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

Irritable Bowel Syndrome Clinical Trial

— Bifidice01  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05663060
• Other study ID #: 3291
• Status: Recruiting
• Phase: N/A
• Start date: December 13, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: December 2022
• Source: Istituto Clinico Humanitas
• Contact: Alessandro Repici, MD
• Phone: 0039-02-82247493
• Email: alessandro.repici[@]humanitas.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

Drug:
• Probiotic Formula
Probiotic Formula

Locations

Country	Name	City	State
Italy	Humanitas Research Hospital	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modification of teh intestinal microbiota	Analysis of faecal samples (Next Generation Sequencing analysis)	12 months