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Fresh Versus Frozen Stool for Fecal Transplant in Children

NCT02423967 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2019-03-06

No results posted yet for this study

Summary

The primary goal of this study will be to assess whether stool collected and frozen from anonymous screened unrelated donors can be as effective as stool freshly collected from recipient's parents when used in Fecal Microbial Transplant for the eradication of recurrent Clostridium difficile infections in children. In the current protocols, which are more than 90% effective, each child who is receiving a fecal transplant has to provide their own donor stool, usually from a parent or close relative. This requires considerable screening costs for each case and is logistically complicated as the donor must be present and must stool just prior to the transplant. The investigators hope to show that a small number of healthy donors can provide stool samples which can be frozen and banked and then thawed for use in numerous patients. The primary goal is to show that Clostridium difficile will be eradicated as effectively (Greater than 90% success) when using the stool from the frozen donors.

The study will also evaluate the inflammatory response and intestinal microbiome in young children aged 1-3 years with Clostridium difficile infections to better predict which ones will respond to fecal transplantation and which ones have incidental infections. For this question the investigators will gather stool samples to check for lactoferrin, calprotectin, and alpha1antitrypsin, and 16s ribosomal RNA analysis in children before and after the fecal transplants. The goal is to see if there is an intestinal microbiome that predisposes some children to getting sick from Clostridium difficile versus just having it incidentally.

Conditions

  • Clostridium Difficile

Interventions

BIOLOGICAL

Transplant uses frozen anonymous stool

The intervention is using frozen anonymous donor stool instead of fresh stool from family members for the fecal microbial transplant to treat recurrent CDI.

BIOLOGICAL

Transplant uses fresh familial stool

The intervention is using fresh familial donor stool for the fecal microbial transplant to treat recurrent CDI

Sponsors & Collaborators

Principal Investigators

  • Mark Bartlett, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2019-03-04
Completion
2019-03-04

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02423967 on ClinicalTrials.gov