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

Istituto Clinico Humanitas

Status

Completed

Conditions

Irritable Bowel Syndrome

Treatments

Drug: Probiotic Formula

Study type

Interventional

Funder types

Other

Identifiers

NCT05663060

3291

Details and patient eligibility

About

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.

Enrollment

8 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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