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

Not Applicable

Completed

• Conditions: Irritable Bowel Syndrome; Inflammatory Bowel Diseases
• Interventions: Dietary Supplement: Butyrate; Dietary Supplement: Placebo

• Registration Number: NCT04879914
• Lead Sponsor: University of Padova

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.

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.

Study Timeline

• Study Start: 2020-06-01
• Study First Submitted: 2021-04-27
• Study First Submitted QC: 2021-05-04
• Study First Posted: 2021-05-10
• Status Verified: 2021-09
• Primary Completion: 2022-06-30
• Study Completion: 2022-09-30
• Last Update Submitted: 2022-11-02
• Last Update Posted: 2022-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Butyrate	Butyrate	Patients taking butyrate
Placebo	Placebo	Patients taking placebo

Primary Outcome Measures

Name	Time	Method
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.	90 days	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.

Secondary Outcome Measures

Name	Time	Method
Treatment effects on clinical activity by fecal calprotectin.	90 days	Analysis of fecal calprotectin will be evaluated by clinical routinary analysis before and after treatment with Butyrose/Placebo. The Butyrose treatment at the dose of 3 capsules/die, will be administered in consecutive IBD and IBS-D patients, for 90 days. At the same time, a control group received three starch capsules with similar color, flavor, and size.
Treatment effects on lifestyle by IBD Questionaire.	90 days	The IBD questionnaire is a disease-specific questionnaire to highlight the patients' lifestyle before and after treatment. The IBDQ analysis will be performed as described in Yarlas A. et al.;J Patient Cent Res Rev 2020 10.17294/2330-0698.1722

Trial Locations

Locations (1)

Edoardo Vinvenzo Savarino; 🇮🇹 Padua, Italy