Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2025-12-24 @ 5:37 PM
NCT ID:
NCT02272868
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
21 Years
Study:
NCT02272868
Study Brief:
Protocol Section:
NCT02272868