Effect of Lactobacillus Casei DG (Enterolactis Plus®) in Patient With Irritable Bowel Syndrome: a Pilot Study

NCT02371499 | Completed

• 1 other identifier: PROBE-IBS/14
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 5

Brief Summary

The aim of the study is to collect data for the assessment of the Lactobacillus casei DG (Enterolactis plus®) effect on overall abdominal pain/discomfort, symptoms and gut microbiota composition in patients with Irritable Bowel Syndrome.

Conditions

Irritable Bowel Syndrome

Keywords

Irritable Bowel Syndrome; Lactobacillus casei dg; microbiota

Outcome Measures

Primary Outcomes (9)

• Abdominal pain/discomfort as measured by 11-point Numerical Rating Scale

  evaluation performed using a daily 11-point Numerical Rating Scale scale from "0" (none) to "10" (very severe) - (responders are defined as patients with ≥ 30% reduction in the weekly mean abdominal pain and/or discomfort score, versus mean value of run-in period, in at least 2 weeks out of the 4 weeks of the treatment period)

  1 day

• Irritable Bowel Syndrome degree-of-relief as measured by 7-point balanced ordinal scale

  evaluation performed using weekly 7-point balanced ordinal scale, where "1"="completely relieved", "4"="unchanged" and "7"="as bad as I can imagine" - (responders are defined as patients reporting "completely relieved"=score 1 or "considerably relieved"=score 2 in at least 2 weeks out of the 4 weeks of the treatment period)

  1 week

• Stool frequency and consistency as assessed by Bristol Scale

  1 day

• Microbiota of fecal sample as characterized by Ion Torrent Personal Genome Machine sequencing of 16S ribosomal RNA-based amplicons

  4 weeks

• Overall satisfaction with treatment as measured by Visual Analogue Scale

  4 weeks

• Quality of life as measured by Short-Form 12 Items Health Survey

  evaluation performed using the validated Short-Form 12 Items Health Survey (SF-12) on a scale of 0 to 100

  4 weeks

• Anxiety and Depression as assessed by Hospital Anxiety and Depression Scale (HADS)

  evaluation performed using Hospital Anxiety and Depression Scale (HADS): seven items each for anxiety and depression, with a 4-point Likert scale (0-3) for each item providing a minimum score of 0 and a maximum score of 21 on each sub-scale

  4 weeks

• Consumption of rescue medication

  1 day

• Secretory Immunoglobulin A and cytokines levels in fecal samples as measured by ELISA test.

  4 weeks

Study Arms (2)

1st Arm

EXPERIMENTAL

Treatment with Lactobacillus casei DG (Enterolactis plus®)

Dietary Supplement: Lactobacillus casei DG

2nd Arm

PLACEBO COMPARATOR

Treatment with equivalent product without bacteria (Enterolactis placebo)

Dietary Supplement: Placebo

Interventions

Lactobacillus casei DG DIETARY_SUPPLEMENT

the patients will receive 1 capsule of Lactobacillus casei DG (Enterolactis plus®) twice daily for 4 weeks

Also known as: Enterolactis plus®

1st Arm

Placebo DIETARY_SUPPLEMENT

the patients will receive 1 capsule of product without bacteria (Enterolactis placebo) twice daily for 4 weeks

2nd Arm

Eligibility Criteria

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

You may qualify if:

• Age \> 18 years and ≤ 65 years.
• A positive diagnosis of Irritable Bowel Syndrome regardless of bowel habit (both males and females), according to Rome III criteria.
• Negative outcome of barium enema or left colonoscopy within the previous two years.
• Negative relevant additional screening or consultation whenever appropriate.
• Ability of conforming to the study protocol.

You may not qualify if:

• 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.
• Ascertained intestinal organic diseases, including ascertained celiac disease or inflammatory bowel diseases (Crohn's disease, ulcerative colitis, diverticular disease, infectious colitis, ischemic colitis, microscopic colitis).
• Previous major abdominal surgeries.
• 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.
• Assumption of probiotics or topic and/or systemic antibiotic therapy during the last month.
• Systematical/frequent assumption of contact laxatives.
• Females of childbearing potential, in the absence of effective contraceptive methods.
• Pregnant women.
• Inability to conform with protocol.
• Treatment with any investigational drug within the previous 30 days.
• Recent history or suspicion of alcohol abuse or drug addiction.
• Previous participation in this study.

Sponsors & Collaborators

• SOFAR S.p.A.: lead

Study Sites (5)

Policlinico S.Donato

San Donato, Milano, 20097, Italy

Location

U.O. Gastroenterologia Universitaria

Pisa, Pisa, Italy

Location

Azienda ULSS 1

Belluno, Italy

Location

Azienda Ospedaliero-Universitaria S. Orsola Malpighi

Bologna, 40100, Italy

Location

Policlinico Universitario Campus Biomedico

Roma, 00128, Italy

Location

Related Publications (12)

• Longstreth GF, Thompson WG, Chey WD, Houghton LA, Mearin F, Spiller RC. Functional bowel disorders. Gastroenterology. 2006 Apr;130(5):1480-91. doi: 10.1053/j.gastro.2005.11.061.

  PMID: 16678561 BACKGROUND

• Barbara G, Stanghellini V. Biomarkers in IBS: when will they replace symptoms for diagnosis and management? Gut. 2009 Dec;58(12):1571-5. doi: 10.1136/gut.2008.169672. No abstract available.

  PMID: 19923339 BACKGROUND

• Cremon C, Carini G, De Giorgio R, Stanghellini V, Corinaldesi R, Barbara G. Intestinal dysbiosis in irritable bowel syndrome: etiological factor or epiphenomenon? Expert Rev Mol Diagn. 2010 May;10(4):389-93. doi: 10.1586/erm.10.33.

  PMID: 20465494 BACKGROUND

• Simren M, Barbara G, Flint HJ, Spiegel BM, Spiller RC, Vanner S, Verdu EF, Whorwell PJ, Zoetendal EG; Rome Foundation Committee. Intestinal microbiota in functional bowel disorders: a Rome foundation report. Gut. 2013 Jan;62(1):159-76. doi: 10.1136/gutjnl-2012-302167. Epub 2012 Jun 22.

  PMID: 22730468 BACKGROUND

• Rajilic-Stojanovic M, Biagi E, Heilig HG, Kajander K, Kekkonen RA, Tims S, de Vos WM. Global and deep molecular analysis of microbiota signatures in fecal samples from patients with irritable bowel syndrome. Gastroenterology. 2011 Nov;141(5):1792-801. doi: 10.1053/j.gastro.2011.07.043. Epub 2011 Aug 5.

  PMID: 21820992 BACKGROUND

• Jeffery IB, O'Toole PW, Ohman L, Claesson MJ, Deane J, Quigley EM, Simren M. An irritable bowel syndrome subtype defined by species-specific alterations in faecal microbiota. Gut. 2012 Jul;61(7):997-1006. doi: 10.1136/gutjnl-2011-301501. Epub 2011 Dec 16.

  PMID: 22180058 BACKGROUND

• Moayyedi P, Ford AC, Talley NJ, Cremonini F, Foxx-Orenstein AE, Brandt LJ, Quigley EM. The efficacy of probiotics in the treatment of irritable bowel syndrome: a systematic review. Gut. 2010 Mar;59(3):325-32. doi: 10.1136/gut.2008.167270. Epub 2008 Dec 17.

  PMID: 19091823 BACKGROUND

• Madsen K, Cornish A, Soper P, McKaigney C, Jijon H, Yachimec C, Doyle J, Jewell L, De Simone C. Probiotic bacteria enhance murine and human intestinal epithelial barrier function. Gastroenterology. 2001 Sep;121(3):580-91. doi: 10.1053/gast.2001.27224.

  PMID: 11522742 BACKGROUND

• Eun CS, Kim YS, Han DS, Choi JH, Lee AR, Park YK. Lactobacillus casei prevents impaired barrier function in intestinal epithelial cells. APMIS. 2011 Jan;119(1):49-56. doi: 10.1111/j.1600-0463.2010.02691.x. Epub 2010 Oct 25.

  PMID: 21143526 BACKGROUND

• Corinaldesi R, Stanghellini V, Cremon C, Gargano L, Cogliandro RF, De Giorgio R, Bartesaghi G, Canovi B, Barbara G. Effect of mesalazine on mucosal immune biomarkers in irritable bowel syndrome: a randomized controlled proof-of-concept study. Aliment Pharmacol Ther. 2009 Aug;30(3):245-52. doi: 10.1111/j.1365-2036.2009.04041.x. Epub 2009 May 12.

  PMID: 19438846 BACKGROUND

• Quigley EM, Tack J, Chey WD, Rao SS, Fortea J, Falques M, Diaz C, Shiff SJ, Currie MG, Johnston JM. Randomised clinical trials: linaclotide phase 3 studies in IBS-C - a prespecified further analysis based on European Medicines Agency-specified endpoints. Aliment Pharmacol Ther. 2013 Jan;37(1):49-61. doi: 10.1111/apt.12123. Epub 2012 Nov 1.

  PMID: 23116208 BACKGROUND

• Cremon C, Guglielmetti S, Gargari G, Taverniti V, Castellazzi AM, Valsecchi C, Tagliacarne C, Fiore W, Bellini M, Bertani L, Gambaccini D, Cicala M, Germana B, Vecchi M, Pagano I, Barbaro MR, Bellacosa L, Stanghellini V, Barbara G. Effect of Lactobacillus paracasei CNCM I-1572 on symptoms, gut microbiota, short chain fatty acids, and immune activation in patients with irritable bowel syndrome: A pilot randomized clinical trial. United European Gastroenterol J. 2018 May;6(4):604-613. doi: 10.1177/2050640617736478. Epub 2017 Oct 8.

  PMID: 29881616 DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

• Giorvanni Barbara, MD

  Policlinico S. Orsola-Malpighi - Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2015
• First Posted: February 25, 2015
• Study Start: December 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: February 2, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (5)