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Clinical trial

Butyrate Therapy in Hispanic Children With Ulcerative Colitis

ID
Name
CHLA-22-00049
Description
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.
Trial arms
Trial start
2022-06-29
Estimated PCD
2027-06-30
Trial end
2027-06-30
Status
Recruiting
Phase
Early phase I
Treatment
Butyrate
Butyrate enemas will be administered once a day for 12 weeks
Arms:
open label intervention arm
Other names:
Butyrate enemas
Size
10
Primary endpoint
remission of clinical disease
12 weeks
Eligibility criteria
Inclusion Criteria: * 7-21 years, mild to moderate ulcerative colitis Exclusion Criteria: * UC therapy within 4 weeks of study medication initiation * infectious colitis, -pregnancy
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 10, 'type': 'ESTIMATED'}}
Updated at
2024-04-18

1 organization

1 product

1 indication

Organization
Children's Hospital Los Angeles
Product
Butyrate
Indication
ulcerative colitis