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NCT05663060
Evaluation Study of the Intestinal Microbiota and Quality of Life in Patients Suffering From IBS Treated With Bifidice
Conditions: Irritable Bowel Syndrome
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 30
Sponsor: Istituto Clinico Humanitas
Location: Italy
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.
Eligibility Criteria
Inclusion Criteria:Patients aged ≥18 yearsDiagnosis of IBS according to Rome IV criteriaMild to moderate disease, as measured by FBDSIAbsence 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 practiceInformed consent expressed in written formExclusion Criteria:Patients undergoing surgical resection of the stomach, gallbladder, small or large intestineHistory of inflammatory bowel diseaseSevere SII, measured by FBDSIActive peptic ulcerHistory of ischemic colitisActive infectious enteritisDiagnosed with hypo- or hyperthyroidismNeed for pharmacological treatments for IBS, antibiotics, antidepressants and laxativesTherapy 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
Source: ClinicalTrials.gov (NCT05663060). StuddyBuddy aggregates publicly available trial information.