Neocate Splash for Intestinal Diseases

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Intestinal Diseases+5 More
Neocate Splash - Other
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

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

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

1
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 preview

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.