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Elemental Diet for Inflammatory Bowel Disease

Phase 2

Waitlist Available

Led By Christa S Zerbe, M.D.

Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged 8-65 years

Have a Simple Endoscopic Score for Crohn Disease (SES-CD) > 3 and/or HBI >= 5

Must not have

Active or ongoing infection that requires antibiotics other than the participant's known prophylaxis medications

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 56

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a special diet can help improve GI symptoms in people with CGD and IBD by changing the bacteria in their stomach and intestines.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly listed, potential side effects may include discomfort from dietary changes such as nausea or digestive issues. The procedures like endoscopy might cause soreness or risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 8 and 65 years old.

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My Crohn's disease is active, as shown by my test scores.

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I have been diagnosed with CGD, CGD-related colitis, or IBD.

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I am willing to stay in the hospital for 2 weeks for a special diet.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 56

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 56

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 56 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in the relative abundance of proteobacteria in stool samples obtained after elemental diet.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 5Eligibility criteria met