Ulcerative Colitis
Butyrate Enemas for Children and Young Adults With Ulcerative Colitis
This study is investigating whether 12 weeks of daily butyrate enemas affect disease activity and inflammatory markers in people ages 7 to 21 with mild to moderate ulcerative colitis.
Registry title: The Use of Butyrate Therapy in Pediatric Ulcerative Colitis
1 recruiting U.S. site ↓Study at a glance
- Age
- 7 Years–21 Years
- Treatment
- Butyrate
- Design
- Not provided
- Central study contact
- Sonia Michail, MD3233611353sonia.michail@hotmail.com
- Sponsor
- Children's Hospital Los Angeles
Research question
In young people with mild to moderate ulcerative colitis, what changes in clinical disease activity and inflammatory markers occur after 12 weeks of daily butyrate enemas?
Participant snapshot
Who the study is looking for
- The study is looking for people ages 7 to 21.
- The study is looking for people with mild to moderate ulcerative colitis.
- People of any sex may be considered; healthy volunteers are not accepted.
- The listed recruiting location is Children's Hospital Los Angeles in Los Angeles, California.
Participation overview
What participation may involve
Participants receive a butyrate enema once each day while standard ulcerative colitis management, routine laboratory studies, and endoscopy are performed. What participation may involve: - Use a butyrate enema once daily. - Continue with standard disease management as directed during the study. - Undergo routine laboratory studies and endoscopy. - Have ulcerative colitis activity assessed using the Pediatric Ulcerative Colitis Activity Index. - Have inflammatory markers assessed using erythrocyte sedimentation rate, C-reactive protein, and calprotectin. The reported intervention period is 12 weeks.
Study interventions
What participants may receive or do
- Butyrate: Participants receive a butyrate enema once daily for 12 weeks.
Study design
How the comparison works
This Phase 2 interventional study plans to enroll 10 participants in one experimental group, with everyone receiving daily butyrate enemas for 12 weeks. The registry reports allocation as not applicable and uses a single-group design, so participants are not assigned among multiple study groups. The study is open label with no masking, meaning the assigned intervention is not concealed. The registry describes only one experimental arm and does not report a separate comparison group.
Reported activities
Procedures and tests
- Daily administration of a butyrate enema for 12 weeks.
- Routine laboratory studies are performed during the 12-week intervention period.
- Endoscopy is included as part of standard disease management during the study.
- Clinical disease activity is measured with the Pediatric Ulcerative Colitis Activity Index.
- Inflammatory-marker testing includes erythrocyte sedimentation rate, C-reactive protein, and calprotectin.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- Participants must be 7 to 21 years old.
- Participants must have mild to moderate ulcerative colitis.
Possible reasons someone may not be able to join
- The registry excludes people with ulcerative colitis therapy within four weeks before study medication begins, but it does not specify which therapies count.
- People with infectious colitis are excluded.
- Pregnant people are excluded.
Important unknowns
What the record does not make clear
- The registry does not state how many in-person visits are required or when they occur.
- The detailed description says standard disease management will continue, while the eligibility criteria exclude ulcerative colitis therapy within four weeks of starting study medication; the permitted treatments are not identified.
- A four-week treatment-related exclusion is listed, but the therapies covered and whether stopping treatment is required are not explained.
- Endoscopy is mentioned, but its timing, number, purpose, and whether it is required specifically for research are not stated.
- The registry does not describe what treatment is available if ulcerative colitis worsens during the study.
- The registry does not explain which study-related or routine-care costs are covered or billed to insurance.
- The registry does not report whether participants receive payment or reimbursement.
- The registry does not report transportation, parking, lodging, or other travel support.
- The registry does not state whether any visits or assessments may be completed remotely.
- The registry does not state whether butyrate enemas are available after the 12-week intervention period.
Before contacting the site
Questions for the study team
- Which ulcerative colitis medicines may continue before and during the study, and which are covered by the four-week exclusion?
- How many study visits are required, where do they occur, and how long does each visit take?
- How many endoscopies are required, when are they performed, and are they research procedures or routine care?
- What happens if symptoms, disease activity, or inflammatory markers worsen during the study?
- What side effects or practical difficulties should families know about when using daily butyrate enemas?
- Which laboratory tests are performed, how often are samples collected, and does calprotectin testing require stool samples?
- Which costs are covered, and are compensation, parking, transportation, or other travel support available?
Before changing care
Questions for your gastroenterologist
- Would any changes to current ulcerative colitis treatment be medically appropriate if the study requires a four-week treatment restriction?
- How stable is the ulcerative colitis now, and what signs would indicate that study participation should be reconsidered with the research team?
- What approved treatment alternatives are available, and how do their known risks and monitoring needs compare with the study procedures?
- How should routine ulcerative colitis care, laboratory monitoring, and endoscopy be coordinated between you and the study team?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
Butyrate is an important metabolite produced by the gut microbiome and has been shown as a helpful therapy in ulcerative colitis. This is a feasibility study to determine the efficacy of butryate enemas in pediatric ulcerative colitis.
butyrate enemas will be administered for 12 weeks to children ages 7 to 21 with mild to moderate ulcerative colitis to determine if butyrate therapy can help improve the clinical disease in those children. standard management of the disease will be performed during these 12 weeks including routine laboratory studies and endoscopy.
Study design and administration
- Organization
- Children's Hospital Los Angeles
- Organization class
- Other
- Organization study ID
- CHLA-22-00049
- Lead sponsor
- Children's Hospital Los Angeles
- Sponsor class
- Other
- Enrollment type
- Estimated
- Allocation
- Na
- Intervention model
- Single Group
- Primary purpose
- Treatment
- Masking
- None
- Who is masked
- Not provided
- Standard age groups
- Child, Adult
Study arms
Experimental
open label intervention arm
Butyrate enemas will be administered once daily for twelve weeks.
Interventions: Drug: Butyrate
Interventions
Drug
Butyrate
Butyrate enemas will be administered once a day for 12 weeks
Eligibility
7 Years–21 Years
All
Not accepted
Inclusion criteria (1)
- 7-21 years, mild to moderate ulcerative colitisRegistry-derived · unreviewed
Exclusion criteria (2)
- UC therapy within 4 weeks of study medication initiationRegistry-derived · unreviewed
- infectious colitis, -pregnancyRegistry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
Primary outcome
Number of participants that experience pediatric ulcerative colitis activity index score <10.
Time frame: 12 weeks
pediatric ulcerative colitis activity index, remission is \<10, mild disease 10-34, moderate 35-64, severe 65 or greater
Secondary outcome
Number of participants with improvement to inflammatory markers using ESR, CRP, and Calprotectin
Time frame: 12 weeks
normalization or at least improvement of inflammatory markers described above
Recruiting locations in the United States
Children's Hospital Los Angeles
RecruitingLos Angeles, California, 90027, United States
Sonia Michail, MD(323) 361-1353sonia.michail@hotmail.com
Central study contacts
Registry dates
- First posted
- Feb 1, 2022
- Primary completion
- Jun 30, 2027
- Overall completion
- Jun 30, 2027
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.