Elemental Diet for Inflammatory Bowel Disease
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, it mentions that active infections requiring antibiotics, other than known preventive medications, are excluded, which might imply some restrictions. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the treatment Neocate Splash for inflammatory bowel disease?
Is the elemental diet safe for humans?
How is the treatment Neocate Splash unique for inflammatory bowel disease?
Neocate Splash, an elemental diet, is unique because it provides nutrition in a form that is easily absorbed by the body, reducing inflammation and improving intestinal integrity without the need for starter regimens. It is administered through a nasogastric tube, allowing for constant infusion, which can lead to increased nutrient intake and improved nitrogen balance, making it different from traditional drug therapies.123910
What is the purpose of this trial?
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.
Research Team
Christa S Zerbe, M.D.
Principal Investigator
National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria
This trial is for people aged 8-65 with Chronic Granulomatous Disease (CGD) and Inflammatory Bowel Disease (IBD). They should have certain levels of disease activity, be willing to stay in the hospital for up to two weeks, and consent to genetic testing. Pregnant individuals or those with conditions that make participation unsafe are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are put on a special elemental diet for up to 4 weeks, with inpatient stay for up to 2 weeks
Follow-up
Participants have 2 follow-up visits to monitor changes in microbiome and reintroduce normal food
Treatment Details
Interventions
- Neocate Splash
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor