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

Sponsor

University of Padova (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04879914

Collaborator

(none)

200

Enrollment

Location

Arms

Anticipated Duration (Months)

7.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Inflammatory Bowel Diseases Irritable Bowel Syndrome	Dietary Supplement: Butyrate Dietary Supplement: Placebo	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Inflammation and Intestinal Microbiota Modulation in Inflammatory Bowel Diseases

Actual Study Start Date :

Jun 1, 2020

Actual Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Sep 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Butyrate Patients taking butyrate	Dietary Supplement: Butyrate 3 cps/die 300 mg/cps Other Names: Butyrose
Experimental: Placebo Patients taking placebo	Dietary Supplement: Placebo 3 cps/die 300 mg/cps Other Names: starch

Arm

Intervention/Treatment

Experimental: Butyrate

Patients taking butyrate

Dietary Supplement: Butyrate

3 cps/die 300 mg/cps

Other Names:

Butyrose

Experimental: Placebo

Patients taking placebo

Dietary Supplement: Placebo

3 cps/die 300 mg/cps

Other Names:

starch

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Edoardo Vinvenzo Savarino	Padua		Italy	35128

Sponsors and Collaborators

University of Padova

Investigators

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