NAV

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
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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

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Associated Conditions
Indication TypeIndicationCombined Product DetailsApproval LevelAge GroupPatient CharacteristicsDose Form
Prevention ofClostridioides difficile infection recurrence••••••••••••••••••••••
Prevention ofClostridioides 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
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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.
DrugInteraction
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interactions in your software
Acetic acidThe therapeutic efficacy of Fecal microbiota can be decreased when used in combination with Acetic acid.
Acetyl sulfisoxazoleThe therapeutic efficacy of Fecal microbiota can be decreased when used in combination with Acetyl sulfisoxazole.
AmikacinThe therapeutic efficacy of Fecal microbiota can be decreased when used in combination with Amikacin.
Aminosalicylic acidThe therapeutic efficacy of Fecal microbiota can be decreased when used in combination with Aminosalicylic acid.
AmoxicillinThe 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

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International/Other Brands
REBYOTA (Rebiotix, Inc.) / VOWST (Seres Therapeutics, Inc.)
Brand Name Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
RebyotaSuspension50000000000 [CFU]/150mLRectalFerring Pharmaceuticals Inc.2023-01-09Not applicableUS flag
VowstCapsule30000000 [CFU]/1OralAimmune Therapeutics, Inc.2023-04-26Not applicableUS flag

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
  1. 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]
  2. 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]
  3. 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]
  4. 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]
  5. FDA Approved Drug Products: REBYOTA (fecal microbiota, live - jslm) suspension for rectal use [Link]
  6. FDA Approved Drug Products: VOWST (fecal microbiota spores, live-brpk) capsules for oral administration (April 2023) [Link]
  7. US Food & Drug Administration: FDA Approves First Fecal Microbiota Product [Link]
  8. 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]
RxNav
2636536
Wikipedia
Fecal_microbiota

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
4CompletedTreatmentBacterial Peritonitis / Faeces Smearing / Microbial Colonization1
4CompletedTreatmentClostridium Difficile Infection (CDI)1
4RecruitingTreatmentUlcerative Colitis1
4Unknown StatusTreatmentUlcerative Colitis1
3Active Not RecruitingTreatmentIrritable Bowel Syndrome (IBS)1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage Forms
FormRouteStrength
SuspensionRectal50000000000 [CFU]/150mL
CapsuleOral30000000 [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