based, oral solutions designed to offer greater convenience for both healthcare professionals and patients) across other indications. About Ferring Pharmaceuticals Ferring Pharmaceuticals is a privately owned specialty biopharmaceutical group committed to building families and helping people live better lives. We are leaders in reproductive medicine with a strong heritage in gastroenterology and urology and are at the forefront of innovation in uro-oncology gene therapy. Ferring was founded in 1950 and employs more than 7,500 people worldwide. The company is headquartered in Saint-Prex, Switzerland, and has operating subsidiaries in more than 50 countries which market its medicines in over 100 countries. Learn more at www.ferring.com, or connect with us on LinkedIn, Instagram, YouTube, Facebook and X. About Rebyota® Rebyota is a pre-packaged, single-dose 150 mL microbiota suspension for rectal administration consisting of a liquid mix of up to trillions of live microbes – including Bacteroides. Rebyota is delivered directly to the gut microbiome and is administered by a healthcare professional in one visit. Indication Rebyota® (faecal microbiota, live – jslm) is indicated for the prevention of recurrence of Clostridioides difficile (C. diff) infection in individuals 18 years of age and older, following antibiotic treatment for recurrent C. diff infection. Limitation of Use Rebyota is not indicated for the treatment of C. diff infection. Important Safety Information You should not receive Rebyota if you have a history of a severe allergic reaction (e.g., anaphylaxis) to Rebyota or any of its components. You should report to your doctor any infection you think you may have acquired after administration. Rebyota may contain food allergens. Most common side effects may include stomach pain (8.9%), diarrhoea (7.2%), bloating (3.9%), gas (3.3%), and nausea (3.3%). Rebyota has not been studied in patients below 18 years of age. Clinical studies did not determine if adults 65 years of age and older responded differently than younger adults. You are encouraged to report negative side effects of prescription drugs to FDA. Visit www.FDA.gov/medwatch or call 1-800-332-1088. Please click to see the full Prescribing Information.

Drug ApprovalMicrobial therapyClinical Result

100 Deals associated with Fecal microbiota, live-jslm(University of Alberta)

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Clostridioides difficile infection recurrence	United States	Ferring Pharmaceuticals, Inc.	30 Nov 2022

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Clostridium Infections	NDA/BLA	Switzerland	FERRING BV	05 Sep 2022
Communicable Diseases, Imported	Phase 3	United States	Rebiotix, Inc.	30 Jul 2019
Communicable Diseases, Imported	Phase 3	Canada	Rebiotix, Inc.	30 Jul 2019
Clostridium difficile colitis	Phase 3	Canada	University of Alberta	18 Sep 2014
Clostridium difficile infection	Phase 3	Canada	University of Alberta	18 Sep 2014
Obsessive-Compulsive Disorder	Phase 2	Canada	University of Calgary	01 Jun 2023
Colitis, Ulcerative	Phase 2	Canada	University of Alberta	03 Jun 2022
Metabolic Syndrome	Phase 2	Canada	University of Alberta	01 Jul 2018
Obesity	Phase 2	Canada	University of Alberta	01 Jul 2018
Urinary Tract Infections	Phase 2	United States	Rebiotix, Inc.	08 Feb 2018

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05835219 (ROAR, DDW2026)	Not Applicable	Clostridium difficile infection	142	REBYOTA	qdmpyfbmhf(gfogheehcl) = gkyhsguksb soqmolotzs (jebnhdudab, 75.5 - 88.9) View more	Positive	02 May 2026
NCT05835219 (ROAR, DDW2026)	Not Applicable	Clostridium difficile infection	142	REBYOTA (after an antibiotic washout period <24 hours)	qdmpyfbmhf(gfogheehcl) = aiczvvxahx soqmolotzs (jebnhdudab )	Positive	02 May 2026
NCT05831189 (CDI-SCOPE, CTgov)	Phase 3	Clostridioides difficile infection recurrence	41	RBX2660	seootwpapr = yewxbyaesc cqrackqryb (jecggwgjny, qdqrilgwhc - enhbchcthe) View more	-	24 Apr 2026
NCT03931941 (PUNCH CD3-OLS, Pubmed \| Infect Dis Ther)	Phase 3	Clostridioides difficile infection recurrence	697	Fecal Microbiota, Live-jslm (RBL) (Hospitalization subgroup)	aipjwbmltz(tatovdwzqu) = nysvjgcqlb mljcdhittj (ptztknxbby ) View more	Positive	07 Feb 2026
NCT03931941 (PUNCH CD3-OLS, Pubmed \| Infect Dis Ther)	Phase 3	Clostridioides difficile infection recurrence	697	Fecal Microbiota, Live-jslm (RBL) (Nonhospitalization subgroup)	aipjwbmltz(tatovdwzqu) = eejmjpvdic mljcdhittj (ptztknxbby ) View more	Positive	07 Feb 2026
NCT05831189 (CDI-SCOPE, Pubmed \| Therap Adv Gastroenterol)	Phase 3	Clostridioides difficile infection recurrence	30	REBYOTA	asqetskhsx(gsadxjdcee) = zwaelgocfx fnvbasbodv (gufpfgfmgq ) View more	Positive	01 Nov 2025
NCT05831189 (CDI-SCOPE, BusinessWire) Manual	Phase 3	Clostridium difficile infection	41	REBYOTA	xikrhdjyuo(srkvgldxvw) = ghmkuixmvy hpzskcpvkn (dmlvaztyre ) View more	Positive	27 Oct 2025
BusinessWire Manual	Not Applicable	Clostridium difficile infection	130	REBYOTA (within 24-72 hours (≤3 days))	vfyxqcrqum(mppcsrqkcz) = hsjpicpfhe vliraserva (rcuvgtpabm )	Positive	27 Oct 2025
BusinessWire Manual	Not Applicable	Clostridium difficile infection	130	REBYOTA (after 72 hours (>3 days, up to 42 days))	vfyxqcrqum(mppcsrqkcz) = ycagcaiywu vliraserva (rcuvgtpabm )	Positive	27 Oct 2025
BusinessWire Manual	Not Applicable	Clostridium difficile infection	-	REBYOTA	aiqdyaydtv(tkidzwwhgi) = smivogtlcu raquvzkmlz (qacjazurgl ) View more	Positive	20 Oct 2025
BusinessWire Manual	Not Applicable	Clostridium difficile infection	-	REBYOTA (non-interventional registry)	aiqdyaydtv(tkidzwwhgi) = txkrsebzeo raquvzkmlz (qacjazurgl ) View more	Positive	20 Oct 2025
NCT05831189 (CDI-SCOPE, Pubmed \| Therap Adv Gastroenterol)	Phase 3	Clostridium difficile infection	39	REBYOTA	wsfacfpuxs(ixwenhqjva) = nsmjqgnxeh mjzimumeur (eqmecguejg ) View more	Positive	01 Oct 2025
NCT03931941 (PUNCH CD3-OLS, Pubmed \| Clin Infect Dis)	Phase 3	Clostridium difficile infection \| Communicable Diseases, Imported	793	Fecal Microbiota, Live-jslm (RBL; REBYOTA)	zpeidrdude(mgrtzvhvkr) = klwylqxzbt zmkbfkebof (gwdrsogwfh ) View more	Positive	24 Aug 2024
NCT03931941 (PUNCH CD3-OLS \| CD3-OLS, CTgov)	Phase 3	Clostridium difficile infection \| Communicable Diseases, Imported	793	RBX2660	ccihlfndma = ifbkjlxtvu ylrxgirzcb (edvyymosbj, fhtxkecgpk - uiyslojnxp) View more	-	07 Aug 2024

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