Fresh Versus Frozen Stool for Fecal Transplant in Children
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 1 - 18 |
| Updated: | 3/8/2019 |
| Start Date: | April 2015 |
| End Date: | March 4, 2019 |
A Comparison of Efficacy of Fresh Versus Frozen Donor Stool for Fecal Microbial Transplant in Children With Recurrent Clostridium Difficile Infections
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.
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.
The study is designed to enroll forty children aged 1-18 with recurrent Clostridium difficile
Infection (CDI). Recurrent CDI is defined as an infection that persists after three rounds of
appropriate antibiotics. Enrollees will be randomly assigned to receive Fecal Microbial
Transplant using stool from either a screened relative as per current protocols versus using
frozen stool that has been collected from healthy volunteers.
Primary outcome will be the eradication of the Clostridium difficile as defined by
elimination of diarrhea with a negative Clostridium difficile toxin stool test.
Secondary outcomes will include a measure of quality of life pre and post Fecal Microbial
Transplant using a validated quality of life survey instrument, the Health Act Child Health
Questionnaire. The investigators will also assess for inflammation in the stool using
lactoferrin and calprotectin and evaluate the stool microbiome in recipients pre and post
transplant using sequencing to look for any pattern that predicts successful eradication.
Infection (CDI). Recurrent CDI is defined as an infection that persists after three rounds of
appropriate antibiotics. Enrollees will be randomly assigned to receive Fecal Microbial
Transplant using stool from either a screened relative as per current protocols versus using
frozen stool that has been collected from healthy volunteers.
Primary outcome will be the eradication of the Clostridium difficile as defined by
elimination of diarrhea with a negative Clostridium difficile toxin stool test.
Secondary outcomes will include a measure of quality of life pre and post Fecal Microbial
Transplant using a validated quality of life survey instrument, the Health Act Child Health
Questionnaire. The investigators will also assess for inflammation in the stool using
lactoferrin and calprotectin and evaluate the stool microbiome in recipients pre and post
transplant using sequencing to look for any pattern that predicts successful eradication.
Eligible children between aged 1 and 18 years must have had Clostridium difficile infection
that has not been eradicated despite at least two courses of antibiotics ( either
metronidazole or vancomycin).
Inclusion criteria:
- Age 1-18 years
- Diarrhea
- Positive Clostridium difficile infection using stool toxin testing
- Diarrhea that has improved on antibiotics but recurs when antibiotics are stopped.
- Willingness to undergo Fecal Microbial Transplant using frozen stool from anonymous
screened donors.
Exclusion Criteria:
- Age under 1 or over 18
- No diarrhea
We found this trial at
1
site
200 First Street SW
Rochester, Minnesota 55905
Rochester, Minnesota 55905
507-284-2511
Phone: 507-266-0114
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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