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Fecal Microbial Transplant in Pediatric Crohn's Disease (FMTCD)

This study is currently recruiting participants.
See Contacts and Locations
Verified November 2015 by David Suskind, Seattle Children's Hospital
Sponsor:
Information provided by (Responsible Party):
David Suskind, Seattle Children's Hospital
ClinicalTrials.gov Identifier:
NCT02272868
First received: October 16, 2014
Last updated: November 16, 2015
Last verified: November 2015
  Purpose
This is a double blind placebo control trial of fecal microbial transplantation for active Crohn's disease in patients 12 to 21 years of age.

Condition Intervention Phase
Crohn's Disease Biological: Fecal Microbial transplant Drug: Normal Saline Drug: rifaximin+omeprazole+miralax Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Fecal Microbial Transplant in Pediatric Crohn's Disease: A Double Blind Placebo Control Study

Resource links provided by NLM:


Further study details as provided by David Suskind, Seattle Children's Hospital:

Primary Outcome Measures:
  • Pediatric Crohn's Disease Activity Index [ Time Frame: 12 weeks ]

Estimated Enrollment: 32
Study Start Date: January 2015
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fecal microbiome transplant
Pretransplant(Rifaximin 400mg tid x 10 days + omeprazole 20 mg night before transplant and day of transplant + miralax 17g tid x 2 days) + Fecal Microbial Transplant
Biological: Fecal Microbial transplant
Pretransplant regimen(rifaxamin+omeprazole+miralax) + Donor feces transplant
Drug: rifaximin+omeprazole+miralax
Placebo Comparator: Normal saline
Pretransplant(Rifaximin 400mg tid x 10 days + omeprazole 20 mg night before transplant and day of transplant + miralax 17g tid x 2 days) + Normal saline
Drug: Normal Saline
Pretransplant regimen(rifaximin+omeprazole+miralax) +Normal Saline
Drug: rifaximin+omeprazole+miralax

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   12 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria for Stool Recipient :Children and adolescents twelve to twenty one years old, Diagnosis of Crohn's disease made by a primary gastroenterologist based upon history, physical exam, laboratory/radiological studies and gastrointestinal histology; Mild or moderate disease activity based upon PCDAI score (15-45); Parent/guardian and child must be able to comprehend the consent and assent in English; Parent/guardian and participant must be able to attend study visits at baseline, and weeks +2, +6, +12.; Patient must not have medication changes for his/her inflammatory bowel disease medications for at least 1 months prior to enrollment.;Stool donor available from family member; Patient agreeable to nasogastric tube placement

Exclusion Criteria for Stool Recipient: PCDAI <15 or PCDAI >45; Active or history of intraabdominal abscess, perianal abscess, perianal fistula, intraabdominal fistula, stricturing Crohn's disease; Other serious medical conditions such as neurological, liver, kidney, autoimmune or systemic disease; recipients allergic to any product used in the study, including rifaximin, omeprazole and MiraLAX; Pregnant or nursing subjects will be excluded as transplant recipients.;Female recipients of child-bearing potential will abstinent or willing to use adequate birth control from screening until the end of the study. ; Patients who cannot tolerate NG tube placement, such as those with recent surgery or trauma to the nares will be excluded; Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data;

Stool donor inclusion criteria: Family member of child participant with IBD over the age of 18 or Universal Donor known to the PI/co-PI; Willing and able to donate a stool sample

Exclusion criteria for Stool donors: High risk behaviors as outlined in the American Association of Blood Banks Donor History Questionnaire; confirmed lab positivity for: Hepatitis A(IgM),Hepatitis B (serum antigen, core antibody), Hepatitis C (IgG or IgM), HIV 1-2 (PCR), Syphilis (IgG and IgM), EBV(IgM), CMV(IgM) ; Stool sample positive for: c. difficile, salmonella species, shigella species, campylobacter species, Aeromonas hydrophila, yersinia, vibrio parahaemolyticus, vibrio cholerae, e. coli H-0157, H. Pylori, listeria, protozoa, trophozoites and cysts, helminths and ova; Antibiotic use during the 3 months prior to the stool transplant; Diagnosis of IBD, polyposis syndrome, gastrointestinal malignancy in stool donor; Currently on major immunosuppressant medications for example, exogenous glucocorticoids, biological agents, and calcineurin inhibitors; Use of investigational product(s) during the month prior to donation or expected use from screening to donation; Metabolic syndrome or history of bariatric surgery; Diarrheal illness or blood in stool within the month prior to screening; Pregnancy; Malignancy or use of systemic chemotherapy ; Autoimmune disease; Chronic pain syndrome; Atopic disease;Recent ingestion of a potential allergen where recipient has a known allergy to the agent; Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02272868

Contacts
Contact: Jani Klein 206-987-0055 Jani.Klein@seattlechildrens.org

Locations
United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Principal Investigator: David L Suskind, MD         
Sponsors and Collaborators
Seattle Children's Hospital
Investigators
Principal Investigator: David Suskind, MD Seattle Children's Hospital
  More Information

Additional Information:
Responsible Party: David Suskind, Principal Investigator, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT02272868     History of Changes
Other Study ID Numbers: 15262
Study First Received: October 16, 2014
Last Updated: November 16, 2015

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Omeprazole
Rifaximin
Polyethylene glycol 3350
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents
Nucleic Acid Synthesis Inhibitors
Laxatives

ClinicalTrials.gov processed this record on July 21, 2017