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

Not Applicable

Completed

• Conditions: Irritable Bowel Syndrome
• Interventions: Drug: Probiotic Formula

• Registration Number: NCT05663060
• Lead Sponsor: Istituto Clinico Humanitas

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-12
• Study Start: 2022-12-13
• Study First Submitted: 2022-12-14
• Study First Submitted QC: 2022-12-22
• Study First Posted: 2022-12-23
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Last Update Submitted: 2024-08-05
• Last Update Posted: 2024-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Probiotic	Probiotic Formula	Probiotic

Primary Outcome Measures

Name	Time	Method
Modification of teh intestinal microbiota	12 months	Analysis of faecal samples (Next Generation Sequencing analysis)

Trial Locations

Locations (1)

Humanitas Research Hospital; 🇮🇹 Milano, Italy