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Ganglioside

Treatment for Inflammatory Bowel Disease

N/A
Recruiting
Research Sponsored by Children's Hospital of Orange County
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ileal, ileocolonic, colonic location of disease
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 70
Awards & highlights

Study Summary

This trial is testing whether dietary ganglioside is an effective treatment for pediatric patients with inflammatory bowel disease. The primary outcome is the disease activity index, and secondary outcomes include quality of life, intestinal permeability, and C-reactive protein levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
Your disease is located in the small intestine, colon or both.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 70
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 70 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Disease activity index
Secondary outcome measures
C-reactive protein
Calprotectin
IMPACT-III questionnaire
+2 more
Other outcome measures
Albumin, study end
Albumin, study start
Hematocrit, study end
+7 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: TreatmentActive Control1 Intervention
5 grams of buttermilk powder daily for 10 weeks, oral.
Group II: PlaceboPlacebo Group1 Intervention
5 grams of milk powder (10% buttermilk powder, 90% anhydrous milk fat) daily for 10 weeks, oral.

Find a Location

Who is running the clinical trial?

Children's Hospital of Orange CountyLead Sponsor
32 Previous Clinical Trials
4,886 Total Patients Enrolled

Media Library

Buttermilk Powder (Ganglioside) Clinical Trial Eligibility Overview. Trial Name: NCT04782544 — N/A
Inflammatory Bowel Disease Clinical Trial 2023: Buttermilk Powder Highlights & Side Effects. Trial Name: NCT04782544 — N/A
Buttermilk Powder (Ganglioside) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04782544 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are taking part in this clinical research project?

"Affirmative. Clinicaltrials.gov has proof that this clinical trial is actively seeking participants, with 48 openings at one location since it was initially posted on June 28th 2021 and last edited on July 25th 2022."

Answered by AI

Does this clinical trial accommodate individuals aged eighty and over?

"The qualifications for this medical trial mandate that participants are between 9 and 21 years old."

Answered by AI

Who is considered to be the most suitable candidates for this experimental program?

"This clinical trial is looking for 48 subjects, aged between 9 and 21 years old, currently diagnosed with Inflammatory Bowel Disease. Eligible participants must meet the following requirements: age within 9-21 range; mild to moderate IBD according to ImproveCareNow Physician Global Assessment (PGA); or stable severe IBD according to ICN PGA in case it has been present for at least 120 days; ileal, ileocolonic or colonic location of disease."

Answered by AI

Is this clinical trial actively seeking participants?

"Yes, the information on clinicaltrials.gov suggests that this research study is presently open to patients. The trial was first published on June 28th 2021 and has since been revised as of July 25th 2022. Approximately 48 participants are being sought from one site location."

Answered by AI
~13 spots leftby Apr 2025