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NCT03973697

Penn Microbiome Therapy for Recurrent Clostridium Difficile Infection

Terminated Phase 2 Results posted Last updated 1 November 2023
What this trial tests

Phase 2 trial testing Penn Microbiome Therapy - 001 in Recurrent Clostridium Difficile Infection in 9 participants. Terminated before completion.

Timeline
13 January 2020
Primary endpoint
11 August 2021
31 December 2021

Quick facts

Lead sponsorUniversity of Pennsylvania
PhasePhase 2
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment9
Start date13 January 2020
Primary completion11 August 2021
Estimated completion31 December 2021
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Pennsylvania

Who can join

18 and older, any sex, with Recurrent Clostridium Difficile Infection. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Subjects With Resolution of Symptoms After Treatment With One of the PMT Suite of Products or Control. Primary · 8 weeks

Clinical resolution will be compared by determining the proportion of subjects with clinical resolution of diarrhea without recurrence in subjects with R-CDI at 8 weeks (56 days) following FMT. Clinical resolution will be defined as follows: * ≤ 4 stools per calendar day for the prior two days with no stool of Bristol stool scale type 7 * No additional stool tests with a positive EIA for C. difficile toxin since study enrollment * No additional prescription or use of anti-CDI antibiotics (unless given for prophylaxis) since study enrollment * No need for an additional

GroupValue95% CI
Single Dose of PMT1
Two Doses of PMT2
All-cause Mortality at 30-days Following Last FMT Secondary · 30 days
GroupValue95% CI
Single Dose of PMT0
Two Doses of PMT0
All-cause Mortality at 60-days Following Last FMT Secondary · 60 days
GroupValue95% CI
Single Dose of PMT0
Two Doses of PMT0
Colectomy or Diverting Ileostomy Within 30 Days After Last FMT Secondary · 30 days
GroupValue95% CI
Single Dose of PMT0
Two Doses of PMT0
Cumulative Days of Hospitalization From Enrollment Until 30 Days After FMT Secondary · 30 days
GroupValue95% CI
Single Dose of PMT105 – 16
Two Doses of PMT11 – 1.5
Cumulative Days in Intensive Care Unit From Enrollment Until 30 Days After Last FMT Secondary · 30 Days
GroupValue95% CI
Single Dose of PMT00 – 0
Two Doses of PMT00 – 0
Bacteremia From Enrollment Until 30 Days After Last FMT Secondary · 30 days
GroupValue95% CI
Single Dose of PMT1
Two Doses of PMT0
Hospital Admission Within 60 Days of Discharge From Index Hospitalization Secondary · 60 days
GroupValue95% CI
Single Dose of PMT3
Two Doses of PMT1

Adverse events — posted to ClinicalTrials.gov

Time frame: 6 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Single Dose of PMT
Serious: 3/5 (60%)
Deaths: 0/5
Two Doses of PMT
Serious: 3/4 (75%)
Deaths: 0/4

Serious adverse events (15 terms)

ReactionSystemSingle Dose of PMTTwo Doses of PMT
SepsisInfections and infestations——
Acute kidney injuryRenal and urinary disorders——
AnemiaBlood and lymphatic system disorders——
Cognitive disturbanceNervous system disorders——
ColitisGastrointestinal disorders——
DiahrrheaGastrointestinal disorders——
DyspneaRespiratory, thoracic and mediastinal disorders——
EnterocolitisGastrointestinal disorders——
Gastrointestinal disorders-otherGastrointestinal disorders——
Gastrointestinal disorders-otherGastrointestinal disorders——
HyponatremiaMetabolism and nutrition disorders——
HypotensionVascular disorders——
Lung infectionInfections and infestations——
Peritoneal infectionInfections and infestations——
Surgical and medical procedures-otherSurgical and medical procedures——
Other adverse events (53 terms — click to expand)

ReactionSystemSingle Dose of PMTTwo Doses of PMT
DiarrheaGastrointestinal disorders——
NauseaGastrointestinal disorders——
DyspneaRespiratory, thoracic and mediastinal disorders——
Abdominal painGastrointestinal disorders——
AscitesGastrointestinal disorders——
BloatingGastrointestinal disorders——
FlatulenceGastrointestinal disorders——
Gastroesophageal reflux diseaseGastrointestinal disorders——
HeadacheNervous system disorders——
Acute kidney injuryRenal and urinary disorders——
HypertensionVascular disorders——
HypotensionVascular disorders——
AnemiaBlood and lymphatic system disorders——
Blood and lymphatic system disorders-otherBlood and lymphatic system disorders——
Blood and lymphatic system disorders-otherBlood and lymphatic system disorders——
LeukocytosisBlood and lymphatic system disorders——
Abdominal distensionGastrointestinal disorders——
BelchingGastrointestinal disorders——
DehydrationGastrointestinal disorders——
DysphagiaGastrointestinal disorders——
EnterocolitisGastrointestinal disorders——
EpistaxisGastrointestinal disorders——
Gastrointestinal disorders-otherGastrointestinal disorders——
Rectal painGastrointestinal disorders——
VomitingGastrointestinal disorders——
Herpes simplex reactivationInfections and infestations——
Urinary tract infectionInfections and infestations——
Alkaline phosphatase increasedInvestigations——
Investigations-OtherInvestigations——
Investigations-otherInvestigations——
Lipase increasedInvestigations——
Platelet count decreasedInvestigations——
Weight gainInvestigations——
Weight lossInvestigations——
HyperkalemiaMetabolism and nutrition disorders——
Neoplasms benign, malignant and unspecified (incl cysts and polyps)-otherNeoplasms benign, malignant and unspecified (incl cysts and polyps)——
LethargyNervous system disorders——
SyncopeNervous system disorders——
TremorNervous system disorders——
Renal and urinary disorders-OtherRenal and urinary disorders——

Most-reported serious reactions: Sepsis, Acute kidney injury, Anemia, Cognitive disturbance, Colitis, Diahrrhea, Dyspnea, Enterocolitis.

Data from ClinicalTrials.gov NCT03973697 adverse events section.

Sponsor's own description

This is a randomized, open label, comparative, Phase II study to determine which dose of fecal microbiota transplant using Penn Microbiome Therapy (PMT) products is most effective in treating and preventing recurrence of Clostridium difficile infection (C diff).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. The development of live biotherapeutics against <i>Clostridioides difficile</i> infection towards reconstituting gut microbiota.
    Zhang Y, Saint Fleur A, Feng H. · · 2022 · cited 23× · PMID 35319337 · DOI 10.1080/19490976.2022.2052698
  2. Frontiers in antibiotic alternatives for <i>Clostridioides difficile</i> infection.
    Phanchana M, Harnvoravongchai P, Wongkuna S, Phetruen T, et al · · 2021 · cited 12× · PMID 34876784 · DOI 10.3748/wjg.v27.i42.7210

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing