Elemental Diet for Treatment of Inflammatory Bowel Disease in Patients With Chronic Granulomatous Disease

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Jun 11, 2019

Keywords

ClinConnect Summary

Chronic granulomatous disease (CGD) is a rare genetic immune disorder that results in recurrent and severe infections, and inflammatory dysregulation. For almost 50% of patients with CGD, this inflammation causes severe inflammatory bowel disease (IBD). However, treatment is long term and challenging as CGD-IBD is prone to relapse, and use of immune modulators must be balanced with increased risk of infectious complications. Conventional IBD (Crohn disease and ulcerative colitis) is likely caused by an inappropriate inflammatory response to intestinal microbes, which is influenced by the en...

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Eligibility criteria

• * INCLUSION CRITERIA:
• Individuals must meet all of the following criteria to be eligible for study participation:
• • Aged 8-65 years.
• • Have confirmed diagnoses of CGD, CGD-associated colitis, and IBD.
• • Have a Simple Endoscopic Score for Crohn Disease (SES-CD) \> 3 and/or HBI \>= 5.
• • Able to provide informed consent.
• • Willing to allow storage of biological samples for future research.
• • Willing to allow genetic testing on biological samples.
• • Willing to be admitted as inpatient for up to 2 weeks to initiate the elemental diet.
• EXCLUSION CRITERIA:
• • Pregnancy.
• • Active or ongoing infection that requires antibiotics other than the participant s known prophylaxis medications.
• • Any condition that, in the opinion of the investigator, contraindicates participation in this study will be excluded from study participation.