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Butyrate in Children With IBS: Double Blind Placebo Controlled Randomized Clinical Trial

NCT04566679 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2021-04-23

No results posted yet for this study

Summary

We will perform a randomized, double-blind, placebo-controlled trial to establish whether calcium butyrate relieves symptoms in children with irritable bowel syndrome (IBS). The direct effects of butyrate on inflammation and GI symptoms will be studied in children with IBS. The design used to study the effects of calcium butyrate will be a double blind randomized placebo-controlled parallel design.

Conditions

  • Irritable Bowel Syndrome (IBS)
  • Children, Only

Interventions

DIETARY_SUPPLEMENT

Dibuzin

2-week run-in phase (weeks 1-2) followed by 8-week treatment period (weeks 3-10) and 4-week follow-up phase (weeks 11-14)

DIETARY_SUPPLEMENT

placebo

2-week run-in phase (weeks 1-2) followed by 8-week treatment period (weeks 3-10) and 4-week follow-up phase (weeks 11-14)

Sponsors & Collaborators

  • University of Bari

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-21
Primary Completion
2023-01-01
Completion
2023-01-01

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04566679 on ClinicalTrials.gov