Status:
COMPLETED
Effect of Lactibiane Tolerance® to Treat Leaky Gut in Irritable Bowel Syndrome With Predominant Diarrhea (IBS-D)Patients
Lead Sponsor:
Larena SAS
Conditions:
IBS - Irritable Bowel Syndrome
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
This is a Phase IV, open-label, single-center, proof-of-concept, pilot study to evaluate the effect of Lactibiane Tolerance® in treating leaky gut in IBS-D patients. 30 consecutive patients with IBS-...
Detailed Description
Gut microbiota has many beneficial effects on the GI tract: barrier, immunomodulatory, metabolic, trophic among others. Microbiota unbalance or dysbiosis has been associated to digestive and extradige...
Eligibility Criteria
Inclusion
- Subjects must meet all of the following inclusion criteria to be eligible for enrolment into the study at baseline visit:
- 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)
- Evidence of a colonoscopy performed 5 years within the enrolment showing no evidence of organic disease
- Evidence of increased intestinal permeability at 51Cr-EDTA or 99mTc-DTPA assessment performed during screening phase.
Exclusion
- Subjects presenting with any of the following will not be included in the study:
- Subjects with suspect or evidence of organic disease, including but not limited to coeliac disease, inflammatory bowel disease, gastrointestinal neoplasia, unexplained anemia
- Subjects with a history of colonic or small bowel resection.
- Subjects with lactose intolerance
- Use of probiotics or antibiotics or investigational agents within 30 days before baseline
- Repeated use of anti-inflammatory drugs, including the non-steroidal anti-inflammatory drugs such as aspirin or ibuprofen within 7 days from the enrolment (except for prophylactic use of a stable dose of aspirin up to 325 mg / day for cardiac disease) and use of any product or ingredient that can have an effect on the intestinal permeability.
- Any major illness/condition or evidence of an unstable clinical condition (eg, renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, immunologic, or local active infection/infectious illness) that, in the investigator's judgement will substantially increase the risk to the subject if he or she participates in the study.
- Normal intestinal permeability at 51Cr-EDTA or 99mTc-DTPA assessment performed during screening
- Women during pregnancy or lactation.
Key Trial Info
Start Date :
May 17 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 25 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04898257
Start Date
May 17 2018
End Date
November 25 2020
Last Update
May 24 2021
Active Locations (1)
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1
Fondazione Policlinico Gemelli
Roma, RM, Italy, 00168