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L. Casei DG® in Patients With Irritable Bowel Syndrome.

NCT03449628 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 264

Last updated 2022-05-06

No results posted yet for this study

Summary

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.

Conditions

  • IBS - Irritable Bowel Syndrome

Interventions

DIETARY_SUPPLEMENT

L.casei DG

(At least 24 billion live cells per capsule) 1 capsule, b.i.d. for 12 weeks

DIETARY_SUPPLEMENT

PLACEBO

1 capsule, b.i.d. for 12 weeks

Sponsors & Collaborators

  • 1Med

    collaborator OTHER

  • SOFAR S.p.A.

    lead INDUSTRY

Principal Investigators

  • Giovanni Barbara, MD · AUO Sant'Orsola Malpighi Bologna (Gastroenterology)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-06
Primary Completion
2021-05-04
Completion
2021-12-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03449628 on ClinicalTrials.gov