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

University of Padova

Status: Completed

Conditions: Irritable Bowel Syndrome; Inflammatory Bowel Diseases

Treatments: Dietary Supplement: Butyrate; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04879914

4049/AO/17

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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160 participants in 2 patient groups

Butyrate

Experimental group

Description:

Patients taking butyrate

Treatment:

Dietary Supplement: Butyrate

Placebo

Experimental group

Description:

Patients taking placebo

Treatment:

Dietary Supplement: Placebo