Recruiting
Phase 1

Fecal Transplant

Sponsor:

Jonathan Gisser

Code:

NCT02134392

Conditions

Clostridium Difficile

Eligibility Criteria

Sex: All

Age: 2 - 21

Healthy Volunteers: Not accepted

Interventions

Fecal Microbiota Transplantation

Study Details

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.

Conditions

Clostridium Difficile

Study ID

NCT02134392

Start date

Dec, 2013

Status verified date

Sep, 2023

Completion date

Jan, 2025

Anticipated

Primary completion date

Jan, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 21

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Fecal Microbiota Transplantation

250 ml of a fecal suspension diluted in saline given by colonoscopy or enema.

Interventions

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 measure

  • Resolution of C. difficile [ Time Frame: 6 months post transplant ]

Central Contacts and Locations

Central contacts

Ling Fan, MPH

614-722-3412ling.fan@nationwidechildrens.org

Locations

GI Division, Nationwide Children's Hospital

Recruiting

Columbus, Ohio, United States, 43205

Contacts

Jonathan M. Gisser, M.D.

614-355-2858jonathan.gisser@nationwidechildrens.org

Principal Investigator:

Jonathan M. Gisser, M.D.

More Information

Sponsor

Jonathan Gisser

Last update posted

Sep 29, 2023

Last verified

Sep, 2023

Keywords

  • C-diff
  • Clostridium difficile
  • Fecal Transplant
  • FMT
  • Fecal Microbiota Transplant

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Jonathan Gisser on 2023-09-29.