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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 28 and 56

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 28 and 56

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 28 and 56

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 28 and 56 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Ability to tolerate 4 weeks of elemental diet as measured by > 75% of caloric intake via elemental diet over the 4-week period.

Change in alpha and beta diversity after diet

Changes in fecal calprotectin, ESR, and CRP.

+4 more

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 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

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

3,268 Previous Clinical Trials

5,481,122 Total Patients Enrolled

Christa S Zerbe, M.D.Principal InvestigatorNational Institute of Allergy and Infectious Diseases (NIAID)

7 Previous Clinical Trials

602 Total Patients Enrolled

Media Library

Neocate Splash (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03983837 — Phase 2

Chronic Granulomatous Disease Research Study Groups: 1

Chronic Granulomatous Disease Clinical Trial 2023: Neocate Splash Highlights & Side Effects. Trial Name: NCT03983837 — Phase 2

Neocate Splash (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03983837 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is participation in this trial permissible for elderly individuals?

"This clinical trial has an age parameter of 8 to 65, thus all patient aged between these two boundaries are eligible."

Answered by AI

Are there any vacancies permitting participants to join this trial?

"Clinicaltrials.gov reports that, since the trial's initial posting on June 23rd 2021 and its last update on July 6th 2022, this particular medical research is no longer enrolling patients. Conversely, there are currently 229 other clinical trials actively recruiting participants."

Answered by AI

Am I a viable candidate for this medical investigation?

"This clinical trail is searching for 10 participants who have intestinal diseases and fit within the age range of 8-65. To qualify, one must meet both criteria."

Answered by AI