L. Casei DG® in Patients With Irritable Bowel Syndrome.
NCT ID: NCT03449628
Last Updated: 2022-05-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
264 participants
INTERVENTIONAL
2017-11-06
2021-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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L. casei DG®
Interventions: Lactobacillus paracasei CNCMI1572 (At least 24 billion live cells per capsule)
1 capsule, b.i.d. for 12 weeks
L.casei DG
(At least 24 billion live cells per capsule)
1 capsule, b.i.d. for 12 weeks
Placebo
Interventions : capsules for oral use, indistinguishable from active product.
1 capsule, b.i.d. for 12 weeks
PLACEBO
1 capsule, b.i.d. for 12 weeks
Interventions
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L.casei DG
(At least 24 billion live cells per capsule)
1 capsule, b.i.d. for 12 weeks
PLACEBO
1 capsule, b.i.d. for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* 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:
1. Has a documented weight loss within the past 6 months; or
2. Has nocturnal symptoms; or
3. Has a familiar history of colon cancer; or
4. 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.
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, (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.
18 Years
65 Years
ALL
No
Sponsors
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1Med
OTHER
SOFAR S.p.A.
INDUSTRY
Responsible Party
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Principal Investigators
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Giovanni Barbara, MD
Role: PRINCIPAL_INVESTIGATOR
AUO Sant'Orsola Malpighi Bologna (Gastroenterology)
Locations
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A.O. Bolognini
Seriate, BG, Italy
A.O. "G. Brotzu"- Ospedale San Michele
Cagliari, CA, Italy
AOU di Cagliari - Policlinico di Monserrato
Cagliari, CA, Italy
Ospedale Valduce
Como, CO, Italy
ASST-FTB-Sacco
Milan, MI, Italy
Policlinico San Donato
San Donato Milanese, MI, Italy
Ospedale Sant'Andrea
Vercelli, VC, Italy
Gastroenterologia Universitaria Policlinico Giovanni XXIII
Bari, , Italy
Azienda ULSS 1
Belluno, , Italy
Azienda Ospedaliero-Universitaria S. Orsola Malpighi
Bologna, , Italy
Ospedale SS. Annunziata
Chieti, , Italy
Fondazione IRCCS Policlinico
Milan, , Italy
Policlinico
Napoli, , Italy
Policlinico Federico II
Napoli, , Italy
Azienda Ospedaliera di Padova
Padua, , Italy
Fondazione IRCCS Policlinico S. Matteo
Pavia, , Italy
U.O. Gastroenterologia Universitaria
Pisa, , Italy
Policlinico Universitario Campus Biomedico
Roma, , Italy
A.O. San Camillo-Forlanini
Roma, , Italy
Ospedale Sant'Andrea
Roma, , Italy
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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PSC-DS PROBE2-IBS/17
Identifier Type: -
Identifier Source: org_study_id
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