Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2013-06-30
2022-06-30
Brief Summary
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Detailed Description
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This was a prospective, randomized, placebo-controlled multicentre study. Patients aged 6-18 years with colonic Crohn's disease or ulcerative colitis, who received standard therapy depending on the disease's severity, were randomized to receive 150 mg sodium butyrate twice a day (group A) or placebo (group B). The primary outcome was the difference in disease activity and fecal calprotectin concentration between the two study groups measured at 12 weeks of the study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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group A
150 mg sodium butyrate twice a day for 12 weeks
sodium butyrate
add-on therapy irrespective of standard treatment depending on severity (according to the guidelines)
group B
placebo capsules twice a day for 12 weeks
placebo
placebo
Interventions
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sodium butyrate
add-on therapy irrespective of standard treatment depending on severity (according to the guidelines)
placebo
placebo
Eligibility Criteria
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Inclusion Criteria
* newly diagnosed, based on the modified Porto criteria, IBD with colon involvement;
* informed consent of the child's parents or guardians to participate in the study.
Exclusion Criteria
* taking probiotics or dietary supplements in the last 2 weeks prior to study enrollment;
* lack of consent of parents or guardians to participate in the study.
6 Years
18 Years
ALL
No
Sponsors
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Centre of Postgraduate Medical Education
OTHER
Responsible Party
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Other Identifiers
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nr 41/2013
Identifier Type: -
Identifier Source: org_study_id
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