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

April 21, 2021 updated by: Ruggiero Francavilla, University of Bari
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Randomization Enrolled children will be randomly assigned, with the use of a computer-generated randomization list to receive either oral butyrate (500 mg) or oral placebo once (twice) per day. Placebo and butyrate had the same shape, the placebo's taste, dimension, indication, and appearance.

Data Collection A diary will be given to the parents; on a daily basis, patients will monitor and record the frequency/severity of symptoms and school absence on the diary. To assess the severity of pain, a combination of the self-reported visual analog scale (VAS) and the Faces Pain Scale (FPS) will be used. The 0- to 10-mm VAS scale (0, no pain; 10, worst possible pain) include a horizontal color gradient (green to red) plus a rating. Daily, when asked to evaluate pain, the child would point to a level and trace a line. Assessment will be done coupling the VAS with the FPS, which consists of 6 faces that range from a relaxed face to a face that shows intense pain (von Baeyer CL). GSRS Participants will be asked to fill out the GSRS every 2 weeks during running in, treatment, and follow up (Svedlund).

Compliance To ensure compliance, the investigator will contact the families every 4 weeks to monitor the process of the study.

Adherence will be assessed by counting the number of capsules returned; children who will miss taking more than 20% of the medication will be considered noncompliant.

Fecal Analysis Fecal samples for microbiological analysis will be collected before treatment and at week 10 (end of treatment) and week 14 (4 weeks after discontinuation). Urinary NMR Analysis Urinary samples for NMR analysis will be collected before treatment and at week 10 (end of treatment) and week 14 (4 weeks after discontinuation). This method is described by Lussu et al .

Fecal lactoferrin and calprotectin Fecal calprotectin will be measured using a commercial Fecal Calprotectin Immunoassay kit (Genova Diagnostics, Asheville, NC), respectively, following the manufacturers' instructions.

Sample size calculation To demonstrate an efficacy of butyrate, considering a placebo effect of 20% and a difference in response of at least 35%, keeping a power of the study of 80% and a p of 0,05 we need 23 patients for group that, considering a drop out of 10%, will became 25 per group.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Ba
      • Bari, Ba, Italy, 70126
        • Recruiting
        • Pediatric Department "B Trambusti" Ospedale Giovanni XXIII Via Amendola 270
        • Contact:
        • Principal Investigator:
          • Ruggiero Francavilla, MD
        • Sub-Investigator:
          • Fernanda Cristofori, MD
    • Puglia
      • Bari, Puglia, Italy, 70125
        • Recruiting
        • Clinica Pediatrica
        • Contact:
        • Principal Investigator:
          • Ruggiero Francavilla, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of IBS according to the Rome IV diagnostic criteria

Exclusion Criteria:

  • Presence of any chronic diseases
  • Treatment with antibiotics/prebiotics/probiotic/postbiotic in the previous two months
  • Diagnosis of another functional GI disease
  • Growth failure or others alarming signs of organic conditions
  • Previous abdominal surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Butyrate
oral butyrate (500mg) once or twice per day
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)
Placebo Comparator: Placebo
oral placebo once or twice per day
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
butyrate on GI symptoms
Time Frame: daily for 14 weeks
To assess the severity of pain, a combination of the self-reported visual analog scale (VAS) and the Faces Pain Scale (FPS) will be used. The 0- to 10-mm VAS scale (0, no pain; 10, worst possible pain) include a horizontal color gradient (green to red) plus a rating.
daily for 14 weeks
butyrate on GI symptoms
Time Frame: every two weeks for 14 weeks
Gastrointestinal Symptom Rating Scale (GSRS)
every two weeks for 14 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
butyrate on inflammation
Time Frame: 14 weeks
fecal calprotectin and lactoferrin
14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bari

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 21, 2021

Primary Completion (Anticipated)

January 1, 2023

Study Completion (Anticipated)

January 1, 2023

Study Registration Dates

First Submitted

September 18, 2020

First Submitted That Met QC Criteria

September 25, 2020

First Posted (Actual)

September 28, 2020

Study Record Updates

Last Update Posted (Actual)

April 23, 2021

Last Update Submitted That Met QC Criteria

April 21, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BUZIR2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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