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 @ 3:50 PM
Ignite Modification Date:
2025-12-24 @ 3:50 PM
NCT ID:
NCT02134392
Eligibility Criteria:
Inclusion Criteria:
Recipient inclusion criteria:
* Documented laboratory-confirmed clostridium difficile infection
* Documentation of ongoing diarrhea at time of recruitment
* Children ≥2 years old, \<18 years old; young adults \>18 years old, \<21 years old
* Undergoing clinically-indicated colonoscopy
* Recurrent c-diff infection (three or more occurrences)
Donor inclusion criteria:
* First-degree relative recommended, but not compulsory
* ≥ 18 years old
* In good health
* No antibiotic use within the last 90 days
* In "low risk" category on modified DHQ (See above)
Exclusion Criteria:
* Recipient exclusion criteria
* Severe comorbid condition (at discretion of the principal investigator)
* On immunosuppressive medications (high dose steroids 30 mg/kg of methylprednisolone)
* Severe or fulminant C. difficile colitis
* Toxic appearance
* Signs of hemodynamic instability
* Peritoneal signs on physical exam
* Anemia on complete blood count
* electrolyte imbalances on basic metabolic panel
* Considerations for Increased Risk of Adverse Events Should Be Given to patients with decompensated liver cirrhosis, advanced HIV/acquired immune deficiency syndrome, recent bone marrow transplant, or other cause of severe immunodeficiency.
* History of severe anaphylactic shock
Donor exclusion criteria:
* Abnormal stools
* Abdominal complaints
* History of inflammatory bowel disease or gastrointestinal malignancy
* Symptoms indicative of irritable bowel syndrome or other chronic pain syndromes (e.g. chronic fatigue syndrome, fibromyalgia)
* History of systemic autoimmunity (e.g. multiple sclerosis, connective tissue disease)
* Recent use of potent immunosuppressive medications (calcineurin inhibitors, exogenous glucocorticoids, biological agents, etc..)
* Recent ingestion of a potential allergen (e.g. nuts) where recipient has a known allergy to this (these) agent(s)
* Known communicable disease
* Neurologic, neurodevelopmental or neurodegenerative disorders
* History of malignancy
* Has consumed any foods/medications to which the recipient is allergic within the designated period of time
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
21 Years
Study:
NCT02134392
Study Brief:
Protocol Section:
NCT02134392