Effect of Lactibiane Tolerance® to Treat Leaky Gut in Irritable Bowel Syndrome With Predominant Diarrhea (IBS-D)Patients

Inclusion criteria

• ✓. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.
• ✓. Subjects are willing and able to participate in the study, complete subject assessments, attend scheduled clinic visits, and comply with all protocol requirements as evidenced by written informed consent.
• ✓. Male and/or female subjects between the ages of ≥18 and ≤75 years at the time of informed consent.
• ✓. Diagnosis of IBS following Rome IV criteria (Mearin et al., Gastroenterology 2016)\*: Recurrent abdominal pain, on average, at least 1 day per week in the last 3 months, associated with 2 or more of the following criteria:
• ✓. related with defecation
• ✓. associated with a change in frequency of stool
• ✓. onset associated with a change in form (appearance) of stool \* Criteria fulfilled for the last 3 months with symptom onset at least 6 months before diagnosis.
• ✓. Diagnosis of IBS with predominant diarrhea (IBS-D), following Rome IV criteria (Mearin et al., Gastroenterology 2016): more than one fourth (25%) of bowel movements with Bristol stool form types 6 or 7 and less than one-fourth (25%) of bowel movements with Bristol stool form types 1 or 2 or Patient reports that abnormal bowel movements are usually diarrhea (like type 6 or 7 in the picture of Bristol Stool Form Scale)