Clostridium difficile colitis

Summary

Clostridium difficile colitis (MONDO:0000705) is a disease and 175 clinical trials. Top therapeutic interventions include fidaxomicin, vancomycin, and bezlotoxumab. A subtype of bacterial infectious disease — broader associated-gene and molecular evidence is on the parent page (see Disease family below).

At a glance

• Clinical trials: 175

Clinical features

No curated clinical features (Orphanet) for this disease.

Identifiers

Disease identifiers

Field	Value
Canonical name	Clostridium difficile colitis
Mondo ID	MONDO:0000705
MeSH	D004761
DOID	DOID:0060185
NCIT	C35286
SNOMED CT	423590009
UMLS	C0238106
MedGen	65946
MedDRA	10009657
Is cancer (heuristic)	no

Also known as: C. diff colitis · C. diff infection · Clostridioides difficile caused colitis (disease) · Clostridioides difficile colitis (disease) · Clostridium difficile infection · pseudomembranous colitis

Disease family

This is a subtype of bacterial infectious disease. Genetic, therapeutic, and trial evidence is largely curated at the broader-term level — see the parent page for the associated-gene cohort and molecular evidence.

Classification path: disease › human disease › disease by etiologic mechanism › disease of primarily extrinsic mechanism › infectious disease › bacterial infectious disease › Clostridium difficile colitis

Related subtypes (51): primary bacterial infectious disease, commensal bacterial infectious disease, opportunistic bacterial infectious disease, chorioamnionitis, bacterial gastritis, bacterial arthritis, bacterial pneumonia, Whipple disease, Aeromonas hydrophila infectious disease, Pectobacterium carotovorum infection, Pseudomonas infection, septic peritonitis, bacterial infectious disease with sepsis, empyema, bacterial urinary tract infection, bacterial sexually transmitted disease, meningococcal infection, pasteurellosis, peritonsillar abscess, pneumonic pasteurellosis, tracheitis, Actinobacillus infectious disease, bacterial conjunctivitis, bacterial endocarditis, bacterial meningitis, Bifidobacteriales infectious disease, haemophilus infectious disease, Proteus infectious disease, pulpitis, rat-bite fever, Rickettsiosis, vibrio infectious disease, Yersinia infectious disease, bacterial myositis, noma, idiopathic severe pneumococcemia, necrotizing soft tissue infection, mycobacterial infectious disease, escherichia coli infection, gram-negative bacterial infections, gram-positive bacterial infections, spirochaetales infections, skin disease caused by bacterial infection, staphylococcal infection, anaerobic bacteria infectious disease, Klebsiella infectious disease, fournier gangrene, botryomycosis, bacterial hemorrhagic fever, Mycoplasmoides infection, Enterococcus infectious disease

Genetics & variants

GWAS landscape

No GWAS associations recorded — common-variant (GWAS) studies don’t cover this disease (typical for Mendelian / rare diseases). See the curated gene cohort and Mendelian overlap below.

Variant details and genetic-evidence tiers

No tiered GWAS variants or ClinVar records for this disease.

Genes & proteins

No associated-gene cohort resolved for this disease. Atlas builds the molecular and therapeutic sections — associated genes, protein families, druggability, pathways, interactions, and drug associations — by aggregating over a disease’s associated genes (resolved via GWAS / GenCC / ClinVar / CIViC), and none resolved here. This is expected for antibody-mediated, autoimmune, or otherwise non-gene-defined conditions; the curated evidence for this disease is its clinical features, GWAS susceptibility, and clinical trials (above).

Function

No pathway enrichment — requires an associated-gene cohort.

Therapeutics

Drugs indicated for this disease

2 approved, 4 in late-stage (phase 3) trials. Disease-direct ChEMBL indications, not inferred from the associated-gene cohort below.

Drug	Development status
Bezlotoxumab	Approved (phase 4)
Clindamycin Phosphate	Approved (phase 4)
Metronidazole	Phase 3 (in late-stage trials)
Nitazoxanide	Phase 3 (in late-stage trials)
Rifampin	Phase 3 (in late-stage trials)
Tolevamer Potassium Sodium	Phase 3 (in late-stage trials)

Clinical trials & evidence

Clinical trials

Clinical trials: 175.

Phase distribution (across all retrieved trials)

Phase	Trials
Not specified	70
PHASE2	34
PHASE3	27
PHASE4	18
PHASE1	15
PHASE2/PHASE3	6
PHASE1/PHASE2	4
EARLY_PHASE1	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT00304863	PHASE4	WITHDRAWN	Addition of Lactobacillus to Metronidazole in Treatment of CDAD
NCT01552668	PHASE4	WITHDRAWN	Fidaxomicin to Prevent Clostridium Difficile Colonization
NCT01630096	PHASE4	UNKNOWN	Clostridial Infection and Oral Lavage -Improving Treatment Before Illness Becomes Severe
NCT01670149	PHASE4	COMPLETED	Rifaximin for Preventing Relapse of Clostridium Associated Diarrhoea
NCT01818141	PHASE4	COMPLETED	Study to Assess Inhibition of Spore Production in Patients With C. Difficile Infections: Fidaxomicin Versus Vancomycin
NCT01972932	PHASE4	TERMINATED	Study of Bio-K+® in the Reduction of the Risk of Clostridium Difficile Infection and Antibiotic Associated Diarrhea
NCT02237859	PHASE4	UNKNOWN	Vancomycin Prophylaxis in Recurrent Clostridium Difficile Infection
NCT02437591	PHASE4	COMPLETED	Study to Evaluate the Pharmacokinetics of Fidaxomicin in Inflammatory Bowel Disease (IBD) Subjects With Clostridium Difficile Infection (CDI)
NCT02464306	PHASE4	WITHDRAWN	Fidaxomicin Versus Standard of Care Therapy in Solid Organ Transplant Recipients With Clostridium Difficile Infection
NCT02692651	PHASE4	COMPLETED	A Comparison of Fidaxomicin and Vancomycin in Patients With CDI Receiving Antibiotics for Concurrent Infections
NCT02951702	PHASE4	COMPLETED	Oral Vancomyin for Primary Clostridium Difficile Infection Prophylaxis in Patients Receiving High-Risk Antibiotics
NCT02996487	PHASE4	COMPLETED	Screening to Prophylax Against Clostridium Difficile Infection -
NCT03200093	PHASE4	TERMINATED	Oral Vancomycin for Preventing Clostridium Difficile Recurrence
NCT03388268	PHASE4	COMPLETED	TOX NEG Trial: Clostridium Difficile Diagnosis and Treatment
NCT03466502	PHASE4	COMPLETED	Oral Vancomycin to Prevent Recurrent C Difficile Infection With Antibiotics
NCT03592082	PHASE4	WITHDRAWN	Use of Bismuth Subsalicylate in Clostridium Difficile Colitis
NCT04000555	PHASE4	TERMINATED	Oral Vancomycin for Secondary Prophylaxis of Clostridium Difficile Infection (CDI)
NCT04090346	PHASE4	COMPLETED	Fecal Microbiota Transplant
NCT06237452	PHASE3	RECRUITING	VE303 for Prevention of Recurrent Clostridioides Difficile Infection
NCT07221370	PHASE2/PHASE3	RECRUITING	Enteral Vancomycin as Primary Prophylaxis Against Clostridioides Difficile Infection in Critically Ill Patients
NCT00106509	PHASE3	COMPLETED	A Study of GT267-004 Versus Vancomycin and GT267-004 Versus Metronidazole in Patients With C.Difficile - Associated Diarrhea
NCT00182429	PHASE3	COMPLETED	Efficacy of Metronidazole Versus Metronidazole and Rifampin in CDAD Treatment
NCT00304356	PHASE3	COMPLETED	Compassionate Use of Nitazoxanide for the Treatment of Clostridium Difficile Infection
NCT01202630	PHASE3	SUSPENDED	BIO-K+ CL1285 for Prevention of Recurrent Clostridium Difficile Infection
NCT01226992	PHASE2/PHASE3	TERMINATED	Oral Vancomycin Followed by Fecal Transplant Versus Tapering Oral Vancomycin
NCT01241552	PHASE3	COMPLETED	A Study of MK-3415, MK-6072, and MK-3415A in Participants Receiving Antibiotic Therapy for Clostridium Difficile Infection (MK-3415A-001)
NCT01295918	PHASE3	COMPLETED	Probiotic Lactobacillus Reuteri to Prevent Antibiotic-associated Diarrhea and Clostridium Difficile-related Infections in Hospitalized Children
NCT01513239	PHASE3	COMPLETED	A Study of MK-6072 and MK-3415A in Participants Receiving Antibiotic Therapy for Clostridium Difficile Infection (MK-3415A-002)
NCT01597505	PHASE3	COMPLETED	Study of CB-183,315 in Participants With Clostridium Difficile Associated Diarrhea (MK-4261-005)
NCT01598311	PHASE3	COMPLETED	A Study of CB-183,315 in Participants With Clostridium Difficile Associated Diarrhea (MK-4261-006)
NCT01887912	PHASE3	TERMINATED	Study of a Candidate Clostridium Difficile Toxoid Vaccine in Subjects at Risk for C. Difficile Infection
NCT01958463	PHASE3	UNKNOWN	Transplantation of Fecal Microbiota for Clostridium Difficile Infection
NCT01983683	PHASE3	COMPLETED	Efficacy and Safety of Cadazolid Versus Vancomycin in Subjects With Clostridium Difficile-associated Diarrhea
NCT01987895	PHASE3	COMPLETED	Efficacy and Safety of Cadazolid Versus Vancomycin in Subjects With Clostridium Difficile - Associated Diarrhea
NCT02301000	PHASE2/PHASE3	TERMINATED	IMT for Primary Clostridium Difficile Infection
NCT02395848	PHASE3	TERMINATED	Efficacy of 30-day Duration of Fidaxomicin for Recurrent C. Difficile Infection
NCT02686645	PHASE2/PHASE3	UNKNOWN	Fecal Microbiota Therapy for Recurrent Clostridium Difficile Infection
NCT02743234	PHASE3	COMPLETED	Fecal Microbiota Transplantation for Relapsing Clostridium Difficile Infection
NCT03005379	PHASE2/PHASE3	TERMINATED	Microbiota or Placebo After Antimicrobial Therapy for Recurrent C. Difficile at Home (MATCH)
NCT03090191	PHASE3	COMPLETED	Clostridium Difficile Vaccine Efficacy Trial

Drugs tested across these trials (top 30)

Molecule	Max phase	Trials referencing
FIDAXOMICIN	4	11
VANCOMYCIN	4	9
BEZLOTOXUMAB	4	5
LOPERAMIDE	4	3
BISMUTH SUBSALICYLATE	4	1
NITAZOXANIDE	4	1
RIFAMPIN	4	1
RIFAXIMIN	4	1
CADAZOLID	3	5
SUROTOMYCIN	3	3
RIDINILAZOLE	3	2
BLOOD, WHOLE	3	1
LACTOBACILLUS ACIDOPHILUS	3	1
MK-3415	3	1
CRS-3123	2	2
IBEZAPOLSTAT	2	1
LFF-571	2	1
MGB-BP-3	2	1
CHEMBL4299436	0	9
17	0	1
6BIO	0	1