Fecal microbiota
Identification
- Summary
Fecal microbiota is a bacterial suspension manufactured from human fecal matter used to prevent the recurrence of Clostridioides difficile infection.
- Brand Names
- Rebyota, VOWST
- Generic Name
- Fecal microbiota
- DrugBank Accession Number
- DB17743
- Background
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.4,5,6 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.1,4
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.3 The purpose of fecal microbiota transplantation is to restore gut microbiota and replace microbes with healthy host microbiota.2
REBYOTA, a live fecal microbiota suspension for rectal use, was approved by the FDA in November 2022.5,7 In April 2023, the agency also approved VOWST, a capsule formulation of live fecal microbiota spores for oral administration.6,8
- Type
- Biotech
- Groups
- Approved, Investigational
- Biologic Classification
- Protein Based Therapies
Other protein based therapies - Protein Chemical Formula
- Not Available
- Protein Average Weight
- Not Available
- Sequences
- Not Available
- Synonyms
- Donor human stool
- Donor human stool spores (ethanol treated)
- Fecal microbiota spores, live-brpk
- Live fecal microbiota
- Live fecal microbiota spores
Pharmacology
- 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.5,6
Reduce drug development failure ratesBuild, train, & validate machine-learning modelswith evidence-based and structured datasets.Build, train, & validate predictive machine-learning models with structured datasets.- Associated Conditions
Indication Type Indication Combined Product Details Approval Level Age Group Patient Characteristics Dose Form Prevention of Clostridioides difficile infection recurrence •••••••••••• •••••••••• Prevention of Clostridioides difficile infection recurrence •••••••••••• ••••••• - Contraindications & Blackbox Warnings
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- Pharmacodynamics
Since fecal microbiota products are manufactured from human fecal matter, their use may carry a risk of transmitting infectious agents and contain food allergens.5,6 There is also a risk of developing an acute anaphylactic reaction for fecal microbiota directed for rectal use.5
- Mechanism of action
The mechanism of action of fecal microbiota has not been established.5,6 In the prevention of the recurrence of Clostridioides difficile infection (CDI), it is possible that the reintroduction of normal flora from donors corrects the intestinal imbalance of microorganisms. Antibiotics, such as clindamycin, are used in the treatment of CDI; however, they can also lead to a chronic and contagious condition characterized by low phylotypic diversity, the presence of opportunistic pathogens, the upregulation of pro-inflammatory genes and the reduction of colon nutrients. The use of fecal microbiota transplantations increases the diversity of fecal microbiota as well as the proportion of "beneficial" bacteria.1
- Absorption
Not available.
- Volume of distribution
Not available.
- Protein binding
Not available.
- Metabolism
Not available.
- Route of elimination
Not available.
- Half-life
Not available.
- Clearance
Not available.
- Adverse Effects
- Improve decision support & research outcomesWith structured adverse effects data, including: blackbox warnings, adverse reactions, warning & precautions, & incidence rates. View sample adverse effects data in our new Data Library!Improve decision support & research outcomes with our structured adverse effects data.
- Toxicity
Toxicity information regarding fecal microbiota is not readily available. Patients experiencing an overdose are at an increased risk of severe adverse effects such as acute allergic reactions.5 Symptomatic and supportive measures are recommended.
- Pathways
- Not Available
- Pharmacogenomic Effects/ADRs
- Not Available
Interactions
- Drug Interactions
- This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.
Drug Interaction Integrate drug-drug
interactions in your softwareAcetic acid The therapeutic efficacy of Fecal microbiota can be decreased when used in combination with Acetic acid. Acetyl sulfisoxazole The therapeutic efficacy of Fecal microbiota can be decreased when used in combination with Acetyl sulfisoxazole. Amikacin The therapeutic efficacy of Fecal microbiota can be decreased when used in combination with Amikacin. Aminosalicylic acid The therapeutic efficacy of Fecal microbiota can be decreased when used in combination with Aminosalicylic acid. Amoxicillin The therapeutic efficacy of Fecal microbiota can be decreased when used in combination with Amoxicillin. - Food Interactions
- Take on an empty stomach. For the oral administration of fecal microbiota spore capsules, each dose should be taken on an empty stomach prior to the first meal of the day.
Products
- Drug product information from 10+ global regionsOur datasets provide approved product information including:dosage, form, labeller, route of administration, and marketing period.Access drug product information from over 10 global regions.
- International/Other Brands
- REBYOTA (Rebiotix, Inc.) / VOWST (Seres Therapeutics, Inc.)
- Brand Name Prescription Products
Name Dosage Strength Route Labeller Marketing Start Marketing End Region Image Rebyota Suspension 50000000000 [CFU]/150mL Rectal Ferring Pharmaceuticals Inc. 2023-01-09 Not applicable US Vowst Capsule 30000000 [CFU]/1 Oral Aimmune Therapeutics, Inc. 2023-04-26 Not applicable US
Categories
- Drug Categories
- Chemical TaxonomyProvided by Classyfire
- Description
- Not Available
- Kingdom
- Organic Compounds
- Super Class
- Organic Acids
- Class
- Carboxylic Acids and Derivatives
- Sub Class
- Amino Acids, Peptides, and Analogues
- Direct Parent
- Peptides
- Alternative Parents
- Not Available
- Substituents
- Not Available
- Molecular Framework
- Not Available
- External Descriptors
- Not Available
- Affected organisms
- Humans and other mammals
Chemical Identifiers
- UNII
- Q805XO2F7C
- CAS number
- Not Available
References
- General References
- Brown WR: Fecal microbiota transplantation in treating Clostridium difficile infection. J Dig Dis. 2014 Aug;15(8):405-8. doi: 10.1111/1751-2980.12160. [Article]
- Chopra T, Hecht G, Tillotson G: Gut microbiota and microbiota-based therapies for Clostridioides difficile infection. Front Med (Lausanne). 2023 Jan 9;9:1093329. doi: 10.3389/fmed.2022.1093329. eCollection 2022. [Article]
- Yang R, Chen Z, Cai J: Fecal microbiota transplantation: Emerging applications in autoimmune diseases. J Autoimmun. 2023 Apr 26:103038. doi: 10.1016/j.jaut.2023.103038. [Article]
- Bainum TB, Reveles KR, Hall RG 2nd, Cornell K, Alvarez CA: Controversies in the Prevention and Treatment of Clostridioides difficile Infection in Adults: A Narrative Review. Microorganisms. 2023 Feb 3;11(2):387. doi: 10.3390/microorganisms11020387. [Article]
- FDA Approved Drug Products: REBYOTA (fecal microbiota, live - jslm) suspension for rectal use [Link]
- FDA Approved Drug Products: VOWST (fecal microbiota spores, live-brpk) capsules for oral administration (April 2023) [Link]
- US Food & Drug Administration: FDA Approves First Fecal Microbiota Product [Link]
- Business Wire: Seres Therapeutics and Nestlé Health Science Announce FDA Approval of VOWST (fecal microbiota spores, live-brpk) for Prevention of Recurrence of C. difficile Infection in Adults Following Antibacterial Treatment for Recurrent CDI [Link]
- External Links
- 2636536
- Wikipedia
- Fecal_microbiota
Clinical Trials
- Clinical Trials
Phase Status Purpose Conditions Count 4 Completed Treatment Bacterial Peritonitis / Faeces Smearing / Microbial Colonization 1 4 Completed Treatment Clostridium Difficile Infection (CDI) 1 4 Recruiting Treatment Ulcerative Colitis 1 4 Unknown Status Treatment Ulcerative Colitis 1 3 Active Not Recruiting Treatment Irritable Bowel Syndrome (IBS) 1
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Not Available
- Dosage Forms
Form Route Strength Suspension Rectal 50000000000 [CFU]/150mL Capsule Oral 30000000 [CFU]/1 - Prices
- Not Available
- Patents
- Not Available
Properties
- State
- Not Available
- Experimental Properties
- Not Available
Drug created at May 03, 2023 16:55 / Updated at October 05, 2023 17:34