This study is currently recruiting participants.
Number
19-I-0108
Sponsoring Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Recruitment Detail
Type: Enrolling by Invitation Gender: Male & Female Min Age: 8 Years Max Age: 65 Years
Referral Letter Required
Yes
Population Exclusion(s)
Pregnant Women
Keywords
Inflammatory Bowel Disease; Crohn disease; Ulcerative Colitis; Glucocorticoids; Microbiome
Recruitment Keyword(s)
None
Condition(s)
Chronic Granulomatous Disease; Inflammatory Bowel Disease
Investigational Drug(s)
Investigational Device(s)
Intervention(s)
Other: Neocate Splash
Supporting Site
National Institute of Allergy and Infectious Diseases
Bacteria that live inside the stomach and intestines are important for health. Chronic granulomatous disease (CGD) and inflammatory bowel disease (IBD) can make people have unhealthy bacteria. This can lead to gastrointestinal (GI) problems. Researchers want to see if people with CGD and IBD feel better when they change the bacteria in the stomach by following a special liquid diet.
Objective:
To see if an elemental diet can change the bacteria in the stomach and intestines of people with CGD and IBD. Also, to see if this helps GI symptoms.
Eligibility:
People ages 8-65 years with CGD, CGD-associated colitis, and IBD.
Design:
Participants will first be screened with:
Upper GI endoscopy and/or colonoscopy. A long, thin tube with a tiny camera at the end will be passed into the participant s body through the mouth or anus. Tissue will be collected. Participants will be sedated for the procedure. They will be sedated using a special mask or small plastic tube placed in an arm vein using a needle.
Participants will be put on the special diet for up to 4 weeks. They will stay in the hospital for the first 1-2 weeks. They will have check-ups. They will have blood, urine, and stool samples collected. They will keep a symptom diary to record how they feel and any GI symptoms.
Participants will have 2 follow-up visits. The first will be right after they finish the diet. The second will be 4 weeks later. They will have blood, urine, and stool samples collected. They will learn about re-introducing other foods into their diet.
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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.
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.
Principal Investigator
Referral Contact
For more information: