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

NCT03449628 | Completed

• 1 other identifier: PSC-DS PROBE2-IBS/17
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 20

Brief 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

Outcome Measures

Primary Outcomes (2)

• Proportion of patients who have a response in pain

  Patients who record on ≥ 50% of the days a reduction of ≥ 30% from their average baseline score for their worst abdominal pain.The standard 11-point numeric rating scale (from 0=none to 10=worst possible pain) will be used to measure abdominal pain.

  12 weeks

• Proportion of patients who have a response in stool consistencies

  Patients who record a stool-consistency score \< 5 in the same days in which they record a reduction of ≥ 30% from their average baseline score for their worst abdominal pain .For abnormal defecation, stool frequency and form will be measured using the Bristol Stool Form Scale (BSFS).

  12 weeks

Secondary Outcomes (16)

• Evaluation of Pain relief

  16 weeks

• Evaluation of global symptom score

  16 weeks

• Relief of IBS symptoms

  16 weeks

• IBS-SSS score questionnaire (Severity Scoring System )

  16 weeks

• Improvement in stool consistency

  16 weeks

Study Arms (2)

L. casei DG®

EXPERIMENTAL

Interventions: Lactobacillus paracasei CNCMI1572 (At least 24 billion live cells per capsule) 1 capsule, b.i.d. for 12 weeks

Dietary Supplement: L.casei DG

Placebo

PLACEBO COMPARATOR

Interventions : capsules for oral use, indistinguishable from active product. 1 capsule, b.i.d. for 12 weeks

Dietary Supplement: PLACEBO

Interventions

L.casei DG DIETARY_SUPPLEMENT

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

L. casei DG®

PLACEBO DIETARY_SUPPLEMENT

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

Placebo

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 non constipated IBS (i.e., IBS-D and IBS-M, both males and females), according to Rome IV criteria.
• A negative outcome of colonoscopy performed within 5 years before screening if patient is at least 50 years old, or if patient meet any of the following alarm features:
• Has a documented weight loss within the past 6 months; or
• Has nocturnal symptoms; or
• Has a familiar history of colon cancer; or
• Has blood mixed with their stool (excluding blood from hemorroids).
• Negative relevant additional screening or consultation whenever appropriate
• Ability to conform to the study protocol.

You may not qualify if:

• Patients with IBS-C or IBS-U according to Rome IV 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, (i.e..liver or kidney functional levels 2-times greater than the upper reference values)
• Ascertained intestinal organic diseases, including celiac disease, food allergies or inflammatory bowel diseases (Crohn's disease, ulcerative colitis, diverticular disease, infectious colitis, ischemic colitis, microscopic colitis).
• Previous major abdominal surgery.
• 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.
• Use of probiotics or topical and/or systemic antibiotic therapy during the last month.
• Systematic/frequent use of contact laxatives.
• Pregnant females or females of childbearing potential in the absence of effective contraceptive methods.
• Inability to conform to protocol.
• Treatment with any investigational drug within the previous 30 days.
• Recent history or suspicion of alcohol abuse or drug addiction.
• Presence of red or white flags at the Rome IV Psychosocial Alarm Questionnaire for Functional gastrointestinal Disorders.

Sponsors & Collaborators

• SOFAR S.p.A.: lead
• 1Med: collaborator

Study Sites (20)

A.O. Bolognini

Seriate, BG, Italy

Location

A.O. "G. Brotzu"- Ospedale San Michele

Cagliari, CA, Italy

Location

AOU di Cagliari - Policlinico di Monserrato

Cagliari, CA, Italy

Location

Ospedale Valduce

Como, CO, Italy

Location

ASST-FTB-Sacco

Milan, MI, Italy

Location

Policlinico San Donato

San Donato Milanese, MI, Italy

Location

Ospedale Sant'Andrea

Vercelli, VC, Italy

Location

Gastroenterologia Universitaria Policlinico Giovanni XXIII

Bari, Italy

Location

Azienda ULSS 1

Belluno, Italy

Location

Azienda Ospedaliero-Universitaria S. Orsola Malpighi

Bologna, 40100, Italy

Location

Ospedale SS. Annunziata

Chieti, Italy

Location

Fondazione IRCCS Policlinico

Milan, Italy

Location

Policlinico

Napoli, 80100, Italy

Location

Policlinico Federico II

Napoli, Italy

Location

Azienda Ospedaliera di Padova

Padua, Italy

Location

Fondazione IRCCS Policlinico S. Matteo

Pavia, Italy

Location

U.O. Gastroenterologia Universitaria

Pisa, Italy

Location

Policlinico Universitario Campus Biomedico

Roma, 00128, Italy

Location

A.O. San Camillo-Forlanini

Roma, Italy

Location

Ospedale Sant'Andrea

Roma, Italy

Location

Related Publications (10)

• Mearin F, Lacy BE, Chang L, Chey WD, Lembo AJ, Simren M, Spiller R. Bowel Disorders. Gastroenterology. 2016 Feb 18:S0016-5085(16)00222-5. doi: 10.1053/j.gastro.2016.02.031. Online ahead of print.

  PMID: 27144627 BACKGROUND

• Barbara G, Feinle-Bisset C, Ghoshal UC, Quigley EM, Santos J, Vanner S, Vergnolle N, Zoetendal EG. The Intestinal Microenvironment and Functional Gastrointestinal Disorders. Gastroenterology. 2016 Feb 18:S0016-5085(16)00219-5. doi: 10.1053/j.gastro.2016.02.028. Online ahead of print.

  PMID: 27144620 BACKGROUND

• Spiller R, Garsed K. Postinfectious irritable bowel syndrome. Gastroenterology. 2009 May;136(6):1979-88. doi: 10.1053/j.gastro.2009.02.074. Epub 2009 May 7.

  PMID: 19457422 BACKGROUND

• Schoepfer AM, Schaffer T, Seibold-Schmid B, Muller S, Seibold F. Antibodies to flagellin indicate reactivity to bacterial antigens in IBS patients. Neurogastroenterol Motil. 2008 Oct;20(10):1110-8. doi: 10.1111/j.1365-2982.2008.01166.x. Epub 2008 Aug 6.

  PMID: 18694443 BACKGROUND

• 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.

  PMID: 19174795 BACKGROUND

• Pimentel M, Morales W, Rezaie A, Marsh E, Lembo A, Mirocha J, Leffler DA, Marsh Z, Weitsman S, Chua KS, Barlow GM, Bortey E, Forbes W, Yu A, Chang C. Development and validation of a biomarker for diarrhea-predominant irritable bowel syndrome in human subjects. PLoS One. 2015 May 13;10(5):e0126438. doi: 10.1371/journal.pone.0126438. eCollection 2015.

  PMID: 25970536 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

• Jalanka-Tuovinen J, Salojarvi J, Salonen A, Immonen O, Garsed K, Kelly FM, Zaitoun A, Palva A, Spiller RC, de Vos WM. Faecal microbiota composition and host-microbe cross-talk following gastroenteritis and in postinfectious irritable bowel syndrome. Gut. 2014 Nov;63(11):1737-45. doi: 10.1136/gutjnl-2013-305994. Epub 2013 Dec 5.

  PMID: 24310267 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

• 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

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

• Giovanni Barbara, MD

  AUO Sant'Orsola Malpighi Bologna (Gastroenterology)

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 7, 2018
• First Posted: February 28, 2018
• Study Start: November 6, 2017
• Primary Completion: May 4, 2021
• Study Completion: December 30, 2021
• Last Updated: May 6, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (20)