Inflammatory Bowel Diseases
Conditions
Brief 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
OTHERButtermilk Powder
Treatment with 5.0 g of buttermilk powder daily for 10 weeks.
OTHERAnhydrous Milk Fat
Treatment with 5.0 g of milk powder (90% anhydrous milk fat, 10% buttermilk powder) daily for 10 weeks.
Sponsors
Children's Hospital of Orange County
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
9 Years to 21 Years
Healthy volunteers
No
Inclusion criteria
1. Participants age 9-21 years 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
1. Pregnancy 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease activity index | Day 0 | Pediatric 1) Crohn Disease or 2) Ulcerative Colitis disease activity index |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ImproveCareNow Physician Global Assessment | Day 0 | A disease activity index |
| IMPACT-III questionnaire | Day 0 | quality of life scales (0 = lowest, 100 = highest): well-being, emotional functioning, social functioning, body image |
| Intestinal integrity | Day 0 | Intestinal permeability (lactulose/mannitol) challenge |
| Calprotectin | Day 0 | Stool test |
| C-reactive protein | Day 0 | Blood test |
Other
| Measure | Time frame | Description |
|---|---|---|
| Albumin, study start | Day 0 | g/L, from metabolic panel |
| Albumin, study end | Day 70 | g/L, from metabolic panel |
| Hemoglobin, study start | Day 0 | g/L, from metabolic panel |
| Hematocrit, study end | Day 70 | proportion, from metabolic panel |
| Hematocrit, study start | Day 0 | proportion, from metabolic panel |
| Hemoglobin, study end | Day 70 | g/L, from metabolic panel |
| Platelets, study start | Day 0 | #, from metabolic panel |
| Platelets, study end | Day 70 | #, from metabolic panel |
| White blood cells, study start | Day 0 | #, from metabolic panel |
| White blood cells, study end | Day 70 | #, from metabolic panel |
Countries
United States
Outcome results
None listed