Clinical trial NCT06423001: Efficacy and Safety of Oral Administration of Postibiotic by FOS Fermentation From Lactobacillus Paracasei in the Treatment of Irritable Bowel Syndrome.
Official title: A Randomized, Cross-over, Placebo-Controlled, Double-Blind Clinical Trial on the Efficacy and Safety of Oral Administration of Postibiotic by FOS Fermentation From Lactobacillus Paracasei in the Treatment of Irritable Bowel Syndrome.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: IBS - Irritable Bowel Syndrome
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2024-05-21
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Reduction in symptom intensity
timeFrame: 10 weeks
Secondary outcomes:
measure: Change from baseline in IBS-SSS (symptom severity score)
timeFrame: up to 4 weeks
measure: Adequate overall symptom relief after treatment,
timeFrame: up to 10 days
measure: Change from baseline after treatment in NRS:
timeFrame: up to 10 days
measure: Change from baseline after treatment in QqL:
timeFrame: up to 10 days
measure: Change from baseline after treatment in HADS:
timeFrame: up to 10 days
measure: Fecal metagenomics:
timeFrame: up to 10 days
measure: Analyses of metabolomic:
timeFrame: up to 10 days
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Department of Gastroenterology, Humanitas Research Hospital
state: Milano
Study officials:
References:
citation: Lacy BE, Pimentel M, Brenner DM, Chey WD, Keefer LA, Long MD, Moshiree B. ACG Clinical Guideline: Management of Irritable Bowel Syndrome. Am J Gastroenterol. 2021 Jan 1;116(1):17-44. doi: 10.14309/ajg.0000000000001036.
citation: Oka P, Parr H, Barberio B, Black CJ, Savarino EV, Ford AC. Global prevalence of irritable bowel syndrome according to Rome III or IV criteria: a systematic review and meta-analysis. Lancet Gastroenterol Hepatol. 2020 Oct;5(10):908-917. doi: 10.1016/S2468-1253(20)30217-X. Epub 2020 Jul 20.
citation: Inadomi JM, Fennerty MB, Bjorkman D. Systematic review: the economic impact of irritable bowel syndrome. Aliment Pharmacol Ther. 2003 Oct 1;18(7):671-82. doi: 10.1046/j.1365-2036.2003.t01-1-01736.x.
citation: Camilleri M. Management Options for Irritable Bowel Syndrome. Mayo Clin Proc. 2018 Dec;93(12):1858-1872. doi: 10.1016/j.mayocp.2018.04.032.
citation: Salminen S, Collado MC, Endo A, Hill C, Lebeer S, Quigley EMM, Sanders ME, Shamir R, Swann JR, Szajewska H, Vinderola G. The International Scientific Association of Probiotics and Prebiotics (ISAPP) consensus statement on the definition and scope of postbiotics. Nat Rev Gastroenterol Hepatol. 2021 Sep;18(9):649-667. doi: 10.1038/s41575-021-00440-6. Epub 2021 May 4.
citation: Tsilingiri K, Barbosa T, Penna G, Caprioli F, Sonzogni A, Viale G, Rescigno M. Probiotic and postbiotic activity in health and disease: comparison on a novel polarised ex-vivo organ culture model. Gut. 2012 Jul;61(7):1007-15. doi: 10.1136/gutjnl-2011-300971. Epub 2012 Feb 1.
citation: Tsilingiri K, Rescigno M. Postbiotics: what else? Benef Microbes. 2013 Mar 1;4(1):101-7. doi: 10.3920/BM2012.0046.
citation: Aguilar-Toala JE, Arioli S, Behare P, Belzer C, Berni Canani R, Chatel JM, D'Auria E, de Freitas MQ, Elinav E, Esmerino EA, Garcia HS, da Cruz AG, Gonzalez-Cordova AF, Guglielmetti S, de Toledo Guimaraes J, Hernandez-Mendoza A, Langella P, Liceaga AM, Magnani M, Martin R, Mohamad Lal MT, Mora D, Moradi M, Morelli L, Mosca F, Nazzaro F, Pimentel TC, Ran C, Ranadheera CS, Rescigno M, Salas A, Sant'Ana AS, Sivieri K, Sokol H, Taverniti V, Vallejo-Cordoba B, Zelenka J, Zhou Z. Postbiotics - when simplification fails to clarify. Nat Rev Gastroenterol Hepatol. 2021 Nov;18(11):825-826. doi: 10.1038/s41575-021-00521-6. No abstract available.
citation: Ma L, Tu H, Chen T. Postbiotics in Human Health: A Narrative Review. Nutrients. 2023 Jan 6;15(2):291. doi: 10.3390/nu15020291.
citation: Adams CA. The probiotic paradox: live and dead cells are biological response modifiers. Nutr Res Rev. 2010 Jun;23(1):37-46. doi: 10.1017/S0954422410000090. Epub 2010 Apr 20.