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

NCT05663060 | Completed

• 1 other identifier: 3291
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• Modification of teh intestinal microbiota

  Analysis of faecal samples (Next Generation Sequencing analysis)

  12 months

Study Arms (1)

Probiotic

EXPERIMENTAL

Probiotic

Drug: Probiotic Formula

Interventions

Probiotic Formula DRUG

Probiotic Formula

Probiotic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

Study Sites (1)

Humanitas Research Hospital

Milan, 20089, Italy

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2022
• First Posted: December 23, 2022
• Study Start: December 13, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: August 6, 2024

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)