An interventional study of Buttermilk Powder and Anhydrous Milk Fat in Inflammatory Bowel Diseases, sponsored by Children's Hospital of Orange County. Completed at 1 site in United States. Open to participants aged 9 Years to 21 Years. Per ClinicalTrials.gov, last updated 2025-03-13.
Sponsored by Children's Hospital of Orange County · Not applicable, Interventional, and Treatment
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.
1,460 studies on the registry are indexed under Inflammatory Bowel Diseases; 436 are open to participants now.
This study's enrollment of 11 is below the median of 70 across 770 interventional studies indexed under Inflammatory Bowel Diseases.
Browse Inflammatory Bowel Diseases studies →Children's Hospital of Orange County is the lead sponsor of 17 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
5 grams of buttermilk powder daily for 10 weeks, oral.
Other: Buttermilk Powder
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 buttermilk powder daily for 10 weeks.
Treatment with 5.0 g of milk powder (90% anhydrous milk fat, 10% buttermilk powder) daily for 10 weeks.
Disease activity index
Pediatric 1) Crohn Disease or 2) Ulcerative Colitis disease activity index
Time frame: Day 0
Disease activity index
Pediatric 1) Crohn Disease or 2) Ulcerative Colitis disease activity index
Time frame: Day 70
ImproveCareNow Physician Global Assessment
A disease activity index
Time frame: Day 0
ImproveCareNow Physician Global Assessment
A disease activity index
Time frame: Day 70
IMPACT-III questionnaire
quality of life scales (0 = lowest, 100 = highest): well-being, emotional functioning, social functioning, body image
Time frame: Day 0
IMPACT-III questionnaire
quality of life scales (0 = lowest, 100 = highest): well-being, emotional functioning, social functioning, body image
Time frame: Day 70
Intestinal integrity
Intestinal permeability (lactulose/mannitol) challenge
Time frame: Day 0
Intestinal integrity
Intestinal permeability (lactulose/mannitol) challenge
Time frame: Day 70
Calprotectin
Stool test
Time frame: Day 0
Calprotectin
Stool test
Time frame: Day 70
C-reactive protein
Blood test
Time frame: Day 0
C-reactive protein
Blood test
Time frame: Day 70
Hemoglobin, study start
g/L, from metabolic panel
Time frame: Day 0
Hemoglobin, study end
g/L, from metabolic panel
Time frame: Day 70
Platelets, study start
#, from metabolic panel
Time frame: Day 0
Platelets, study end
#, from metabolic panel
Time frame: Day 70
White blood cells, study start
#, from metabolic panel
Time frame: Day 0
White blood cells, study end
#, from metabolic panel
Time frame: Day 70
Albumin, study start
g/L, from metabolic panel
Time frame: Day 0
Albumin, study end
g/L, from metabolic panel
Time frame: Day 70
Hematocrit, study start
proportion, from metabolic panel
Time frame: Day 0
Hematocrit, study end
proportion, from metabolic panel
Time frame: Day 70
Plan to share: No
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This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Children's Hospital of Orange County