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

Last updated: November 2, 2022
Sponsor: University of Padova
Overall Status: Completed

Phase

N/A

Condition

Lactose Intolerance

Gastrointestinal Diseases And Disorders

Colic

Treatment

N/A

Clinical Study ID

NCT04879914
4049/AO/17
  • Ages 18-75
  • All Genders
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • (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.

Study Design

Total Participants: 160
Study Start date:
June 01, 2020
Estimated Completion Date:
September 30, 2022

Study Description

The IBDMicro is an interventional, randomized, double-blind, placebo-controlled study. A novel oral formulation of butyrate contained in a lipophilic microcapsule, that provides extensive capacity for intestinal diffusion and facilitates slow release of the active ingredient will be used ("Butyrose" produced by SILA SRL, Italy). A proof-of-concept study has been already published in this context, and preliminary data showed that butyrate administration was able to change the gut microbiota of patients with IBD and IBS-D after 12 weeks of treatment, in association with the changes of intestinal inflammation indexes (fecal calprotectin). In keeping, investigators will assess the microbiota before and after the butyrate administration. Also, clinical data will be collected by using validated disease-specific questionnaires (Rome IV and clinical indexes for IBD). Quality of life will be also recorded. The analysis of intestinal microbiota will be carried out by collecting a fecal sample and analyzed with metagenomics techniques.

Connect with a study center

  • Edoardo Vinvenzo Savarino

    Padua, 35128
    Italy

    Site Not Available

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