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Molecular Study of Idiopathic Inflammatory Bowel Diseases: Crohn's, Colitis and Other Gut Conditions

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Colitis+5

+ Colonic Diseases

+ Digestive System Diseases

+19 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: August 1998
See protocol details

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Study ContactSandra M Maxwell, R.N.More contacts
Last updated: July 8, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 7, 1998

Actual date on which the first participant was enrolled.

STUDY DESCRIPTION: This natural history protocol provides for the evaluation of patients with idiopathic inflammatory bowel diseases (ulcerative colitis, Crohn s disease, IBD associated with immunodeficiency and genetic diseases such as chronic granulomatous disease, and additional undefined inflammatory conditions of the gut) either on an inpatient or outpatient basis. OBJECTIVES: Primary Objective: To identify the molecular abnormalities that result in inflammatory bowel diseases and develop novel therapies based on these discoveries. Secondary Objectives: To enroll patients with IBD in order to obtain clinical, therapeutic, immunological, and genetic data relevant to the research study of their disease. ENDPOINTS: Primary Endpoint: Comparison of the molecular and cellular abnormalities that result in inflammatory bowel diseases

NCT00001184
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Study ContactSandra M Maxwell, R.N.More contacts
Last updated: July 8, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

1000 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ColitisColonic DiseasesDigestive System DiseasesGastroenteritisGastrointestinal DiseasesIntestinal DiseasesColitis, UlcerativeInflammatory Bowel Diseases

Criteria

14 inclusion criteria required to participate
Must be willing to submit samples for storage.
Must be >=18 years old.
Must be willing to undergo blood draw and/or upper endoscopy and colonoscopy with biopsy to obtain material for research purposes.
The employee subject s privacy and confidentiality will be preserved in accordance with NIH Clinical Center and NIAID policies, which define the scope and limitations of the protections.
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5 exclusion criteria prevent from participating
Acute systemic or intestinal infection requiring antibiotics
Any condition that, in the investigator s opinion, places the patient at undue risk by participating in the study.
History of inflammatory bowel disease.
Failure to meet the inclusion criteria.
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

National Institutes of Health Clinical Center

Bethesda, United StatesOpen National Institutes of Health Clinical Center in Google Maps
Recruiting
One Study Center