Elemental Diet for Inflammatory Bowel Disease

Recruiting in Palo Alto (17 mi)

Overseen byChrista S Zerbe, M.D.

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

No Placebo Group

Prior Safety Data

Trial Summary

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.

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

Able to provide informed consent

I am willing to have genetic tests done on my samples.

I am between 8 and 65 years old.

+4 more

Exclusion Criteria

Pregnancy

Any condition that, in the opinion of the investigator, contraindicates participation in this study will be excluded from study participation.

I am currently on antibiotics for an infection, not just for prevention.

Participant Groups

The study tests if an elemental diet called Neocate Splash can improve gut health by changing stomach bacteria in patients with CGD and IBD. Participants will follow this liquid diet for up to four weeks, starting with a hospital stay, while their symptoms and health markers are monitored.

1Treatment groups

Experimental Treatment

Group I: 1Experimental Treatment1 Intervention

Participants will be on this diet for 4 weeks. The amount per serving will be determined on the basis of the participant s weight and caloric needs, as determined by a staff dietician.