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Analysis of Microbiota Changes Induced by Microencapsulated Sodium Butyrate in Patients With Inflammatory Bowel Disease

NCT04879914 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2022-11-03

No results posted yet for this study

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.

Conditions

  • Inflammatory Bowel Diseases
  • Irritable Bowel Syndrome

Interventions

DIETARY_SUPPLEMENT

Butyrate

3 cps/die 300 mg/cps

DIETARY_SUPPLEMENT

Placebo

3 cps/die 300 mg/cps

Sponsors & Collaborators

  • University of Padova

    lead OTHER

Principal Investigators

  • Edoardo V. Savarino, Prof. MD, PhD · Department of Surgery, Oncology and Gastroenterology - DiSCOG University of Padua - Azienza Ospedaliera di Padova

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-01
Primary Completion
2022-06-30
Completion
2022-09-30

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 NCT04879914 on ClinicalTrials.gov