Neocate Splash for Intestinal Diseases

Phase-Based Progress Estimates

Effectiveness

Safety

Intestinal Diseases+5 More

Neocate Splash - Other

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Eligibility

Any Age

All Sexes

What conditions do you have?

Select

Eligibility

Any Age

All Sexes

What conditions do you have?

Select

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.

Eligible Conditions

Intestinal Diseases
Chronic Granulomatous Disease (CGD)
Inflammatory Bowel Diseases (IBD)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Intestinal Diseases

Single arm study

Plant-based fasting-mimicking diet

Allogeneic peripheral blood stem cell

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: Day 28 and 56

Day 0 to 27

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

Day 0 to 56

Initiation of antibiotics.

Unexpected AEs possibly, probably, or definitely related to the elemental diet.

Weight loss.

Day 28 and 56

Changes in the HBI at completion of the elemental diet and at 4 weeks after completion.

Day 56

Change in alpha and beta diversity after diet

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

Changes in fecal calprotectin, ESR, and CRP.

Trial Safety

Safety Progress

2 of 3

This is further along than 68% of similar trials

Other trials for Intestinal Diseases

Single arm study

Plant-based fasting-mimicking diet

Allogeneic peripheral blood stem cell

Trial Design

1 Treatment Group

1 1 of 1

Experimental Treatment

10 Total Participants · 1 Treatment Group

Primary Treatment: Neocate Splash · No Placebo Group · Phase 2

Other

Experimental Group · 1 Intervention: Neocate Splash · Intervention Types: Other

Trial Logistics

Trial Timeline

Approximate Timeline

Screening: ~3 weeks

Treatment: Varies

Reporting: day 28 and 56

Who is running the clinical trial?

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

3,127 Previous Clinical Trials

5,060,961 Total Patients Enrolled

10 Trials studying Intestinal Diseases

2,704 Patients Enrolled for Intestinal Diseases

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

7 Previous Clinical Trials

941 Total Patients Enrolled

1 Trials studying Intestinal Diseases

339 Patients Enrolled for Intestinal Diseases

Eligibility Criteria

Age Any Age · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:

You have a SES-CD > 3 and/or HBI ≥ 5.

You have confirmed diagnoses of celiac disease, celiac disease-associated colitis, and inflammatory bowel disease.

You are willing to allow your blood to be stored for future research.

You are willing to be admitted as an inpatient for up to 2 weeks to initiate the elemental diet.

About The Reviewer

Michael Gill - B. Sc.

First Published: October 29th, 2021

Last Reviewed: October 15th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References