Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
11 participants
INTERVENTIONAL
2021-06-28
2024-03-24
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Treatment
5 grams of buttermilk powder daily for 10 weeks, oral.
Buttermilk Powder
Treatment with 5.0 g of buttermilk powder daily for 10 weeks.
Placebo
5 grams of milk powder (10% buttermilk powder, 90% anhydrous milk fat) daily for 10 weeks, oral.
Anhydrous Milk Fat
Treatment with 5.0 g of milk powder (90% anhydrous milk fat, 10% buttermilk powder) daily for 10 weeks.
Interventions
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Buttermilk Powder
Treatment with 5.0 g of buttermilk powder daily for 10 weeks.
Anhydrous Milk Fat
Treatment with 5.0 g of milk powder (90% anhydrous milk fat, 10% buttermilk powder) daily for 10 weeks.
Eligibility Criteria
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Inclusion Criteria
2. Mild-moderate IBD defined by ImproveCareNow (ICN) Physician Global Assessment (PGA); OR severe IBD defined by ICN PGA if stable for at least 120 days
3. Ileal, ileocolonic, colonic location of disease
Exclusion Criteria
2. Previous bowel resection
3. Non-ileocolonic location of disease
4. Inadequate liver or renal function
5. On prescription medication for active infectious disease
6. Drug/alcohol abuse
7. Other serious medical conditions
9 Years
21 Years
ALL
No
Sponsors
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Children's Hospital of Orange County
OTHER
Responsible Party
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Locations
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Children's Hospital of Orange County
Orange, California, United States
Countries
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Other Identifiers
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200109
Identifier Type: -
Identifier Source: org_study_id
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