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

NCT06423001 | Not Yet Recruiting DMC

• 1 other identifier: ID 2939
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

IBS - Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• 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).

  10 weeks

Secondary Outcomes (7)

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

  up to 4 weeks

• Adequate overall symptom relief after treatment,

  up to 10 days

• Change from baseline after treatment in NRS:

  up to 10 days

• Change from baseline after treatment in QqL:

  up to 10 days

• Change from baseline after treatment in HADS:

  up to 10 days

Study Arms (2)

PostbiotiX Slowing (Treatment A) Sequence AB

EXPERIMENTAL

Each patient will be supplied with the investigational product at Visit 0 (V0, Kit V0, PostibiotiX Slowing) and at visit 3 (V3, Kit V3, Placebo), based on the outcome of the randomization at V0 (Sequence AB, PostbiotiX Slowing/Placebo).

Dietary Supplement: PostbiotiX Slowing 4 g sachets PostbiotiX Slowing is a food supplement based on Fermented FOS from Lactobacillus paracasei CNCM I-5220.

Placebo (Tratment B) Sequence BA

EXPERIMENTAL

Each patient will be supplied with the investigational product at Visit 0 (V0, Kit V0, Placebo) and at visit 3 (V3, Kit V3, PostibiotiX Slowing), based on the outcome of the randomization at V0 (Sequence BA, Placebo/PostbiotiX Slowing).

Dietary Supplement: PostbiotiX Slowing 4 g sachets PostbiotiX Slowing is a food supplement based on Fermented FOS from Lactobacillus paracasei CNCM I-5220.

Interventions

PostbiotiX Slowing 4 g sachets PostbiotiX Slowing is a food supplement based on Fermented FOS from Lactobacillus paracasei CNCM I-5220. DIETARY_SUPPLEMENT

Each patient will be supplied with the investigational product at Visit 0, PostibiotiX Slowing and at visit 3, based on the outcome of the randomization at V0 (Sequence AB, PostbiotiX Slowing/Placebo; Sequence BA, Placebo/PostbiotiX Slowing).

Placebo (Tratment B) Sequence BA; PostbiotiX Slowing (Treatment A) Sequence AB

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

Study Sites (1)

Department of Gastroenterology, Humanitas Research Hospital

Rozzano, Milano, 20089, Italy

Location

Related Publications (10)

• 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.

  PMID: 33315591 BACKGROUND

• 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.

  PMID: 32702295 BACKGROUND

• 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.

  PMID: 14510740 BACKGROUND

• 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.

  PMID: 30522596 BACKGROUND

• 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.

  PMID: 33948025 BACKGROUND

• 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.

  PMID: 22301383 BACKGROUND

• Tsilingiri K, Rescigno M. Postbiotics: what else? Benef Microbes. 2013 Mar 1;4(1):101-7. doi: 10.3920/BM2012.0046.

  PMID: 23271068 BACKGROUND

• 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.

  PMID: 34556825 BACKGROUND

• Ma L, Tu H, Chen T. Postbiotics in Human Health: A Narrative Review. Nutrients. 2023 Jan 6;15(2):291. doi: 10.3390/nu15020291.

  PMID: 36678162 BACKGROUND

• 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.

  PMID: 20403231 BACKGROUND

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Central Study Contacts

Alessandro Repici, MD

CONTACT

0282247493; alessandro.repici@hunimed.eu

Vincenzo Craviotto, MD

CONTACT

0282243113; vincenzo.craviotto@humanitas.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2024
• First Posted: May 21, 2024
• Study Start: June 15, 2024
• Primary Completion: May 15, 2025
• Study Completion: May 15, 2026
• Last Updated: May 29, 2024

Record last verified: 2024-04

Locations

IT (1)