NCT04879914

Brief Summary

Inflammatory bowel disease (IBD) is characterized by severe inflammation of the small bowel and/or the colon leading to recurrent diarrhea and abdominal pain. Irritable Bowel Syndrome with diarrhea (IBS-D) is characterized by abdominal pain or discomfort, gas, loose and frequent stools. Butyrate has shown anti-inflammatory and regenerative properties, providing symptomatic relief when orally supplemented in patients suffering from various colonic diseases. The investigator proposes to investigate the effect of a microencapsulated form of sodium butyrate on the fecal microbiota of patients with IBD and IBS-D.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

June 1, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 10, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

November 3, 2022

Status Verified

September 1, 2021

Enrollment Period

2.1 years

First QC Date

April 27, 2021

Last Update Submit

November 2, 2022

Conditions

Inflammatory Bowel DiseasesIrritable Bowel Syndrome

Keywords

IBDMicrobiotaButyrateIBS

Outcome Measures

Primary Outcomes (1)

  • NGS analysis ( 16S rRNA) will be used to highlight the microbiota variation induced by Butyrose/Placebo administration in 160 IBD and 40 IBS-D patients after 8 weeks of treatment.

    The 16S rRNA is a fundamental component of the prokaryotic ribosome, where defines structural and functional properties interacting for example with the mRNA. Its structure and sequences were characterized during the 70's/80's, and the corresponding DNA coding sequence is referred to 16s rRNA gene. The 16s rRNA gene started to be used as the phylogenetic marker in the 70's due to its ubiquity among bacterial kingdom, allowing comparison between evolutionarily distant organisms. A new oral formulation of sodium-butyrate, at the dose of 3 capsules/d (1800 mg/d), will be administered, during the main meals, in consecutive IBD or IBS-D patients, for 90 days. At the same time, a control group will receive three starch capsules with similar color, flavor, and size.

    90 days

Secondary Outcomes (2)

  • Treatment effects on clinical activity by fecal calprotectin.

    90 days

  • Treatment effects on lifestyle by IBD Questionaire.

    90 days

Study Arms (2)

Butyrate

EXPERIMENTAL

Patients taking butyrate

Dietary Supplement: Butyrate

Placebo

EXPERIMENTAL

Patients taking placebo

Dietary Supplement: Placebo

Interventions

ButyrateDIETARY_SUPPLEMENT

3 cps/die 300 mg/cps

Also known as: Butyrose
Butyrate
PlaceboDIETARY_SUPPLEMENT

3 cps/die 300 mg/cps

Also known as: starch
Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with histologically confirmed diagnosis of Crohn disease (CD) or Ulcerative colitis (UC) in the last 6 months and undergoing followup colonoscopy.

You may not qualify if:

  • (a) prior proctocolectomy;
  • (b) presence of IBD extraintestinal manifestation;
  • (c) treatment with antibiotics in the last 60 days;
  • (d) extensive surgical resection;
  • (e) presence of stoma.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Edoardo Vinvenzo Savarino

Padua, 35128, Italy

Location

Related Publications (2)

  • Facchin S, Vitulo N, Calgaro M, Buda A, Romualdi C, Pohl D, Perini B, Lorenzon G, Marinelli C, D'Inca R, Sturniolo GC, Savarino EV. Microbiota changes induced by microencapsulated sodium butyrate in patients with inflammatory bowel disease. Neurogastroenterol Motil. 2020 Oct;32(10):e13914. doi: 10.1111/nmo.13914. Epub 2020 May 31.

    PMID: 32476236RESULT

  • Facchin S, Calgaro M, Pandolfo M, Buda A, Barberio B, Zingone F, Vitulo N, Savarino EV. Impact of oral butyrate on clinical and biochemical parameters in IBD: A randomized placebo-controlled study targeting gut microbiota. Dig Liver Dis. 2026 Jan;58(1):64-73. doi: 10.1016/j.dld.2025.11.014. Epub 2025 Dec 6.

    PMID: 41354580DERIVED

MeSH Terms

Conditions

Inflammatory Bowel DiseasesIrritable Bowel Syndrome

Interventions

ButyratesStarch

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColonic Diseases, FunctionalColonic Diseases

Intervention Hierarchy (Ancestors)

Acids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty Acids, VolatileFatty AcidsLipidsGlucansBiopolymersPolymersMacromolecular SubstancesDietary CarbohydratesCarbohydratesPolysaccharides

Study Officials

  • Edoardo V. Savarino, Prof. MD, PhD

    Department of Surgery, Oncology and Gastroenterology - DiSCOG University of Padua - Azienza Ospedaliera di Padova

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2021

First Posted

May 10, 2021

Study Start

June 1, 2020

Primary Completion

June 30, 2022

Study Completion

September 30, 2022

Last Updated

November 3, 2022

Record last verified: 2021-09

Locations

IT(1)