Efficacy and Safety of Oral Administration of Postibiotic by FOS Fermentation From Lactobacillus Paracasei in the Treatment of Irritable Bowel Syndrome.

N/ANot Yet RecruitingNCT06423001

Istituto Clinico Humanitas36 enrolled

Overview

Irritable bowel syndrome (IBS) is a highly prevalent functional pathology which currently has no real standardized and effective therapy, despite having a significant impact on quality of life and on social-health costs. Post-biotics have demonstrated in various in vitro and in vivo studies the ability to modulate the microbiota, the intestinal barrier function, the immune response as well as having systemic effects, with prospects for good efficacy in treatment of IBS.

PostbiotiX Slowing is a food supplement based on Fermented FOS from Lactobacillus paracasei CNCM I-5220, mallow and chamomile. The Fermented FOS from Lactobacillus paracasei CNCM I-5220 (postbiotic) is the result of a controlled fermentation. The fermentation process allows to eliminate all the individual variability that depends on the microbiota, the diet and the psycho-physical conditions of the single individual, offering a mixture of bacterial metabolites and fermented fiber (postbiotic), which has the functional activity. In addition, as FOS is already fermented it does not induce the formation of gas typical of fiber fermentation in IBS patients, thus providing all the beneficial effects of the fiber without its side effects. The fermented FOS from Lactobacillus paracasei CNCM I-5220 (postbiotic) is easily absorbed by the gut. Dosage and method of use: PostbiotiX Slowing 4 g sachets, administered at the dosage of one sachet a day. To pour the contents of the sachet in a glass, add 150 ml of water, mix until complete dissolution of the powder and taken immediately, preferably as soon as awakened, and away from meals. Ingredients: Maltodextrin, Aroma, Fermented FOS from Lactobacillus paracasei CNCM I-5220, mallow (Malva sylvestris L.) flowers and leaves d.e. tit. 20% polysaccharides, chamomile (Matricaria chamomilla L.) flowers d.e. tit. 0.3% apigenin, acidity regulator: citric acid; anti-caking agent: silicon dioxide; sweetener: sucralose. Conservation method: to be kept in a cool and dry place, away from light, humidity, and direct sources of heat.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 18-75 years * IBS diagnosis according to ROME IV criteria * Mild-moderate disease defined by IBS-SSS questionnaire at the baseline visit and after the washout period * Signed Informed Consent * Patients' ability to comply with the study procedures * Stable diet within two months prior to the screening visit * Negative colonoscopy (only \> 50 years old patients) Exclusion Criteria: * Therapy with drugs or supplements included in the prohibited list * Malignancy or history of malignancy, except patients with a history of surgically removed extraintestinal malignancy and a 5-year disease-free interval * Unstable psychiatric pathology * Organic bowel disease * Major abdominal surgery, except appendectomy and cholecystectomy * Relevant organic, systemic, metabolic pathologies or significant laboratory test abnormalities * Pregnant or nursing women * Patients with known hypersensitivity to one or more components of the product

Outcomes

Primary Outcomes

Reduction in symptom intensity

Evaluated using a symptom measurement scale, at each visit, on a 4-point Likert scale (IBS symptom scale; 4 symptoms for a minimum sum score of 0, maximum 12).

Time frame: 10 weeks

Secondary Outcomes

Change from baseline in IBS-SSS (symptom severity score)

IBS-SSS is a five-item questionnaire measuring frequency and intensity of abdominal pain, the severity of abdominal distension, dissatisfaction with bowel habits, and the interference of IBS with daily life, scoring from 0 to 500.

Time frame: up to 4 weeks

Adequate overall symptom relief after treatment,

To assess adequate overall relief, patients will be asked weekly to answer the question "Compared to how you usually felt before taking the treatment, how would you rate your symptom relief (abdominal pain, bowel habits, and other symptoms of IBS) in the past 10 days?" Possible answers: 1, very relieved; 2, relieved; 3, somewhat relieved; 4, unchanged; 5, slightly worsened; 6, worsened; 7, much worsened.

Time frame: up to 10 days

Change from baseline after treatment in NRS:

Severity score of each of the individual symptoms included in the IBS-SSS (VAS sub-scores), assessed by numeric rating scale (NRS) from 0 to 100

Time frame: up to 10 days

Change from baseline after treatment in QqL:

Quality of life as assessed by IBS-QoL: The individual responses to the 34 items are summed and averaged for a total score and then transformed to a 0-100 scale for ease of interpretation with higher scores indicating better IBS specific quality of life

Time frame: up to 10 days

Change from baseline after treatment in HADS:

Hospital anxiety and depression scale (HADS): HADS is a fourteen-item scale with seven items each for anxiety and depression subscales. Scoring for each item ranges from zero to three. A subscale score \>8 denotes anxiety or depression.

Time frame: up to 10 days

Fecal metagenomics:

Additional functional parameters in stool analysis differences before and after treatment (for example: digestive residues, bile acids, proteic composition)

Time frame: up to 10 days

Analyses of metabolomic:

Differences before and after treatment in the Sieric/plasma molecules such as for example Zonulin, soluble CD14, plasmatic inflammatory cytokines, bacterial DNA in the blood, and PBMCs analysis

Time frame: up to 10 days

Efficacy and Safety of Oral Administration of Postibiotic by FOS Fermentation From Lactobacillus Paracasei in the Treatment of Irritable Bowel Syndrome.

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts