Fecal microbiota

Overview

Fecal microbiota, given either as a rectal transplant or in an oral formulation of live spores, is an FDA-approved option to prevent the recurrence of Clostridioides difficile infection (CDI) in patients given an antibacterial treatment for recurrent CDI. Although the incidence of CDI has declined and the number of cases requiring hospitalization has been lower over the years, the recurrence of CDI still represents a challenge. Recurrent CDI has a high risk of mortality and a high failure rate. The use of fecal microbiota transplantation is a treatment alternative for patients with recurrent CDI, also associated with lower costs and patient waiting times. For this type of therapy to be efficient, qualified donors must be selected. Human fecal matter is then tested for a panel of transmissible pathogens and processed with methods aimed at preserving bacterial viability. The purpose of fecal microbiota transplantation is to restore gut microbiota and replace microbes with healthy host microbiota. REBYOTA, a live fecal microbiota suspension for rectal use, was approved by the FDA in November 2022. In April 2023, the agency also approved VOWST, a capsule formulation of live fecal microbiota spores for oral administration.

Indication

Fecal microbiota is indicated for the prevention of recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older, following antibiotic treatment for recurrent CDI.

Associated Conditions

Clostridioides Difficile Infection Recurrence

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
The Safety and Efficacy of FMT in Patients With CID	2023/06/23	NCT05917379	Phase 1	Recruiting	Peking University Sixth Hospital
Fecal Microbiota Transplantation as a Treatment for Ulcerative Colitis	2020/06/17	NCT04434872	Phase 2	Terminated	Tel-Aviv Sourasky Medical Center
Low Sulfur Fecal Transplant for Ulcerative Colitis	2019/05/14	NCT03948919	Phase 1	Completed	University of Minnesota
Fecal Microbiota Transplantation for Constipation	2017/10/12	NCT03308461	Not Applicable	Completed	The Second Hospital of Nanjing Medical University
Fecal Microbiota Transplantation in Depression	2017/09/13	NCT03281044	Phase 2	Terminated	Psychiatric Hospital of the University of Basel
Fecal Microbial Transplantation in Relapsing Multiple Sclerosis Patients	2017/06/12	NCT03183869	Phase 2	Terminated	Lawson Health Research Institute
FMT in Gut aGVHD Treated	2017/05/11	NCT03148743	N/A	Recruiting	The First Affiliated Hospital of Soochow University
Fecal Microbiota Transplantation for Epilepsy	2016/09/05	NCT02889627	Phase 2	Recruiting	The Second Hospital of Nanjing Medical University
Fecal Microbiota Transplantation in HIV	2014/10/03	NCT02256592	Phase 1	Completed	University of California, San Francisco

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
VOWST	Aimmune Therapeutics, Inc.	71881-400	ORAL	30000000 [CFU] in 1 1	4/21/2023
Rebyota	Ferring Pharmaceuticals Inc.	55566-9800	RECTAL	50000000000 [CFU] in 150 mL	11/30/2022

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Related News

Fecal Microbiota Therapy Shows 95% Success Rate in Preventing Recurrent C. difficile Infection

2 months ago

Phase 3b trial demonstrates colonoscopic administration of Rebyota (fecal microbiota live-jslm) achieves 95.1% treatment success in preventing recurrent C. difficile infection with minimal adverse events.

Phase 3b Trial Shows Colonoscopic Administration of Rebyota Effective for Preventing Recurrent C. difficile Infection

2 months ago

A phase 3b clinical trial demonstrated that Rebyota (fecal microbiota, live-jslm) administered via colonoscopy achieved a 95.1% treatment success rate in preventing recurrent C. difficile infection.

Novel Fecal Microbiota Pill Enters Clinical Trial for Advanced Pancreatic Cancer Treatment

4 months ago

Canadian researchers launch Phase 1 trial of LND101, an oral fecal transplant therapy, targeting pancreatic cancer's dismal 10% five-year survival rate.

Advancements in Clostridioides difficile Treatment and Prevention Highlighted in 2024

7 months ago

• Real-world data presented at ID Week 2024 confirms the continued efficacy and safety of Rebyota, a live biotherapeutic product, for recurrent Clostridioides difficile infection (rCDI) two years post-approval. • Research indicates reduced vancomycin susceptibility in Clostridioides difficile isolates correlates with diminished sustained clinical response, emphasizing the need for alternative treatment strategies. • Vedanta Biosciences has commenced a Phase 3 clinical trial (RESTORATiVE303) evaluating VE303, a live biotherapeutic product, for preventing recurrent Clostridioides difficile infection (rCDI). • A study showed that oral vancomycin prophylaxis significantly reduces Clostridioides difficile infection incidence during hospitalization for autologous stem cell transplant recipients.

FDA-Approved Vowst Offers Novel Treatment Approach for Recurrent C. difficile Infections

7 months ago

Vowst represents a significant advancement in treating recurrent C. difficile infections, offering a novel oral microbiome therapeutic approach that differs from traditional antibiotics.

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