NCT04879914

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

Inflammation and Intestinal Microbiota Modulation in Inflammatory Bowel Diseases

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: University of Padova · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Inflammatory Bowel Diseases
• Irritable Bowel Syndrome

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Butyrate	3 cps/die 300 mg/cps
DIETARY_SUPPLEMENT	Placebo	3 cps/die 300 mg/cps

Timeline

• Start date: 2020-06-01
• Primary completion: 2022-06-30
• Completion: 2022-09-30
• First posted: 2021-05-10
• Last updated: 2022-11-03

Locations

1 site across 1 country: Italy