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

NCT04898257 | Completed

• 1 other identifier: PILEJE-Lactibiane Tolerance
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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-D and an increased intestinal permeability assessed by 51Cr-EDTA or 99mTc-DTPA will receive the multistrain probiotic Lactibiane Tolerance® 10 billion CFU 1 capsule twice a day (30 minutes before breakfast and 30 minutes before dinner) for 30 days treatment. At the end of treatment, patients will repeat intestinal permeability assessment by 51Cr-EDTA or 99mTc-DTPA.

Conditions

IBS - Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects with normal intestinal permeability assessed by 51Cr-EDTA or 99mTc-DTPA

  To demonstrate the effect of the multistrain probiotic Lactibiane Tolerance® in normalizing leaky gut in IBS-D patients

  30 days

Secondary Outcomes (7)

• Mean variation of scores of items evaluated by VAS-IBS questionnaire after treatment compared to baseline

  30 days

• Percentage of patients answering "yes" to the self-evaluation question: "Do you feel that your IBS symptoms have been satisfactory alleviated by this treatment?"

  30 days

• Mean concentration of serum zonulin before and after treatment

  30 days

• Mean score on Bristol Stool Scale before and after treatment

  30 days

• Proportions of patients with 6 and 7 on Bristol Stool scale before and after treatment

  30 days

Study Arms (1)

Lactibiane Tolerance®

OTHER

30 consecutive patients with IBS-D and an increased intestinal permeability assessed by 51Cr-EDTA or 99mTc-DTPA will receive the multistrain probiotic Lactibiane Tolerance® 10 billion CFU 1 capsule twice a day (30 minutes before breakfast and 30 minutes before dinner) for 30 days treatment. At the end of treatment, patients will repeat intestinal permeability assessment by 51Cr-EDTA or 99mTc-DTPA.

Dietary Supplement: Multistrain probiotic

Interventions

Multistrain probiotic DIETARY_SUPPLEMENT

After completion of screening phase, during baseline visit, eligible patients will be assigned to Lactibiane Tolerance® 10 billion CFU 1 capsule twice a day on an empty stomach (30 minutes before breakfast and 30 minutes before dinner).

Also known as: Lactibiane Tolerance®

Lactibiane Tolerance®

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Larena SAS: lead

Study Sites (1)

Fondazione Policlinico Gemelli

Roma, RM, 00168, Italy

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Samira Aït Abdellah

  Laboratoire PILEJE

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 6, 2021
• First Posted: May 24, 2021
• Study Start: May 17, 2018
• Primary Completion: October 8, 2020
• Study Completion: November 25, 2020
• Last Updated: May 24, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)