Irritable bowel syndrome with predominant diarrhea (IBS-D) Digestive System
Conditions
Interventions
The active product is a food supplement containing a multi-strain probiotic formulation (Serobioma), composed of Bifidobacterium longum BB536, Bifidobacterium lactis BL-04, and Lactobacillus rhamnosus
Sponsors
Bromatech SRL
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Healthy male and female subjects 2. Subjects of Caucasian ethnicity 3. Subjects aged between 18 and 64 years (extremes included)* 4. Subjects with Irritable Bowel Syndrome with predominant diarrhea (IBS-D)** 5. Subjects registered with national health service 6. Subjects certifying the truthfulness of the personal data disclosed to the investigator 7. Subjects able to understand the language used in the investigation center and the information given by the investigator 8. Subjects able to respect the instructions given by the investigator as well as able to respect the study constraints and specific requirements 9. Subjects who commit not to change their daily routine or lifestyle during the experimental phase *** 10. Subjects on stable pharmacological therapy (except therapies listed under the non-inclusion criteria) for at least one month, with no changes expected or planned during the study 11. Subjects informed about the test procedures who have signed a consent form and privacy agreement *If the subject is older than 50 years, they must have undergone a colonoscopy with a negative result within the previous 5 years **Assessed by the gastroenterologist using Rome IV criteria diagnostic criteria for Irritable Bowel Syndrome: Recurrent abdominal pain on average at least 1 day per week in the last 3 months, with symptom onset at least 6 months prior to diagnosis (prior to the experimental phase. i.e washout period), associated with two or more of the following: related to defecation, associated with a change in frequency of stool, associated with a change in form (appearance) of stool For the classification of the subtype Irritable Bowel Syndrome with predominant diarrhea (IBS-D): > ¼ (25%) of bowel movements with Bristol stool types 6 or 7; < ¼ (25%) of bowel movements with Bristol stool types 1 or 2. ***Subjects will keep a weekly diary where they will record their eating habits. This diary will be collected during the washout period and during the following weeks while taking the product.
Exclusion criteria
Exclusion criteria: 1. Subjects who do not meet the inclusion criteria 2. Subjects with any acute, chronic, or progressive disease or condition that may interfere with the study data or that the investigator considers dangerous to the subject or incompatible with the requirements of the study**** 3. Subjects participating or planning to participate in other clinical trials 4. Subjects who participated in a similar study without respecting an adequate washout period (at least one month) 5. Subjects who have food intolerances or food allergies to ingredients of the study product 6. Subjects under pharmacological treatments that are considered incompatible with the study requirement by the investigator***** 7. Subjects who are currently using food supplement(s) and/or products with the same activity as the study product, or who haven't observed an adequate washout period (at least one month) 8. Subjects admitted to a health or social facility 9. Subjects planning a hospitalization during the study 10. Subjects not able to be contacted in case of emergency 11. Subjects deprived of freedom by administrative or legal decision or under guardianship 12. Subjects who have or have had a history of alcohol or drug addiction 13. Subjects with eating disorders (i.e. bulimia, psychogenic eating disorders, etc.) 14. Subject breastfeeding, pregnant or not willing to take necessary precautions to avoid pregnancy during the study (for the women of childbearing potential) ****Including IBS-C, IBS-M, or IBS-U (according to the Rome IV criteria); alarm signs requiring further investigations (unexplained weight loss in the past 6 months, unexplained anemia, nocturnal symptoms, or blood in the stool except when due to hemorrhoids); inflammatory, autoimmune, or other organic gastrointestinal diseases (ulcerative colitis, Crohn’s disease, microscopic or ischemic colitis, celiac disease); intestinal infections; lactose intolerance; and any relevant organic, systemic, or metabolic conditions, as well as active malignant neoplasms or a history of malignancy with signs of recurrence within the previous 5 years. *****Including major abdominal surgical procedures; use of probiotics or antibiotic therapy within the last month; frequent use of stimulant (contact) laxatives; incompatible pharmacological treatments (e.g., metformin, antihypertensive sartans, SSRI antidepressants).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of bowel evacuation (n) measured using a diary at baseline, 28 and 56 days;Stool status measured using the Bristol Stool Form Scale (BSFS) (score from 1 to 7) at baseline, 28 and 56 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Product acceptability measured using self-evaluation questionnaire (polytomous question with four possible answers) at 14, 28 and 56 days of product use | — |
Countries
Italy
Contacts
Public ContactRoberta Villa
Outcome results
None listed