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Fecal Transplant for Pediatric Patients Who Have Recurrent C-diff Infection (FMT)

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ClinicalTrials.gov Identifier: NCT02134392
Recruitment Status : Recruiting
First Posted : May 9, 2014
Last Update Posted : August 2, 2018
Sponsor:
Information provided by (Responsible Party):
Jonathan Gisser, Nationwide Children's Hospital

Brief Summary:

C-diff infection often causes belly pain and diarrhea and can be very hard to treat with medicine. One of the possible reasons that C-diff infection is hard to treat is because there is too much "bad" bacteria in the colon. Investigators believe that putting more "good" bacteria into the colon will help fight the "bad" bacteria. We do this by doing a fecal (poop) transplant.

Fecal transplant has been done at other hospitals, but not at Nationwide Children's Hospital. Since our Investigators have not done this before, this study will help us learn the best way to do the transplant. Investigators also believe this transplant might help improve symptoms for patients with C-diff.


Condition or disease Intervention/treatment Phase
Clostridium Difficile Biological: Fecal Microbiota Transplantation Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fecal Microbiota Transplantation (FMT) for Recurrent or Refractory C. Difficile Infection (CDI) in Pediatric and Young Adult Patients
Study Start Date : December 2013
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arm Intervention/treatment
Experimental: Fecal Microbiota Transplantation
250 ml of a fecal suspension diluted in saline given by colonoscopy or enema.
Biological: Fecal Microbiota Transplantation
250 ml of a fecal suspension diluted in saline will be administered via colonoscopy or enema in patients with recurrent c-diff.




Primary Outcome Measures :
  1. Resolution of C. difficile [ Time Frame: 6 months post transplant ]
    The primary objective of the study is to establish the cure rate of C. difficile infection in pediatric patients.


Secondary Outcome Measures :
  1. Adverse events [ Time Frame: Six months post transplant ]
    Follow up phone calls will be made at days 1, 7, 14, and months 1 and 6 to determine whether adverse events have occurred.



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Ages Eligible for Study:   2 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Recipient inclusion criteria:

  • Documented laboratory-confirmed clostridium difficile infection
  • Documentation of ongoing diarrhea at time of recruitment
  • Children ≥2 years old, <18 years old; young adults >18 years old, <21 years old
  • Undergoing clinically-indicated colonoscopy
  • Recurrent c-diff infection (three or more occurrences)

Donor inclusion criteria:

  • First-degree relative recommended, but not compulsory
  • ≥ 18 years old
  • In good health
  • No antibiotic use within the last 90 days
  • In "low risk" category on modified DHQ (See above)

Exclusion Criteria:

  • Recipient exclusion criteria
  • Severe comorbid condition (at discretion of the principal investigator)
  • On immunosuppressive medications (high dose steroids 30 mg/kg of methylprednisolone)
  • Severe or fulminant C. difficile colitis

    • Toxic appearance
    • Signs of hemodynamic instability
    • Peritoneal signs on physical exam
    • Anemia on complete blood count
    • electrolyte imbalances on basic metabolic panel
  • Considerations for Increased Risk of Adverse Events Should Be Given to patients with decompensated liver cirrhosis, advanced HIV/acquired immune deficiency syndrome, recent bone marrow transplant, or other cause of severe immunodeficiency.
  • History of severe anaphylactic shock

Donor exclusion criteria:

  • Abnormal stools
  • Abdominal complaints
  • History of inflammatory bowel disease or gastrointestinal malignancy
  • Symptoms indicative of irritable bowel syndrome or other chronic pain syndromes (e.g. chronic fatigue syndrome, fibromyalgia)
  • History of systemic autoimmunity (e.g. multiple sclerosis, connective tissue disease)
  • Recent use of potent immunosuppressive medications (calcineurin inhibitors, exogenous glucocorticoids, biological agents, etc..)
  • Recent ingestion of a potential allergen (e.g. nuts) where recipient has a known allergy to this (these) agent(s)
  • Known communicable disease
  • Neurologic, neurodevelopmental or neurodegenerative disorders
  • History of malignancy
  • Has consumed any foods/medications to which the recipient is allergic within the designated period of time

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): NCT02134392


Contacts
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Contact: Ling Fan, MPH 614-722-3412 ling.fan@nationwidechildrens.org

Locations
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United States, Ohio
GI Division, Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Jonathan M. Gisser, M.D.    614-355-2858    jonathan.gisser@nationwidechildrens.org   
Principal Investigator: Jonathan M. Gisser, M.D.         
Sponsors and Collaborators
Jonathan Gisser
Investigators
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Principal Investigator: Jonathan M. Gisser, M.D. Nationwide Children's Hospital

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Responsible Party: Jonathan Gisser, Faculty, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT02134392     History of Changes
Other Study ID Numbers: IRB12-00691
First Posted: May 9, 2014    Key Record Dates
Last Update Posted: August 2, 2018
Last Verified: August 2018
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
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Jonathan Gisser, Nationwide Children's Hospital:
C-diff
Clostridium difficile
Fecal Transplant
FMT
Fecal Microbiota Transplant

Additional relevant MeSH terms:
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Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections