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

Not Applicable

Completed

• Conditions: IBS - Irritable Bowel Syndrome
• Interventions: Dietary Supplement: PLACEBO; Dietary Supplement: L.casei DG

• Registration Number: NCT03449628
• Lead Sponsor: SOFAR S.p.A.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-06
• Study First Submitted: 2018-02-07
• Study First Submitted QC: 2018-02-22
• Study First Posted: 2018-02-28
• Primary Completion: 2021-05-04
• Study Completion: 2021-12-30
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-05
• Last Update Posted: 2022-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 264

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:

  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

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	PLACEBO	Interventions : capsules for oral use, indistinguishable from active product. 1 capsule, b.i.d. for 12 weeks
L. casei DG®	L.casei DG	Interventions: Lactobacillus paracasei CNCMI1572 (At least 24 billion live cells per capsule) 1 capsule, b.i.d. for 12 weeks

Primary Outcome Measures

Name	Time	Method
Proportion of patients who have a response in pain	12 weeks	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.
Proportion of patients who have a response in stool consistencies	12 weeks	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).

Secondary Outcome Measures

Name	Time	Method
Evaluation of Pain relief	16 weeks	reduction of ≥ 30% from baseline in the score for the worst abdominal pain on ≥ 50% of days
Evaluation of global symptom score	16 weeks	Improvement in the global symptom score: a score of 0 or 1, or an improvement ≥ 2 over the baseline score, on ≥ 50% of days
Relief of IBS symptoms	16 weeks	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?)"
IBS-SSS score questionnaire (Severity Scoring System )	16 weeks	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.
Improvement in stool consistency	16 weeks	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)
Satisfaction with treatment	16 weeks	Overall satisfaction with treatment assessed by VAS scale (Visual Analogue Scale)
Quality of life	16 weeks	Quality of life assessment by validated Short-Form 12 Items Health Survey (SF-12) on a scale of 0 to 100
Intake of rescue medication	16 weeks	type and frequencies of rescue medication
gut microbiota composition	16 weeks	Evaluation of changes in the gut microbiota composition and the relative abundance of bacterial OTUs (Operational Taxonomic Unit).
Short Chain Fatty Acids (SCFA)	16 weeks	Evaluation of Short Chain Fatty Acids levels in fecal samples
Free Aminoacids	16 weeks	Evaluation of Free aminoacids levels in fecal samples
Biogenic Amines	16 weeks	Evaluation of biogenic amines levels in fecal samples
Gut permeability for zonulin	16 weeks	evaluation of serum levels of zonulin
Gut permeability for citrulline	16 weeks	evaluation of serum levels of citrulline
Gut permeability for PV-1 (Plasmalemma vesicle-associated) protein	16 weeks	evaluation of serum levels of PV-1 (Plasmalemma vesicle-associated) protein
L. casei DG® strain in the feces	16 weeks	the recovery of L. casei DG® strain in the feces

Trial Locations

Locations (19)

AOU di Cagliari - Policlinico di Monserrato; 🇮🇹 Cagliari, CA, Italy

Policlinico Federico II; 🇮🇹 Napoli, Italy

Azienda Ospedaliera di Padova; 🇮🇹 Padova, Italy

Ospedale Valduce; 🇮🇹 Como, CO, Italy

ASST-FTB-Sacco; 🇮🇹 Milano, MI, Italy

Ospedale SS. Annunziata; 🇮🇹 Chieti, Italy

Ospedale Sant'Andrea; 🇮🇹 Roma, Italy

A.O. Bolognini; 🇮🇹 Seriate, BG, Italy

A.O. "G. Brotzu"- Ospedale San Michele; 🇮🇹 Cagliari, CA, Italy

Policlinico San Donato; 🇮🇹 San Donato Milanese, MI, Italy

Fondazione IRCCS Policlinico; 🇮🇹 Milano, Italy

Azienda Ospedaliero-Universitaria S. Orsola Malpighi; 🇮🇹 Bologna, Italy

Gastroenterologia Universitaria Policlinico Giovanni XXIII; 🇮🇹 Bari, Italy

Azienda ULSS 1; 🇮🇹 Belluno, Italy

Policlinico Universitario Campus Biomedico; 🇮🇹 Roma, Italy

Policlinico; 🇮🇹 Napoli, Italy

U.O. Gastroenterologia Universitaria; 🇮🇹 Pisa, Italy

A.O. San Camillo-Forlanini; 🇮🇹 Roma, Italy

Fondazione IRCCS Policlinico S. Matteo; 🇮🇹 Pavia, Italy