L. Casei DG® in Patients With Irritable Bowel Syndrome. (PROBE2)

May 5, 2022 updated by: SOFAR S.p.A.

L. Casei DG® (Lactobacillus Paracasei CNCMI1572) in the Treatment of Patients With Irritable Bowel Syndrome: a Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo Controlled Study.

To assess the effect of L. casei DG® (Lactobacillus paracasei CNCMI1572; Enterolactis® plus) on abdominal symptoms and gut microbiota metabolism/composition in non constipated patients with IBS (Irritable Bowel Syndrome). Patients will be randomized to receive L. casei DG® capsules, b.i.d. for 12 weeks the a 4 weeks Follow Up period will follow.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

264

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bari, Italy
        • Gastroenterologia Universitaria Policlinico Giovanni XXIII
      • Belluno, Italy
        • Azienda ULSS 1
      • Bologna, Italy, 40100
        • Azienda Ospedaliero-Universitaria S. Orsola Malpighi
      • Chieti, Italy
        • Ospedale Ss. Annunziata
      • Milano, Italy
        • Fondazione IRCCS Policlinico
      • Napoli, Italy
        • Policlinico Federico II
      • Napoli, Italy, 80100
        • Policlinico
      • Padova, Italy
        • Azienda Ospedaliera di Padova
      • Pavia, Italy
        • Fondazione IRCCS Policlinico S. Matteo
      • Pisa, Italy
        • U.O. Gastroenterologia Universitaria
      • Roma, Italy, 00128
        • Policlinico Universitario Campus Biomedico
      • Roma, Italy
        • A.O. San Camillo-Forlanini
      • Roma, Italy
        • Ospedale Sant'Andrea
    • BG
      • Seriate, BG, Italy
        • A.O. Bolognini
    • CA
      • Cagliari, CA, Italy
        • A.O. "G. Brotzu"- Ospedale San Michele
      • Cagliari, CA, Italy
        • AOU di Cagliari - Policlinico di Monserrato
    • CO
      • Como, CO, Italy
        • Ospedale Valduce
    • MI
      • Milano, MI, Italy
        • ASST-FTB-Sacco
      • San Donato Milanese, MI, Italy
        • Policlínico San Donato
    • VC
      • Vercelli, VC, Italy
        • Ospedale Sant'Andrea

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age > 18 years and ≤ 65 years
  • A positive diagnosis of non constipated IBS (i.e., IBS-D and IBS-M, both males and females), according to Rome IV criteria.

  • A negative outcome of colonoscopy performed within 5 years before screening if patient is at least 50 years old, or if patient meet any of the following alarm features:

    1. Has a documented weight loss within the past 6 months; or
    2. Has nocturnal symptoms; or
    3. Has a familiar history of colon cancer; or
    4. Has blood mixed with their stool (excluding blood from hemorroids).
  • Negative relevant additional screening or consultation whenever appropriate
  • Ability to conform to the study protocol.

Exclusion Criteria:

  • Patients with IBS-C or IBS-U according to Rome IV criteria
  • Presence of any relevant organic, systemic or metabolic disease (particularly significant history of cardiac, renal, neurological, psychiatric, oncology, endocrinology, metabolic or hepatic disease), or abnormal laboratory values that will be deemed clinically significant on the basis of predefined values, (i.e..liver or kidney functional levels 2-times greater than the upper reference values)
  • Ascertained intestinal organic diseases, including celiac disease, food allergies or inflammatory bowel diseases (Crohn's disease, ulcerative colitis, diverticular disease, infectious colitis, ischemic colitis, microscopic colitis).
  • Previous major abdominal surgery.
  • Active malignancy of any type, or history of a malignancy (patients with a history of other malignancies that have been surgically removed and who have no evidence of recurrence for at least five years before study enrolment are also acceptable).
  • Untreated food intolerance such as ascertained or suspected lactose intolerance, as defined by anamnestic evaluation or, if appropriate, lactose breath test.
  • Use of probiotics or topical and/or systemic antibiotic therapy during the last month.
  • Systematic/frequent use of contact laxatives.
  • Pregnant females or females of childbearing potential in the absence of effective contraceptive methods.
  • Inability to conform to protocol.
  • Treatment with any investigational drug within the previous 30 days.
  • Recent history or suspicion of alcohol abuse or drug addiction.
  • Presence of red or white flags at the Rome IV Psychosocial Alarm Questionnaire for Functional gastrointestinal Disorders.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: L. casei DG®

Interventions: Lactobacillus paracasei CNCMI1572 (At least 24 billion live cells per capsule)

1 capsule, b.i.d. for 12 weeks
Dietary supplement: L.casei DG

(At least 24 billion live cells per capsule)

1 capsule, b.i.d. for 12 weeks
Placebo Comparator: Placebo

Interventions : capsules for oral use, indistinguishable from active product.

1 capsule, b.i.d. for 12 weeks
Dietary supplement: PLACEBO
1 capsule, b.i.d. for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients who have a response in pain
Time Frame: 12 weeks
Patients who record on ≥ 50% of the days a reduction of ≥ 30% from their average baseline score for their worst abdominal pain.The standard 11-point numeric rating scale (from 0=none to 10=worst possible pain) will be used to measure abdominal pain.
12 weeks
Proportion of patients who have a response in stool consistencies
Time Frame: 12 weeks
Patients who record a stool-consistency score < 5 in the same days in which they record a reduction of ≥ 30% from their average baseline score for their worst abdominal pain .For abnormal defecation, stool frequency and form will be measured using the Bristol Stool Form Scale (BSFS).
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of Pain relief
Time Frame: 16 weeks
reduction of ≥ 30% from baseline in the score for the worst abdominal pain on ≥ 50% of days
16 weeks
Evaluation of global symptom score
Time Frame: 16 weeks
Improvement in the global symptom score: a score of 0 or 1, or an improvement ≥ 2 over the baseline score, on ≥ 50% of days
16 weeks
Relief of IBS symptoms
Time Frame: 16 weeks
Adequate relief of IBS symptoms on ≥ 50% of the past weeks (a response of "yes" on ≥50% of the weeks to the following question: "Over the past week, have you had adequate relief of your IBS symptoms?)"
16 weeks
IBS-SSS score questionnaire (Severity Scoring System )
Time Frame: 16 weeks
To assess the severity of symptoms related to Irritable Bowel Syndrome, assessed at baseline and at the end of treatment after 12 weeks (it is considered clinically significant a score reduction of at least 50 points). The questionnaire is composed by five questions wich generate a maximum score of 100 each using prompted visual analogue scales, leading to a total possible score of 500.
16 weeks
Improvement in stool consistency
Time Frame: 16 weeks
stool consistency score ≤ 5 assessed with BSFS (Bristol Stool Form Scale) BSFS evaluates stool form and consistency (score from 1=dry stool to 7=liquid stoo. The ideal stool is generally 3 or 4)
16 weeks
Satisfaction with treatment
Time Frame: 16 weeks
Overall satisfaction with treatment assessed by VAS scale (Visual Analogue Scale)
16 weeks
Quality of life
Time Frame: 16 weeks
Quality of life assessment by validated Short-Form 12 Items Health Survey (SF-12) on a scale of 0 to 100
16 weeks
Intake of rescue medication
Time Frame: 16 weeks
type and frequencies of rescue medication
16 weeks
gut microbiota composition
Time Frame: 16 weeks
Evaluation of changes in the gut microbiota composition and the relative abundance of bacterial OTUs (Operational Taxonomic Unit).
16 weeks
Short Chain Fatty Acids (SCFA)
Time Frame: 16 weeks
Evaluation of Short Chain Fatty Acids levels in fecal samples
16 weeks
Free Aminoacids
Time Frame: 16 weeks
Evaluation of Free aminoacids levels in fecal samples
16 weeks
Biogenic Amines
Time Frame: 16 weeks
Evaluation of biogenic amines levels in fecal samples
16 weeks
Gut permeability for zonulin
Time Frame: 16 weeks
evaluation of serum levels of zonulin
16 weeks
Gut permeability for citrulline
Time Frame: 16 weeks
evaluation of serum levels of citrulline
16 weeks
Gut permeability for PV-1 (Plasmalemma vesicle-associated) protein
Time Frame: 16 weeks
evaluation of serum levels of PV-1 (Plasmalemma vesicle-associated) protein
16 weeks
L. casei DG® strain in the feces
Time Frame: 16 weeks
the recovery of L. casei DG® strain in the feces
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SOFAR S.p.A.

Collaborators

1Med

Investigators

  • Principal Investigator: Giovanni Barbara, MD, AUO Sant'Orsola Malpighi Bologna (Gastroenterology)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 6, 2017

Primary Completion (Actual)

May 4, 2021

Study Completion (Actual)

December 30, 2021

Study Registration Dates

First Submitted

February 7, 2018

First Submitted That Met QC Criteria

February 22, 2018

First Posted (Actual)

February 28, 2018

Study Record Updates

Last Update Posted (Actual)

May 6, 2022

Last Update Submitted That Met QC Criteria

May 5, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSC-DS PROBE2-IBS/17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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