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Completed

NCT Number: NCT02077699

Efficacy Evaluation of a Commercial Preparation Containing Lactobacillus Casei DG on the Reduction of the Painful Symptoms Related to the Irritable Bowel Syndrome (IBS). A Pilot Clinical Study

The purpose of this study is to evaluate the efficacy of a treatment with Lactobacillus casei DG in the reduction of the painful symptoms in patients affected by irritable bowel syndrome. After that, the secondary object is to evaluate if the reduction of painful symptoms is related to a relevant reduction of trypsin and tryptase in colonic mucosa.

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UOC di Gastroenterologia - Policlinico Tor Vergata

Roma, 00133, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • out-Patients with diagnosis of Irritable Bowel syndrome (IBS) according to Rome III Diagnostic Criteria for Functional Gastrointestinal Disorders
  • Previous colonoscopy (within 24 month prior the enrollment) with negative results
  • written informed consent

Exclusion criteria

  • systemic or topical therapy with steroids and glucocorticoids such as beclomethasone dipropionate or budesonide, ongoing or within a month prior the enrollment
  • therapy with antibiotics or probiotics, ongoing or within a month prior the enrollment
  • inflammatory bowel diseases
  • copro-paraxitological examination with positive results
  • bowel disease with infectious, actinic, endocrine or drug-related origin
  • immunodeficiency
  • diagnosis of malignant cancer within 5 years prior the enrollment
  • renal, hepatic, hematologic, cardiovascular, pulmonary, neurological, psychiatric, immunological, gastrointestinal or endocrine disorders, if found to be clinically relevant
  • any severe disease that may interfere with the treatment;
  • abuse of alcohol, drugs or medication, psychotropic drugs
  • diagnosis of dementia or other disorders that can cause a progressive deterioration of capacity of discernment or mental and physical disability which reduces the ability to follow the prescribed therapy;
  • previous participation in this study
  • pregnant or nursing (lactating) women

Treatment and study plan

Lactobacillus casei DG

Dietary Supplement

Lactobacillus casei DG (24 billion of live cells per pill) - 2 pills b.i.d. for 4 weeks

Other names: Enterolactis plus

Primary outcomes

  1. Intensity of painful symptoms

    Time frame: 4 weeks

    The efficacy of the treatment will be evaluated recording the intensity of the painful symptoms associated with irritable bowel syndrome for the duration of the study. The intensity of abdominal pain will be recorded daily by the patient in a diary using a semi-quantitative scale (Likert) to 6 points, from 0 (absent) to 5 (very severe).

Secondary outcomes

  1. Level of trypsin and tryptase in colonic mucosa

    Time frame: 4 weeks

    Will evaluate the reduction in the levels of trypsin and tryptase in the colonic mucosa by collecting biopsies from the sigmoid colon and samples colonic lavage fluid and subsequent histological and molecular examination with extraction of m-RNA and proteins.

Sponsors and collaborators

Lead sponsor

SOFAR S.p.A.

Industry

Registry information

Official study title

Valutazione Dell'Efficacia Di Una Preparazione Commerciale A Base Di Lactobacillus Casei Dg Nella Riduzione Della Sintomatologia Dolorosa Associata Alla Sindrome Dell' Intestino Irritabile (Sii). Studio Clinico Pilota. (Official Title in Italian Language)

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Mar 4, 2014
Registry last updated
Dec 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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