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

Irritable Bowel Syndrome Clinical Trial

Official title:

Effect of Lactobacillus Casei dg (Enterolactis Plus®) in Patient With Irritable Bowel Syndrome: Multicenter, Randomized, Double-blind, Cross-over, Placebo Controlled, Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02371499
• Other study ID #: PROBE-IBS/14
• Status: Completed
• Phase: N/A
• First received: February 11, 2015
• Last updated: February 1, 2016
• Start date: December 2014
• Est. completion date: November 2015

Study information

• Verified date: February 2016
• Source: SOFAR S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Description:

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. The investigators suppose that, due to the immunomodulatory action of probiotics, overall abdominal pain/discomfort and symptoms will improve, fecal Immunoglobulin A levels will change, pro-inflammatory cytokine levels will decrease and the production of regulatory cytokines as Interleukin 10 will improve following consumption of Lactobacillus casei DG (Enterolactis plus®).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion 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.

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

Dietary Supplement:
• Lactobacillus casei DG
the patients will receive 1 capsule of Lactobacillus casei DG (Enterolactis plus®) twice daily for 4 weeks
• Placebo
the patients will receive 1 capsule of product without bacteria (Enterolactis placebo) twice daily for 4 weeks

Locations

Country	Name	City	State
Italy	Azienda ULSS 1	Belluno
Italy	Azienda Ospedaliero-Universitaria S. Orsola Malpighi	Bologna
Italy	U.O. Gastroenterologia Universitaria	Pisa
Italy	Policlinico Universitario Campus Biomedico	Roma
Italy	Policlinico S.Donato	San Donato	Milano

Sponsors (1)

Lead Sponsor	Collaborator
SOFAR S.p.A.

Country where clinical trial is conducted

Italy, 

References & Publications (11)

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Jeffery IB, O'Toole PW, Öhman L, Claesson MJ, Deane J, Quigley EM, Simrén 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. — View Citation

Longstreth GF, Thompson WG, Chey WD, Houghton LA, Mearin F, Spiller RC. Functional bowel disorders. Gastroenterology. 2006 Apr;130(5):1480-91. Review. Erratum in: Gastroenterology. 2006 Aug;131(2):688. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Simrén 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	Stool frequency and consistency as assessed by Bristol Scale		1 day	No
Primary	Microbiota of fecal sample as characterized by Ion Torrent Personal Genome Machine sequencing of 16S ribosomal RNA-based amplicons		4 weeks	No
Primary	Overall satisfaction with treatment as measured by Visual Analogue Scale		4 weeks	No
Primary	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	No
Primary	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	No
Primary	Consumption of rescue medication		1 day	No
Primary	Secretory Immunoglobulin A and cytokines levels in fecal samples as measured by ELISA test.		4 weeks	No