Fresh Versus Frozen Stool for Fecal Transplant in Children

NCT02423967 | Completed Phase 1

• 1 other identifier: 14-004472
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Clostridium difficile (CD) Eradication; percentage of patients with negative CD toxin in stool following Fecal Microbiota Transplant

  Will analyze stool sample collected 4 weeks after fecal microbiota transplant (FMT) for presence or absence of Clostridium difficile toxin. In addition, will note whether presenting symptoms improved or not after FMT.

  4 weeks

Secondary Outcomes (3)

• Changes in quality of life questionnaire scores after Fecal Microbiota Transplant

  12 weeks

• percentage of patients with stool Calprotectin levels exceeding 50 mcg/g after Fecal Microbiota Transplant

  4 weeks

• percentage of patients with positive Lactoferrin inflammatory marker in stools after Fecal Microbiota Transplant

  4 weeks

Study Arms (2)

Transplant uses fresh familial stool

ACTIVE COMPARATOR

Undergoes Fecal Microbial Transplant using fresh stool from a screened family member Followed up and assessed for eradication of Clostridium difficile Quality of life assessed Stool assessed for inflammation and microbiome

Biological: Transplant uses fresh familial stool

Transplant uses frozen anonymous stool

EXPERIMENTAL

Undergoes Fecal Microbial Transplant using stool collected from screened anonymous donor that has been frozen until time of Fecal Microbial Transplant Followed up and assessed for eradication of Clostridium difficile Quality of life assessed Stool assessed for inflammation and microbiome

Biological: Transplant uses frozen anonymous stool

Interventions

Transplant uses frozen anonymous stool BIOLOGICAL

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

Also known as: fecal microbial transplant

Transplant uses frozen anonymous stool

Transplant uses fresh familial stool BIOLOGICAL

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

Also known as: fecal microbila transplant

Transplant uses fresh familial stool

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Age under 1 or over 18
• No diarrhea

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Study Officials

• Mark Bartlett, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: April 6, 2015
• First Posted: April 22, 2015
• Study Start: April 1, 2015
• Primary Completion: March 4, 2019
• Study Completion: March 4, 2019
• Last Updated: March 6, 2019

Record last verified: 2019-03

Locations

US (1)