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Penn Microbiome Therapy for Recurrent Clostridium Difficile Infection

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ClinicalTrials.gov Identifier: NCT03973697
Recruitment Status : Recruiting
First Posted : June 4, 2019
Last Update Posted : December 3, 2020
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Recurrent Clostridium Difficile Infection Drug: Penn Microbiome Therapy - 001 Drug: Penn Microbiome Therapy - 002 Drug: Penn Microbiome Therapy - 003 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, open label, comparative
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Randomized Trial to Evaluate the Optimal Dosing of Fecal Microbiota Transplantation Using the Penn Microbiome Therapy Products for Recurrent Clostridium Difficile Infection
Actual Study Start Date : January 13, 2020
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Arm Intervention/treatment
Experimental: Single dose of PMT Drug: Penn Microbiome Therapy - 001
Fecal Microbiota for Transplant, enema product
Other Name: PMT-001

Drug: Penn Microbiome Therapy - 002
Fecal Microbiota for Transplant, suspension product
Other Name: PMT-002

Drug: Penn Microbiome Therapy - 003
Fecal Microbiota for Transplant, capsule product
Other Name: PMT-003

Experimental: Two doses of PMT
Administered within 24 hours
Drug: Penn Microbiome Therapy - 001
Fecal Microbiota for Transplant, enema product
Other Name: PMT-001

Drug: Penn Microbiome Therapy - 002
Fecal Microbiota for Transplant, suspension product
Other Name: PMT-002

Drug: Penn Microbiome Therapy - 003
Fecal Microbiota for Transplant, capsule product
Other Name: PMT-003




Primary Outcome Measures :
  1. Number of subjects with resolution of symptoms after treatment with one of the PMT suite of products or control. [ Time Frame: 8 weeks ]
    Clinical outcome 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.


Secondary Outcome Measures :
  1. Number of subjects with resolution of symptoms in relation to the amount of drug product administered versus the quantitative culture the drug product. [ Time Frame: 8 weeks ]
  2. Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE V5.0 [ Time Frame: 180 Days ]
  3. Frequency of solicited adverse events (AEs) as assessed by CTCAE V5.0 [ Time Frame: 180 Days ]
  4. Frequency of serious adverse events (SAEs) as assessed by CTCAE V5.0 [ Time Frame: 180 Days ]
  5. Frequency of AEs of special interest (AESIs) as assessed by CTCAE V5.0 [ Time Frame: 180 Days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Second or greater episode of CDI (first or greater recurrence) within 12 months, with symptoms including bowel movement altered in frequency or consistency from baseline.
  2. Stool positive for C. difficile toxin by EIA or toxin gene by NAAT within 60 days of enrollment.
  3. At least one additional prior positive stool test for C. difficile within the prior 12 months (EIA or NAAT as above).
  4. Age ≥ 18 years.
  5. Minimum of 72 hours of receipt of standard-of-care (vancomycin or fidaxomicin) antibiotic treatment for R-CDI prior to intervention.

Exclusion Criteria:

  1. Evidence of colon/small bowel perforation at the time of study screening
  2. Goals of care are directed to comfort rather than curative measures.
  3. Moderate (ANC < 1000 cells/uL) or severe (ANC < 500 cells/uL) neutropenia.
  4. Known food allergy that could lead to anaphylaxis.
  5. Pregnancy

    a. For subjects of childbearing potential (ages 18 to 55), the subject must have a negative urine pregnancy test within 48 hours of consent and no more than 48 hours prior to first product administration

  6. Meeting criteria for severe, severe-complicated/fulminant CDI within 24 hours of planned trial enrollment. We define severe or severe-complicated/fulminant CDI as any one of the following: (1) leukocytosis with peripheral WBC ≥ 15,000 cells/mL; (2) hypotension with systolic blood pressure sustained < 90mmHg for three or more hours or requiring pressors; (3) provider documentation of ileus or radiologic evidence of bowel dilation or megacolon; (4) acute kidney injury with increase in baseline serum creatinine level by ≥50% or new dialysis initiation; (5) serum lactate > 2.2 mmol/L; or (6) ≥ 3 systemic inflammatory response syndrome (SIRS) criteria (which include heart rate > 90 beats per minute, respiratory rate > 20 breaths per minute or PaCO2 < 32 mmHg, temperature >38ºC or <36ºC, WBC > 12,000 cells/uL, <4,000 cells/uL, or >10% immature (band) forms).
  7. Receipt of FMT or enrollment in a clinical trial for FMT within the last 3 months.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03973697


Contacts
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Contact: Brenden J Kelly, MD, MS (215) 662-6932 brendank@pennmedicine.upenn.edu
Contact: Lauren Dutcher, MD (215) 662-6932 dutcherl@pennmedicine.upenn.edu

Locations
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United States, Pennsylvania
Hospital of the Univeristy of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Brendan J Kelly, MD, MS    215-662-6932    brendank@pennmedicine.upenn.edu   
Contact: Lauren Dutcher, MD    2156626932    dutcherl@pennmedicine.upenn.edu   
Sponsors and Collaborators
University of Pennsylvania
Investigators
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Principal Investigator: Ebbing Lautenbach, MD, MPH, MSCE University of Pennsylvania
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03973697    
Other Study ID Numbers: IRB # 832963
First Posted: June 4, 2019    Key Record Dates
Last Update Posted: December 3, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Clostridium Infections
Enterocolitis, Pseudomembranous
Gram-Positive Bacterial Infections
Bacterial Infections
Enterocolitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases