NCT04782544

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 4, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

June 28, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 24, 2024

Completed
Last Updated

March 13, 2025

Status Verified

July 1, 2022

Enrollment Period

2.2 years

First QC Date

February 23, 2021

Last Update Submit

March 11, 2025

Conditions

Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (2)

  • Disease activity index

    Pediatric 1) Crohn Disease or 2) Ulcerative Colitis disease activity index

    Day 0

  • Disease activity index

    Pediatric 1) Crohn Disease or 2) Ulcerative Colitis disease activity index

    Day 70

Secondary Outcomes (10)

  • ImproveCareNow Physician Global Assessment

    Day 0

  • ImproveCareNow Physician Global Assessment

    Day 70

  • IMPACT-III questionnaire

    Day 0

  • IMPACT-III questionnaire

    Day 70

  • Intestinal integrity

    Day 0

  • +5 more secondary outcomes

Other Outcomes (10)

  • Hemoglobin, study start

    Day 0

  • Hemoglobin, study end

    Day 70

  • Platelets, study start

    Day 0

  • +7 more other outcomes

Study Arms (2)

Treatment

ACTIVE COMPARATOR

5 grams of buttermilk powder daily for 10 weeks, oral.

Other: Buttermilk Powder

Placebo

PLACEBO COMPARATOR

5 grams of milk powder (10% buttermilk powder, 90% anhydrous milk fat) daily for 10 weeks, oral.

Other: Anhydrous Milk Fat

Interventions

Buttermilk PowderOTHER

Treatment with 5.0 g of buttermilk powder daily for 10 weeks.

Treatment
Anhydrous Milk FatOTHER

Treatment with 5.0 g of milk powder (90% anhydrous milk fat, 10% buttermilk powder) daily for 10 weeks.

Placebo

Eligibility Criteria

Age9 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Orange County

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2021

First Posted

March 4, 2021

Study Start

June 28, 2021

Primary Completion

September 15, 2023

Study Completion

March 24, 2024

Last Updated

March 13, 2025

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)