Efficacy and Safety of Oral Administration of Postibiotic by FOS Fermentation From Lactobacillus Paracasei in the Treatment of Irritable Bowel Syndrome.

Launched by ISTITUTO CLINICO HUMANITAS · May 15, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for Irritable Bowel Syndrome (IBS), a common condition that affects the digestive system and can significantly impact people's daily lives. The trial will investigate a product called post-biotic, derived from a type of bacteria named Lactobacillus paracasei, which may help improve gut health and relieve IBS symptoms. Currently, there isn’t a standardized treatment for IBS, so researchers are hopeful that this new approach could offer better options for patients.

To participate in this trial, individuals must be between 18 and 75 years old and have a confirmed diagnosis of IBS. They should have mild to moderate symptoms, as assessed by a questionnaire, and must be able to follow the study procedures. Participants should also have a stable diet and must not be pregnant or nursing. Throughout the trial, participants can expect to take the post-biotic product and provide feedback on their symptoms. It’s important to note that individuals with certain medical conditions or those taking specific medications may not be eligible to join the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 18-75 years
• • IBS diagnosis according to ROME IV criteria
• • Mild-moderate disease defined by IBS-SSS questionnaire at the baseline visit and after the washout period
• • Signed Informed Consent
• • Patients' ability to comply with the study procedures
• • Stable diet within two months prior to the screening visit
• • Negative colonoscopy (only \> 50 years old patients)
• Exclusion Criteria:
• • Therapy with drugs or supplements included in the prohibited list
• • Malignancy or history of malignancy, except patients with a history of surgically removed extraintestinal malignancy and a 5-year disease-free interval
• • Unstable psychiatric pathology
• • Organic bowel disease
• • Major abdominal surgery, except appendectomy and cholecystectomy
• • Relevant organic, systemic, metabolic pathologies or significant laboratory test abnormalities
• • Pregnant or nursing women
• • Patients with known hypersensitivity to one or more components of the product