Health TrialsbyHealthPanel

The Use of Butyrate Therapy in Pediatric Ulcerative Colitis

ConditionUlcerative Colitis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age7-21
SponsorChildren's Hospital Los Angeles

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

7-21 years, mild to moderate ulcerative colitis

Disqualifiers

UC therapy within 4 weeks of study medication initiation

infectious colitis, -pregnancy

Trial design

Design model

Single group

Treatments tested in this trial

  • Butyrate

    Drug

    Butyrate enemas will be administered once a day for 12 weeks

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: open label intervention armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants that experience pediatric ulcerative colitis activity index score <10.

pediatric ulcerative colitis activity index, remission is \<10, mild disease 10-34, moderate 35-64, severe 65 or greater

Time frame
12 weeks

Secondary outcomes

1

Number of participants with improvement to inflammatory markers using ESR, CRP, and Calprotectin

normalization or at least improvement of inflammatory markers described above

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Children's Hospital Los Angeles

Lead sponsor

Source ClinicalTrials.gov
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