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NCT04782544 · ClinicalTrials.gov registry record · NA
Ganglioside and IBD
A NA study, sponsored by Children's Hospital of Orange County.
- Completed
- Registry status
- NA
- Development phase
- 11
- Enrollment target
NCT04782544: Completed NA study, sponsored by Children's Hospital of Orange County.
NCT04782544 is a NA study that has completed, run by Children's Hospital of Orange County. The registered enrollment target is 11 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04782544, a NA study, has completed, sponsored by Children's Hospital of Orange County.
- COMPLETED
- Registry status
- NA
- Development phase
- 11 participants
- Enrollment target
Study Summary
Context. Inflammatory bowel disease (IBD) is a chronic and debilitating disorder. Novel treatment strategies aimed to resolve intestinal inflammation and induce disease remission are necessary. Dietary gangliosides are safe for consumption, bioavailable, and have shown clinical benefit in patients with inflammatory intestinal disease. Objectives. The primary objective is this study is to determine the efficacy of dietary ganglioside in improving disease activity indices in pediatric patients with IBD. Secondary objectives include demonstrating the effectiveness of dietary ganglioside for improving quality of life, improving intestinal integrity, and reducing inflammation. Study Design. Intervention: controlled trial (pilot). Participants. Inclusion criteria: aged 9-21 years, diagnosis of ulcerative colitis (UC) or ileal or colonic Crohn Disease (CD), active disease. Exclusion criteria: pregnancy, inadequate liver or renal function, active infectious disease, previous bowel resection, disease remission, drug/alcohol abuse, other serious medical conditions, indeterminate colitis. Study Intervention. Patients with IBD (n=48) will be allocated to consume ganglioside treatment or placebo daily for 10 weeks. Treatment group will consume five grams of buttermilk powder daily or anhydrous milk fat. Outcome Measures. The primary outcome is the disease activity index: pediatric Crohn's Disease Activity Index (pCDAI) or pediatric Ulcerative Colitis Activity Index (pUCAI). Secondary outcomes include: quality of life (IMPACT-III questionnaire), intestinal permeability (lactulose/mannitol urinary assay), C-reactive protein (CRP; blood exam), calprotectin (fecal exam). Expected Outcomes. Relative to the placebo group, the treatment group will have improved disease activity indices, quality of life, and intestinal integrity over the 10-week study period. The treatment group will also show reduction in inflammation and calprotectin relative to the placebo group.
Primary Outcome
Pediatric 1) Crohn Disease or 2) Ulcerative Colitis disease activity index
Interventions
- OTHER Buttermilk Powder
- OTHER Anhydrous Milk Fat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2021-06-28 |
| Est. Completion | 2024-03-24 |
| Phase | NA |
What the finished NCT04782544 record still lists
NCT04782544 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Buttermilk Powder is the first listed.
NCT04782544 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04782544 about?
NCT04782544 is a clinical study titled "Ganglioside and IBD". Context. Inflammatory bowel disease (IBD) is a chronic and debilitating disorder. Novel treatment strategies aimed to resolve intestinal inflammation and induce disease remission are necessary. Dietary gangliosides are safe for consumption, bioavailable, and have shown clinical benefit in patients w...
What is the current status of trial NCT04782544?
This trial is currently completed. It is a NA study. The enrollment target is 11 participants. The study started on 2021-06-28. Estimated completion is 2024-03-24.
What interventions are being tested in trial NCT04782544?
The interventions under investigation include: Buttermilk Powder (OTHER), Anhydrous Milk Fat (OTHER).
Who is sponsoring clinical trial NCT04782544?
This trial is sponsored by Children's Hospital of Orange County, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04782544's enrollment target sits among peer trials
11 1927th of 2000 higher than 74 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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