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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 is a NA study that has completed, run by Children's Hospital of Orange County. The registered enrollment target is 11 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04782544
The ClinicalTrials.gov registry entry for NCT04782544 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Hospital of Orange County, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Buttermilk Powder is the first listed.
NCT04782544 reports 0 study locations.
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.
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