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Irritable Bowel SyndromePhase 4NCT02077699

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

A Phase 4 study testing Lactobacillus casei DG in people with Irritable Bowel Syndrome, run by SOFAR S.p.A. at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Irritable Bowel Syndrome
What is being tested?
Lactobacillus casei DG
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteItaly
Study dates
Mar 2012to Jun 2014
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • UOC di Gastroenterologia - Policlinico Tor Vergata

    Roma, Roma, 00133

Other trials in Italy

About this study

Official 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)

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.

Being tested
Lactobacillus casei DG
Keywords
Lactobacillus casei DG, Irritable Bowel Syndrome
Medical subject headings
Irritable Bowel Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lactobacillus casei DGDietary supplement

    Also called Enterolactis plus

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

Study groups in NCT02077699
Study groupRoleWhat they receive
1ExperimentalTreatment with Lactobacillus casei DG (24 billion of live cells per pill) 2 pills b.i.d. for 4 weeks
Receives: Dietary Supplement: Lactobacillus casei DG

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Intensity of painful symptoms

    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).

    Measured: 4 weeks

Secondary outcomes (1)

  1. Level of trypsin and tryptase in colonic mucosa

    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.

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2014 (estimated)
  2. Study startMar 2012
  3. Primary completionJun 2014
  4. Study completionJun 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02077699
Sponsor's protocol ID
IBS-DG 10
Status last verified
Nov 2014
First submitted
28 Feb 2014
Last updated
2 Dec 2014
Results posted
No
Data monitoring committee
No

Publications

  • Hungin AP, Chang L, Locke GR, Dennis EH, Barghout V. Irritable bowel syndrome in the United States: prevalence, symptom patterns and impact. Aliment Pharmacol Ther. 2005 Jun 1;21(11):1365-75. doi: 10.1111/j.1365-2036.2005.02463.x.

    PubMed 15932367

  • Thompson WG, Longstreth GF, Drossman DA, Heaton KW, Irvine EJ, Muller-Lissner SA. Functional bowel disorders and functional abdominal pain. Gut. 1999 Sep;45 Suppl 2(Suppl 2):II43-7. doi: 10.1136/gut.45.2008.ii43.

    PubMed 10457044

  • Langhorst J, Junge A, Rueffer A, Wehkamp J, Foell D, Michalsen A, Musial F, Dobos GJ. Elevated human beta-defensin-2 levels indicate an activation of the innate immune system in patients with irritable bowel syndrome. Am J Gastroenterol. 2009 Feb;104(2):404-10. doi: 10.1038/ajg.2008.86. Epub 2009 Jan 20.

    PubMed 19174795

  • Salzmann JL, Peltier-Koch F, Bloch F, Petite JP, Camilleri JP. Morphometric study of colonic biopsies: a new method of estimating inflammatory diseases. Lab Invest. 1989 Jun;60(6):847-51.

    PubMed 2733385

  • O'Sullivan M, Clayton N, Breslin NP, Harman I, Bountra C, McLaren A, O'Morain CA. Increased mast cells in the irritable bowel syndrome. Neurogastroenterol Motil. 2000 Oct;12(5):449-57. doi: 10.1046/j.1365-2982.2000.00221.x.

    PubMed 11012945

  • Barbara G, Stanghellini V, De Giorgio R, Cremon C, Cottrell GS, Santini D, Pasquinelli G, Morselli-Labate AM, Grady EF, Bunnett NW, Collins SM, Corinaldesi R. Activated mast cells in proximity to colonic nerves correlate with abdominal pain in irritable bowel syndrome. Gastroenterology. 2004 Mar;126(3):693-702. doi: 10.1053/j.gastro.2003.11.055.

    PubMed 14988823

  • Gwee KA, Collins SM, Read NW, Rajnakova A, Deng Y, Graham JC, McKendrick MW, Moochhala SM. Increased rectal mucosal expression of interleukin 1beta in recently acquired post-infectious irritable bowel syndrome. Gut. 2003 Apr;52(4):523-6. doi: 10.1136/gut.52.4.523.

    PubMed 12631663

  • Fahlgren A, Hammarstrom S, Danielsson A, Hammarstrom ML. beta-Defensin-3 and -4 in intestinal epithelial cells display increased mRNA expression in ulcerative colitis. Clin Exp Immunol. 2004 Aug;137(2):379-85. doi: 10.1111/j.1365-2249.2004.02543.x.

    PubMed 15270856

  • O'Mahony L, McCarthy J, Kelly P, Hurley G, Luo F, Chen K, O'Sullivan GC, Kiely B, Collins JK, Shanahan F, Quigley EM. Lactobacillus and bifidobacterium in irritable bowel syndrome: symptom responses and relationship to cytokine profiles. Gastroenterology. 2005 Mar;128(3):541-51. doi: 10.1053/j.gastro.2004.11.050.

    PubMed 15765388

  • Rembacken BJ, Snelling AM, Hawkey PM, Chalmers DM, Axon AT. Non-pathogenic Escherichia coli versus mesalazine for the treatment of ulcerative colitis: a randomised trial. Lancet. 1999 Aug 21;354(9179):635-9. doi: 10.1016/s0140-6736(98)06343-0.

    PubMed 10466665

  • Venturi A, Gionchetti P, Rizzello F, Johansson R, Zucconi E, Brigidi P, Matteuzzi D, Campieri M. Impact on the composition of the faecal flora by a new probiotic preparation: preliminary data on maintenance treatment of patients with ulcerative colitis. Aliment Pharmacol Ther. 1999 Aug;13(8):1103-8. doi: 10.1046/j.1365-2036.1999.00560.x.

    PubMed 10468688

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Lactobacillus casei DG in people with Irritable Bowel Syndrome, run by SOFAR S.p.A. at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intensity of painful symptoms (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02077699, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2014.

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