Ganglioside and IBD
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Treatment 5 grams of buttermilk powder daily for 10 weeks, oral. |
Other: Buttermilk Powder
Treatment with 5.0 g of buttermilk powder daily for 10 weeks.
|
| Placebo Comparator: Placebo 5 grams of milk powder (10% buttermilk powder, 90% anhydrous milk fat) daily for 10 weeks, oral. |
Other: Anhydrous Milk Fat
Treatment with 5.0 g of milk powder (90% anhydrous milk fat, 10% buttermilk powder) daily for 10 weeks.
|
Outcome Measures
Primary Outcome Measures
- Disease activity index [Day 0]
Pediatric 1) Crohn Disease or 2) Ulcerative Colitis disease activity index
- Disease activity index [Day 70]
Pediatric 1) Crohn Disease or 2) Ulcerative Colitis disease activity index
Secondary Outcome Measures
- ImproveCareNow Physician Global Assessment [Day 0]
A disease activity index
- ImproveCareNow Physician Global Assessment [Day 70]
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
- IMPACT-III questionnaire [Day 70]
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
- Intestinal integrity [Day 70]
Intestinal permeability (lactulose/mannitol) challenge
- Calprotectin [Day 0]
Stool test
- Calprotectin [Day 70]
Stool test
- C-reactive protein [Day 0]
Blood test
- C-reactive protein [Day 70]
Blood test
Other Outcome Measures
- Hemoglobin, study start [Day 0]
g/L, 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
- Albumin, study start [Day 0]
g/L, from metabolic panel
- Albumin, study end [Day 70]
g/L, from metabolic panel
- Hematocrit, study start [Day 0]
proportion, from metabolic panel
- Hematocrit, study end [Day 70]
proportion, from metabolic panel
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Participants age 9-21 years
-
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
-
Ileal, ileocolonic, colonic location of disease
Exclusion Criteria:
-
Pregnancy
-
Previous bowel resection
-
Non-ileocolonic location of disease
-
Inadequate liver or renal function
-
On prescription medication for active infectious disease
-
Drug/alcohol abuse
-
Other serious medical conditions
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Children's Hospital of Orange County | Orange | California | United States | 92868 |
Sponsors and Collaborators
- Children's Hospital of Orange County
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 200109