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

Primary Purpose

Irritable Bowel Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Probiotic Formula
Sponsored by
Istituto Clinico Humanitas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Humanitas Research HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Probiotic

Arm Description

Probiotic

Outcomes

Primary Outcome Measures

Modification of teh intestinal microbiota
Analysis of faecal samples (Next Generation Sequencing analysis)

Secondary Outcome Measures

Full Information

First Posted
December 14, 2022
Last Updated
December 22, 2022
Sponsor
Istituto Clinico Humanitas
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1. Study Identification

Unique Protocol Identification Number
NCT05663060
Brief Title
Evaluation Study of the Intestinal Microbiota and Quality of Life in Patients Suffering From IBS Treated With Bifidice
Acronym
Bifidice01
Official Title
Evaluation Study of the Intestinal Microbiota and Quality of Life in Patients Suffering From Irritable Bowel Syndrome Treated With Bifidice
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 13, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Clinico Humanitas

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Probiotic
Arm Type
Experimental
Arm Description
Probiotic
Intervention Type
Drug
Intervention Name(s)
Probiotic Formula
Intervention Description
Probiotic Formula
Primary Outcome Measure Information:
Title
Modification of teh intestinal microbiota
Description
Analysis of faecal samples (Next Generation Sequencing analysis)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alessandro Repici, MD
Phone
0039-02-82247493
Email
alessandro.repici@humanitas.it
First Name & Middle Initial & Last Name or Official Title & Degree
Vincenzo Craviotto, MD
Phone
0039-02-82243113
Email
gaia.pellegatta@humanitas.it
Facility Information:
Facility Name
Humanitas Research Hospital
City
Milano
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alessandro Repici, MD
Phone
0039-02-82244507
Email
alessandro.repici@hunimed.eu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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