NCT03983837CompletedPhase 2
Elemental Diet for Treatment of Inflammatory Bowel Disease in Patients With Chronic Granulomatous Disease
Source: ClinicalTrials.gov · Last updated 11 Dec 2025
Brief summary (registry, in English)
Background: 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 up to 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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 3 (actual)
- First submitted
- 7 Jun 2019
- Start date
- 23 Jun 2021
- Primary completion date
- 18 Nov 2025
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Diseases
- Crohn's disease, Ulcerative colitis
- NCT number
- NCT03983837
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 3
- From 23 Jun 2021 to the primary completion date, 18 Nov 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- Pregnancy.
Criteria the registry did not label
- 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.
Age in the registry: 8 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Institutes of Health Clinical Center Coordinator of this site? Confirm its status | Bethesda | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.