Evaluation Study of the Intestinal Microbiota and Quality of Life in Patients Suffering From IBS Treated With Bifidice (Bifidice01)

Evaluation Study of the Intestinal Microbiota and Quality of Life in Patients Suffering From Irritable Bowel Syndrome Treated With Bifidice

Irritable bowel syndrome is the most common functional gastrointestinal disease and is characterized by high prevalence and chronic course.The pathology has a strong impact on the quality of life of affected patients and on health and social costs, these related to reduced productivity.The scarce efficacy and heavy side effects of traditional therapies lead these patients to often resort to alternative or complementary therapies. From the evaluation of the evidence of various probiotic preparations and food supplements, the investigators have used a commercial preparation characterized by the presence of bifidobacteria which have demonstrated some efficacy in thinking of improving the quality of life of these patients to evaluate quality of life, ability productivity and trend of some indices of disease severity in a small number of patients. These preliminary data could represent a starting point for more in-depth evaluations, also with placebo-controlled studies.

Study Overview

• Status: Recruiting
• Conditions: Irritable Bowel Syndrome
• Intervention / Treatment: Drug: Probiotic Formula

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alessandro Repici, MD; Phone Number: 0039-02-82247493; Email: alessandro.repici@humanitas.it
• Study Contact Backup: Name: Vincenzo Craviotto, MD; Phone Number: 0039-02-82243113; Email: gaia.pellegatta@humanitas.it

Study Locations

• Italy
  • Milano, Italy, 20089
    • Recruiting
    • Humanitas Research Hospital
    • Contact: Alessandro Repici, MD; Phone Number: 0039-02-82244507; Email: alessandro.repici@hunimed.eu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients aged ≥18 years
• Diagnosis of IBS according to Rome IV criteria
• Mild to moderate disease, as measured by FBDSI
• Absence of signs and symptoms that may suggest organic damage and, if indicated, negative instrumental investigations (colonoscopy and/or imaging)
• Prescription of Bifidice, according to normal clinical practice
• Informed consent expressed in written form

Exclusion Criteria:

• Patients undergoing surgical resection of the stomach, gallbladder, small or large intestine
• History of inflammatory bowel disease
• Severe SII, measured by FBDSI
• Active peptic ulcer
• History of ischemic colitis
• Active infectious enteritis
• Diagnosed with hypo- or hyperthyroidism
• Need for pharmacological treatments for IBS, antibiotics, antidepressants and laxatives
• Therapy in progress with drug or supplements included in the list of those not allowed (Paragraph N: to be established)
• Any disease that may affect gastrointestinal function and could interfere with appropriate assessment of abdominal pain or discomfort

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Probiotic	Drug: Probiotic Formula; Probiotic Formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modification of teh intestinal microbiota	Analysis of faecal samples (Next Generation Sequencing analysis)	12 months

Collaborators and Investigators

• Sponsor: Istituto Clinico Humanitas

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2022
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: December 14, 2022
• First Submitted That Met QC Criteria: December 22, 2022
• First Posted (Estimate): December 23, 2022

Study Record Updates

• Last Update Posted (Estimate): December 23, 2022
• Last Update Submitted That Met QC Criteria: December 22, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome
• Other Study ID Numbers: 3291

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No