ImmuneSense™ IBD Study

ImmuneSense™ IBD Study

This study will enroll adult and pediatric participants across 3 phases: Research phase, Clinical Validation (CV) and Analytical Validation (AV) phase.

Sites selected to participate in the study will enroll participants in the either the Research phase or CV and AV phase. Research Phase will enroll participants in Cohort 1 Pre-diagnosis/+GI symptoms only.

CV and AV phase will be open to enrollment in parallel. CV phase will enroll participants in Cohort 2 Diagnosed IBD, Pre-treatment, Cohort 3 Potential Cross-Reactive Diseases and Cohort 4 Healthy controls.

AV phase will enroll participants in Cohort 2 Diagnosed IBD, Pre-treatment and Cohort 4 Healthy controls. Enrollment will be ongoing until sponsor notification for closure.

Cohort 1: Pre-diagnosis/+GI symptoms Inclusion criteria

• i.GI symptoms with clinical suspicion for inflammation and planned for endoscopy at discretion of clinician
• ii. Male and female participants of any race and ethnicity between 7 to 89 years of age (inclusive) at the time of enrolling in the study
• iii. Must be able to communicate with the investigator, understand and comply with the requirements of the study

Exclusion Criteria

• Age <7 years or >89 years
• Known IBD (Ulcerative colitis, Crohn's disease, indeterminate colitis) and Celiac
• Known active malignancy
• Active Hepatitis B, C or HIV infection(s)
• Use of systemic high dose corticosteroids (above 20mg/day prednisone by mouth) within 30 days prior to the blood draw
• Protected populations including pregnant women, prisoners, mentally disabled persons, and wards-of-the state
• Any significant condition, laboratory abnormality, or psychiatric illness that would prevent the participant from safely participating in the study
• Donated more than 500cc or 1 pint of blood in the past 60 days prior to the blood draw (at the discretion of the investigator)

Cohort 2: Diagnosed IBD, Pre-treatment Inclusion criteria

• Diagnosis of Crohn's disease or Ulcerative colitis made with endoscopy (within 6 months), clinical, imaging, and histological findings.
• Male and female participants of any race and ethnicity between 7 to 89 years of age (inclusive) at the time of enrolling in the study
• Must be able to communicate with the investigator, understand and comply with the requirements of the study

Exclusion Criteria

• Age <7 years or >89 years
• Known active malignancy
• Known Celiac disease
• Active Hepatitis B, C or HIV infection(s)
• Active gastrointestinal infection within 30 days prior to enrollment
• Protected populations including pregnant women, prisoners, mentally disabled persons, and wards-of-the state
• Any significant condition, laboratory abnormality, or psychiatric illness that would prevent the participant from safely participating in the study
• Donated more than 500cc or 1 pint of blood in the past 60 days prior to the blood draw (at the discretion of the investigator)
• On any treatment for IBD- systemic corticosteroids within 30 days, immunomodulator, 5-ASA, biologic therapy
• Plan to initiate therapy as part of a clinical trial of a non-FDA-approved IBD therapy

Cohort 3: Potential Cross-Reactive Disease States Inclusion criteria

• Confirmed, documented diagnoses for one of the following diseases:
• Irritable Bowel Syndrome, Functional Diarrhea (Endoscopy negative for inflammation)
• Celiac disease (Serology positive (ttg IgA+) AND Upper endoscopy confirming Celiac disease diagnosis)
• Diverticulitis, and other forms of microscopic colitis
• Infectious etiologies: E. coli, Klebsiella pneumoniae, Salmonella spp., Shigella spp., Yersinia spp (Positive stool culture or PCR)
• For infections, active infections are required or within 30 days of infection.
• Male and female participants of any race and ethnicity between 7 to 89 years of age (inclusive) at the time of enrolling in the study
• Must be able to communicate with the investigator, understand and comply with the requirements of the study

Exclusion Criteria

• Age <7 years or >89
• Individuals with a prior or current clinical diagnosis of IBD
• Active Hepatitis B, C or HIV infection(s)
• Protected populations including pregnant women, prisoners, mentally disabled persons, and wards-of-the state
• Any significant condition, laboratory abnormality, or psychiatric illness that would prevent the participant from safely participating in the study
• Donated more than 500cc or 1 pint of blood in the past 60 days prior to the blood draw (at the discretion of the investigator)

Cohort 4: Healthy Controls Inclusion criteria

• Male and female participants of any race and ethnicity between 7 to 89 years of age (inclusive) at the time of enrolling in the study
• Must be able to communicate with the investigator, understand and comply with the requirements of the study Exclusion criteria
• Age <7 years or >89
• GI symptoms in last 90 days (Abdominal pain, diarrhea, blood in stool, weight loss, vomiting)
• Individuals with a prior or current clinical diagnosis of IBD, Celiac disease, active infection
• Family history of Crohn's disease, indeterminate colitis or ulcerative colitis
• Active Hepatitis B, C or HIV infection(s)
• Protected populations including pregnant women, prisoners, mentally disabled persons, and wards-of-the state
• Any significant condition, laboratory abnormality, or psychiatric illness that would prevent the participant from safely participating in the study
• Donated more than 500cc or 1 pint of blood in the past 60 days prior to the blood draw (at the discretion of the investigator)