Status:
TERMINATED
Fecal Microbial Transplant in Pediatric Crohn's Disease
Lead Sponsor:
Seattle Children's Hospital
Conditions:
Crohn's Disease
Eligibility:
All Genders
12-21 years
Phase:
PHASE1
PHASE2
Brief Summary
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.
Detailed Description
Thirty-two patients with mild to moderate active Crohn's Disease (PCDAI 15-45) aged 12-21 will be enrolled in this study. Patients will be randomized into pre-treatment conditioning + FMT versus pre-t...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2016
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT02272868
Start Date
January 1 2015
End Date
October 1 2016
Last Update
September 29 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Seattle Children's Hospital
Seattle, Washington, United States, 98105