Ganglioside and IBD

Inflammatory Bowel Diseases Clinical Trial

Official title:

Assessing Whether Buttermilk Powder Improves Disease Activity in Pediatric IBD

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04782544
• Other study ID #: 200109
• Status: Recruiting
• Phase: N/A
• Start date: June 28, 2021
• Est. completion date: September 15, 2023

Study information

• Verified date: July 2022
• Source: Children's Hospital of Orange County
• Contact: Megan A Bailey
• Phone: 714-509-8869
• Email: mebailey[@]choc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: September 15, 2023
• Est. primary completion date: June 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Children's Hospital of Orange County	Orange	California

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Orange County

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hemoglobin, study start	g/L, from metabolic panel	Day 0
Other	Hemoglobin, study end	g/L, from metabolic panel	Day 70
Other	Platelets, study start	#, from metabolic panel	Day 0
Other	Platelets, study end	#, from metabolic panel	Day 70
Other	White blood cells, study start	#, from metabolic panel	Day 0
Other	White blood cells, study end	#, from metabolic panel	Day 70
Other	Albumin, study start	g/L, from metabolic panel	Day 0
Other	Albumin, study end	g/L, from metabolic panel	Day 70
Other	Hematocrit, study start	proportion, from metabolic panel	Day 0
Other	Hematocrit, study end	proportion, from metabolic panel	Day 70
Primary	Disease activity index	Pediatric 1) Crohn Disease or 2) Ulcerative Colitis disease activity index	Day 0
Primary	Disease activity index	Pediatric 1) Crohn Disease or 2) Ulcerative Colitis disease activity index	Day 70
Secondary	ImproveCareNow Physician Global Assessment	A disease activity index	Day 0
Secondary	ImproveCareNow Physician Global Assessment	A disease activity index	Day 70
Secondary	IMPACT-III questionnaire	quality of life scales (0 = lowest, 100 = highest): well-being, emotional functioning, social functioning, body image	Day 0
Secondary	IMPACT-III questionnaire	quality of life scales (0 = lowest, 100 = highest): well-being, emotional functioning, social functioning, body image	Day 70
Secondary	Intestinal integrity	Intestinal permeability (lactulose/mannitol) challenge	Day 0
Secondary	Intestinal integrity	Intestinal permeability (lactulose/mannitol) challenge	Day 70
Secondary	Calprotectin	Stool test	Day 0
Secondary	Calprotectin	Stool test	Day 70
Secondary	C-reactive protein	Blood test	Day 0
Secondary	C-reactive protein	Blood test	Day 70