NCT04566679

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 28, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

April 21, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

April 23, 2021

Status Verified

April 1, 2021

Enrollment Period

1.7 years

First QC Date

September 18, 2020

Last Update Submit

April 21, 2021

Conditions

Irritable Bowel Syndrome (IBS)Children, Only

Keywords

Irritable Bowel Syndrome (IBS)children

Outcome Measures

Primary Outcomes (2)

  • butyrate on GI symptoms

    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

    Gastrointestinal Symptom Rating Scale (GSRS)

    every two weeks for 14 weeks

Secondary Outcomes (1)

  • butyrate on inflammation

    14 weeks

Study Arms (2)

Butyrate

EXPERIMENTAL

oral butyrate (500mg) once or twice per day

Dietary Supplement: Dibuzin

Placebo

PLACEBO COMPARATOR

oral placebo once or twice per day

Dietary Supplement: placebo

Interventions

DibuzinDIETARY_SUPPLEMENT

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)

Butyrate
placeboDIETARY_SUPPLEMENT

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

Eligibility Criteria

Age4 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Diagnosis of IBS according to the Rome IV diagnostic criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Clinica Pediatrica

Bari, Apulia, 70125, Italy

RECRUITING

Pediatric Department "B Trambusti" Ospedale Giovanni XXIII Via Amendola 270

Bari, Ba, 70126, Italy

RECRUITING

Related Publications (10)

  • Gibson P, Rosella O. Interleukin 8 secretion by colonic crypt cells in vitro: response to injury suppressed by butyrate and enhanced in inflammatory bowel disease. Gut. 1995 Oct;37(4):536-43. doi: 10.1136/gut.37.4.536.

    PMID: 7489942RESULT

  • Ogawa H, Rafiee P, Fisher PJ, Johnson NA, Otterson MF, Binion DG. Butyrate modulates gene and protein expression in human intestinal endothelial cells. Biochem Biophys Res Commun. 2003 Sep 26;309(3):512-9. doi: 10.1016/j.bbrc.2003.08.026.

    PMID: 12963019RESULT

  • Pozuelo M, Panda S, Santiago A, Mendez S, Accarino A, Santos J, Guarner F, Azpiroz F, Manichanh C. Reduction of butyrate- and methane-producing microorganisms in patients with Irritable Bowel Syndrome. Sci Rep. 2015 Aug 4;5:12693. doi: 10.1038/srep12693.

    PMID: 26239401RESULT

  • Zhu L, Ma Y, Ye S, Shu Z. Acupuncture for Diarrhoea-Predominant Irritable Bowel Syndrome: A Network Meta-Analysis. Evid Based Complement Alternat Med. 2018 May 27;2018:2890465. doi: 10.1155/2018/2890465. eCollection 2018.

    PMID: 29977312RESULT

  • Banasiewicz T, Krokowicz L, Stojcev Z, Kaczmarek BF, Kaczmarek E, Maik J, Marciniak R, Krokowicz P, Walkowiak J, Drews M. Microencapsulated sodium butyrate reduces the frequency of abdominal pain in patients with irritable bowel syndrome. Colorectal Dis. 2013 Feb;15(2):204-9. doi: 10.1111/j.1463-1318.2012.03152.x.

    PMID: 22738315RESULT

  • von Baeyer CL. Children's self-reports of pain intensity: scale selection, limitations and interpretation. Pain Res Manag. 2006 Autumn;11(3):157-62. doi: 10.1155/2006/197616.

    PMID: 16960632RESULT

  • Svedlund J, Sjodin I, Dotevall G. GSRS--a clinical rating scale for gastrointestinal symptoms in patients with irritable bowel syndrome and peptic ulcer disease. Dig Dis Sci. 1988 Feb;33(2):129-34. doi: 10.1007/BF01535722.

    PMID: 3123181RESULT

  • Lussu M, Noto A, Masili A, Rinaldi AC, Dessi A, De Angelis M, De Giacomo A, Fanos V, Atzori L, Francavilla R. The urinary 1 H-NMR metabolomics profile of an italian autistic children population and their unaffected siblings. Autism Res. 2017 Jun;10(6):1058-1066. doi: 10.1002/aur.1748. Epub 2017 Mar 11.

    PMID: 28296209RESULT

  • De Angelis M, Piccolo M, Vannini L, Siragusa S, De Giacomo A, Serrazzanetti DI, Cristofori F, Guerzoni ME, Gobbetti M, Francavilla R. Fecal microbiota and metabolome of children with autism and pervasive developmental disorder not otherwise specified. PLoS One. 2013 Oct 9;8(10):e76993. doi: 10.1371/journal.pone.0076993. eCollection 2013.

    PMID: 24130822RESULT

  • Cristofori F, Calabrese FM, Iacobellis I, Santamaria M, Celano G, Ferrocino I, Di Sabato E, Pergola R, Dargenio VN, Paulucci L, De Angelis M, Francavilla R. Calcium butyrate efficacy in pediatric irritable bowel syndrome: Randomized placebo-controlled multiomics-based clinical trial. J Pediatr Gastroenterol Nutr. 2025 Sep;81(3):551-561. doi: 10.1002/jpn3.70154. Epub 2025 Jul 9.

    PMID: 40635319DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 18, 2020

First Posted

September 28, 2020

Study Start

April 21, 2021

Primary Completion

January 1, 2023

Study Completion

January 1, 2023

Last Updated

April 23, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

IT(2)