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

NCT02134392 | Unknown Phase 1 FDA Drug

• 1 other identifier: IRB12-00691
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Resolution of C. difficile

  The primary objective of the study is to establish the cure rate of C. difficile infection in pediatric patients.

  6 months post transplant

Secondary Outcomes (1)

• Adverse events

  Six months post transplant

Study Arms (1)

Fecal Microbiota Transplantation

EXPERIMENTAL

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

Biological: Fecal Microbiota Transplantation

Interventions

Fecal Microbiota Transplantation BIOLOGICAL

250 ml of a fecal suspension diluted in saline will be administered via colonoscopy or enema in patients with recurrent c-diff.

Fecal Microbiota Transplantation

Eligibility Criteria

• Age: 2 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)
• 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)

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Jonathan Gisser: lead

Study Sites (1)

GI Division, Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

RECRUITING

MeSH Terms

Interventions

Fecal Microbiota Transplantation

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Jonathan M. Gisser, M.D.

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ling Fan, MPH

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Faculty

Study Record Dates

• First Submitted: May 7, 2014
• First Posted: May 9, 2014
• Study Start: December 1, 2013
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: September 29, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)