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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02134392
Recruitment Status : Recruiting
First Posted : May 9, 2014
Last Update Posted : July 7, 2020
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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
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 : January 2022
Estimated Study Completion Date : January 2022

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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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 identifier (NCT number): NCT02134392

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Contact: Ling Fan, MPH 614-722-3412

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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   
Principal Investigator: Jonathan M. Gisser, M.D.         
Sponsors and Collaborators
Jonathan Gisser
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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 Identifier: NCT02134392    
Other Study ID Numbers: IRB12-00691
First Posted: May 9, 2014    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 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
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Jonathan Gisser, Nationwide Children's Hospital:
Clostridium difficile
Fecal Transplant
Fecal Microbiota Transplant
Additional relevant MeSH terms:
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Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses