Inflammatory Bowel DiseasesNCT04782544
Ganglioside and IBD
A study testing Buttermilk Powder and Anhydrous Milk Fat in people with Inflammatory Bowel Diseases, run by Children's Hospital of Orange County at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 9 to 21 years
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Buttermilk Powder and Anhydrous Milk Fat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jun 2021to 24 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Orange County
Orange, California, 92868
About this study
Official title: Assessing Whether Buttermilk Powder Improves Disease Activity in Pediatric IBD
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.
Read more
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.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Buttermilk Powder, Anhydrous Milk Fat
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buttermilk PowderOther
Treatment with 5.0 g of buttermilk powder daily for 10 weeks.
Anhydrous Milk FatOther
Treatment with 5.0 g of milk powder (90% anhydrous milk fat, 10% buttermilk powder) daily for 10 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Active comparator | 5 grams of buttermilk powder daily for 10 weeks, oral. Receives: Other: Buttermilk Powder |
| Placebo | Placebo comparator | 5 grams of milk powder (10% buttermilk powder, 90% anhydrous milk fat) daily for 10 weeks, oral. Receives: Other: Anhydrous Milk Fat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease activity index
Pediatric 1) Crohn Disease or 2) Ulcerative Colitis disease activity index
Measured: Day 0
Disease activity index
Pediatric 1) Crohn Disease or 2) Ulcerative Colitis disease activity index
Measured: Day 70
Secondary outcomes (10)
ImproveCareNow Physician Global Assessment
A disease activity index
Measured: Day 0
ImproveCareNow Physician Global Assessment
A disease activity index
Measured: Day 70
IMPACT-III questionnaire
quality of life scales (0 = lowest, 100 = highest): well-being, emotional functioning, social functioning, body image
Measured: Day 0
IMPACT-III questionnaire
quality of life scales (0 = lowest, 100 = highest): well-being, emotional functioning, social functioning, body image
Measured: Day 70
Intestinal integrity
Intestinal permeability (lactulose/mannitol) challenge
Measured: Day 0
Intestinal integrity
Intestinal permeability (lactulose/mannitol) challenge
Measured: Day 70
Calprotectin
Stool test
Measured: Day 0
Calprotectin
Stool test
Measured: Day 70
C-reactive protein
Blood test
Measured: Day 0
C-reactive protein
Blood test
Measured: Day 70
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start28 Jun 2021
- Primary completion15 Sep 2023
- Study completion24 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Orange County
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04782544
- Sponsor's protocol ID
- 200109
- Status last verified
- Jul 2022
- First submitted
- 23 Feb 2021
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Whether Buttermilk Powder Improves Disease Activity in Pediatric IBD
- ClinicalTrials.gov ID
- NCT04782544
- Acronym / sponsor ID
- 200109
- Conditions
- Inflammatory Bowel Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Children's Hospital of Orange CountyUniversity, hospital or other
- Study start
- 28 Jun 2021 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 24 Mar 2024 (actual)
- First posted
- 4 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Active comparator | Other: Buttermilk Powder5 grams of buttermilk powder daily for 10 weeks, oral. |
| Placebo | Placebo comparator | Other: Anhydrous Milk Fat5 grams of milk powder (10% buttermilk powder, 90% anhydrous milk fat) daily for 10 weeks, oral. |
Who may qualify
- Ages
- 9 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- Pregnancy
- Previous bowel resection
- Non-ileocolonic location of disease
- Inadequate liver or renal function
- On prescription medication for active infectious disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Buttermilk PowderTreatment with 5.0 g of buttermilk powder daily for 10 weeks. | Other | Treatment |
| Anhydrous Milk FatTreatment with 5.0 g of milk powder (90% anhydrous milk fat, 10% buttermilk powder) daily for 10 weeks. | Other | Placebo |
Primary outcome
Disease activity index
Time frame: Day 0
Pediatric 1) Crohn Disease or 2) Ulcerative Colitis disease activity index
Disease activity index
Time frame: Day 70
Pediatric 1) Crohn Disease or 2) Ulcerative Colitis disease activity index
10 secondary outcomes
ImproveCareNow Physician Global Assessment
Time frame: Day 0
ImproveCareNow Physician Global Assessment
Time frame: Day 70
IMPACT-III questionnaire
Time frame: Day 0
IMPACT-III questionnaire
Time frame: Day 70
Intestinal integrity
Time frame: Day 0
Intestinal integrity
Time frame: Day 70
Calprotectin
Time frame: Day 0
Calprotectin
Time frame: Day 70
C-reactive protein
Time frame: Day 0
C-reactive protein
Time frame: Day 70
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Inflammatory Bowel Diseases
Active, not recruitingObservational study
An Observational Prospective Long-term Exposure Registry of Adult Patients With Moderate-to-Severe Ulcerative Colitis
Ulcerative Colitis
RecruitingPhase 1/2
Safety, Dosage, and Microbiome Engraftment Study of MGT-006 for Ulcerative Colitis (ROOT Study)
Ulcerative Colitis (UC), Ulcerative Colitis, Active Moderate
Recruiting
A Prospective Randomised Study of Treatment Selection Based on Epigenetic Markers Versus Standard of Care Treatment Selection in Adults With CROHN's Disease
Crohn Disease (CD)
Enrolling by invitation
Partial Enteral Nutrition as Therapeutic Augmentation of Advanced Pharmacological Therapy in Patients With Active Crohn's Disease
Crohn's Disease, Active
RecruitingPhase 4
A Remotely Conducted Study to Assess Concentration of TREMFYA in Breast Milk of Lactating Women Who Are Receiving TREMFYA Therapeutically
Psoriasis, Colitis, Ulcerative
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Buttermilk Powder and Anhydrous Milk Fat in people with Inflammatory Bowel Diseases, run by Children's Hospital of Orange County at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease activity index (time frame: Day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.