Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| 1Med | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| L. casei DG® | Experimental | Interventions: Lactobacillus paracasei CNCMI1572 (At least 24 billion live cells per capsule) 1 capsule, b.i.d. for 12 weeks |
|
| Placebo | Placebo Comparator | Interventions : capsules for oral use, indistinguishable from active product. 1 capsule, b.i.d. for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| L.casei DG | Dietary Supplement | (At least 24 billion live cells per capsule) 1 capsule, b.i.d. for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of Pain relief | reduction of ≥ 30% from baseline in the score for the worst abdominal pain on ≥ 50% of days | 16 weeks |
| Evaluation of global symptom score | Improvement in the global symptom score: a score of 0 or 1, or an improvement ≥ 2 over the baseline score, on ≥ 50% of days |
Not provided
Inclusion Criteria:
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:
Negative relevant additional screening or consultation whenever appropriate
Ability to conform to the study protocol.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Giovanni Barbara, MD | AUO Sant'Orsola Malpighi Bologna (Gastroenterology) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| A.O. Bolognini | Seriate | BG | Italy | |||
| A.O. "G. Brotzu"- Ospedale San Michele |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27144627 | Background | 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. | |
| 27144620 | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| PLACEBO | Dietary Supplement | 1 capsule, b.i.d. for 12 weeks |
|
| 16 weeks |
| Relief of IBS symptoms | Adequate relief of IBS symptoms on ≥ 50% of the past weeks (a response of "yes" on ≥50% of the weeks to the following question: "Over the past week, have you had adequate relief of your IBS symptoms?)" | 16 weeks |
| IBS-SSS score questionnaire (Severity Scoring System ) | To assess the severity of symptoms related to Irritable Bowel Syndrome, assessed at baseline and at the end of treatment after 12 weeks (it is considered clinically significant a score reduction of at least 50 points). The questionnaire is composed by five questions wich generate a maximum score of 100 each using prompted visual analogue scales, leading to a total possible score of 500. | 16 weeks |
| Improvement in stool consistency | stool consistency score ≤ 5 assessed with BSFS (Bristol Stool Form Scale) BSFS evaluates stool form and consistency (score from 1=dry stool to 7=liquid stoo. The ideal stool is generally 3 or 4) | 16 weeks |
| Satisfaction with treatment | Overall satisfaction with treatment assessed by VAS scale (Visual Analogue Scale) | 16 weeks |
| Quality of life | Quality of life assessment by validated Short-Form 12 Items Health Survey (SF-12) on a scale of 0 to 100 | 16 weeks |
| Intake of rescue medication | type and frequencies of rescue medication | 16 weeks |
| gut microbiota composition | Evaluation of changes in the gut microbiota composition and the relative abundance of bacterial OTUs (Operational Taxonomic Unit). | 16 weeks |
| Short Chain Fatty Acids (SCFA) | Evaluation of Short Chain Fatty Acids levels in fecal samples | 16 weeks |
| Free Aminoacids | Evaluation of Free aminoacids levels in fecal samples | 16 weeks |
| Biogenic Amines | Evaluation of biogenic amines levels in fecal samples | 16 weeks |
| Gut permeability for zonulin | evaluation of serum levels of zonulin | 16 weeks |
| Gut permeability for citrulline | evaluation of serum levels of citrulline | 16 weeks |
| Gut permeability for PV-1 (Plasmalemma vesicle-associated) protein | evaluation of serum levels of PV-1 (Plasmalemma vesicle-associated) protein | 16 weeks |
| L. casei DG® strain in the feces | the recovery of L. casei DG® strain in the feces | 16 weeks |
| 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 | 40100 | Italy |
| Ospedale SS. Annunziata | Chieti | Italy |
| Fondazione IRCCS Policlinico | Milan | Italy |
| Policlinico | Naples | 80100 | Italy |
| Policlinico Federico II | Naples | Italy |
| Azienda Ospedaliera di Padova | Padova | Italy |
| Fondazione IRCCS Policlinico S. Matteo | Pavia | Italy |
| U.O. Gastroenterologia Universitaria | Pisa | Italy |
| Policlinico Universitario Campus Biomedico | Roma | 00128 | Italy |
| A.O. San Camillo-Forlanini | Roma | Italy |
| Ospedale Sant'Andrea | Roma | Italy |
| 19457422 | 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. |
| 18694443 | 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. |
| 19174795 | 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. |
| 25970536 | 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. |
| 21820992 | 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. |
| 24310267 | 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. |
| 22730468 | 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. |
| 19091823 | 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. |
| D004066 | Digestive System Diseases |