Study To Evaluate The Efficacy of a Proprietary Mix of Live Probiotics In The Prophylaxis Of Diarrhea In Adult Patients

NCT06283784 | Completed

• 1 other identifier: YOVIS Capsules
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This is a double blind, randomized, placebo-controlled study. One-hundred subjects are randomized to receive either YOVIS or placebo over a period of 10 days. The purpose is to determinate the efficacy of the treatment in subjects treated with antibiotic therapy, by measuring occurrence of Antibiotic Associated Diarrhoea (AAD) from baseline to the end of the observation period (28±2 days)

Conditions

Diarrhea

Outcome Measures

Primary Outcomes (1)

• Efficacy of YOVIS in preventing the incidence of AADD in subjects under antibiotic therapy

  The primary objective of this study is to assess, versus placebo, the efficacy of a 10 days treatment with YOVIS in preventing the incidence of AAD in subjects under antibiotic therapy. The incidence of diarrhea in the treatment group will be compared to placebo in the time frame of 28 days.

  10 days - 21 days - 28 days

Secondary Outcomes (10)

• Severity and duration of AAD

  Time Frame: 28 days

• Severity and duration of AAD

  Time Frame: 28 days

• Evaluation of duration and severity of gastrointestinal symptoms

  28 days

• Evaluation of duration and severity of gastrointestinal symptoms

  28 days

• Evaluation of duration and severity of gastrointestinal symptoms

  28 days

Study Arms (2)

Yovis Capsules

EXPERIMENTAL

YOVIS, the Investigational Food Supplement (IFS), is an oral formulation (capsules) containing definite mix of live probiotics already marketed by Alfa-Sigma as food supplement since September 2017. it is administered to 50 patients 10 consecutive days (1 capsule once daily) with a drop of water, preferably without food.

Other: Yovis Capsules

Placebo

PLACEBO COMPARATOR

Placebo is an oral formulation of inert capsules. it is administered to 50 patients 10 consecutive days (1 capsule once daily) with a drop of water, preferably without food.

Other: Placebo

Interventions

Yovis Capsules OTHER

Subjects will assume the active treatment for 10 consecutive days (1 capsule once daily) with a drop of water, preferably without food.

Also known as: Probiothic

Yovis Capsules

Placebo OTHER

Subjects will assume the placebo treatment for 10 consecutive days (1 capsule once daily) with a drop of water, preferably without food.

Placebo

Eligibility Criteria

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

You may qualify if:

• Written informed consent, personally signed and dated by the subject.
• Subjects of both sexes between 18 and 65 years of age (limits included), with no limitation of race.
• Patients being prescribed or having started an antibiotic therapy with ampicillin/amoxicillin, cephalosporins and clindamycin in the 48h preceding the screening.
• Antibiotic therapy prescription with a lasting of at least 3 days but no more than 14 days.
• Subject able to comprehend the full nature and purpose of the study, available to cooperate with the Investigator and to comply with the requirements of the entire study.

You may not qualify if:

• Written informed consent, personally signed and dated by the subject.
• Subjects of both sexes between 18 and 65 years of age (limits included), with no limitation of race.
• Patients being prescribed or having started an antibiotic therapy with ampicillin/amoxicillin, cephalosporins and clindamycin in the 48h preceding the screening.
• Antibiotic therapy prescription with a lasting of at least 3 days but no more than 14 days.
• Subject able to comprehend the full nature and purpose of the study, available to cooperate with the Investigator and to comply with the requirements of the entire study.
• Subjects will be excluded if they meet any of the following criteria:
• Pregnant or breast-feeding woman.
• Known hypersensitivity or allergy to the active ingredients and/or to any component of the probiotic mix.
• Subject with known food intolerance (eg. milk protein, gluten..)
• Use of antidiarrhoeic drug is forbidden (maintenance of stable and regular treatment started more than 2 weeks before screening visit is allowed)
• Active diarrhea at the time of the screening visit
• Non controlled intestinal disease
• Any antibiotic therapy in the 30 days preceding enrolment
• Active participation in another clinical study
• Subject with one or more psychiatric disturbances, such as: alcoholism, substance abuse or dependency disorder, bipolar disorder, schizophrenia, or other personality disorder.

Sponsors & Collaborators

• Biofarma: lead
• Hippocrates Research: collaborator

Study Sites (1)

General Practitioner Ambulatory

Sanremo, Italy/Imperia, 18038, Italy

Location

Related Publications (16)

• Ashraf R, Shah NP. Immune system stimulation by probiotic microorganisms. Crit Rev Food Sci Nutr. 2014;54(7):938-56. doi: 10.1080/10408398.2011.619671.

  PMID: 24499072 RESULT

• Arvola T, Laiho K, Torkkeli S, Mykkanen H, Salminen S, Maunula L, Isolauri E. Prophylactic Lactobacillus GG reduces antibiotic-associated diarrhea in children with respiratory infections: a randomized study. Pediatrics. 1999 Nov;104(5):e64. doi: 10.1542/peds.104.5.e64.

  PMID: 10545590 RESULT

• Beaugerie L, Petit JC. Microbial-gut interactions in health and disease. Antibiotic-associated diarrhoea. Best Pract Res Clin Gastroenterol. 2004 Apr;18(2):337-52. doi: 10.1016/j.bpg.2003.10.002.

  PMID: 15123074 RESULT

• Chu W, Lu F, Zhu W, Kang C. Isolation and characterization of new potential probiotic bacteria based on quorum-sensing system. J Appl Microbiol. 2011 Jan;110(1):202-8. doi: 10.1111/j.1365-2672.2010.04872.x. Epub 2010 Oct 18.

  PMID: 20955192 RESULT

• Collado MC, Gonzalez A, Gonzalez R, Hernandez M, Ferrus MA, Sanz Y. Antimicrobial peptides are among the antagonistic metabolites produced by Bifidobacterium against Helicobacter pylori. Int J Antimicrob Agents. 2005 May;25(5):385-91. doi: 10.1016/j.ijantimicag.2005.01.017.

  PMID: 15848292 RESULT

• Cotter PD, Hill C, Ross RP. Bacteriocins: developing innate immunity for food. Nat Rev Microbiol. 2005 Oct;3(10):777-88. doi: 10.1038/nrmicro1273.

  PMID: 16205711 RESULT

• Hempel S, Newberry SJ, Maher AR, Wang Z, Miles JN, Shanman R, Johnsen B, Shekelle PG. Probiotics for the prevention and treatment of antibiotic-associated diarrhea: a systematic review and meta-analysis. JAMA. 2012 May 9;307(18):1959-69. doi: 10.1001/jama.2012.3507.

  PMID: 22570464 RESULT

• Hill C, Guarner F, Reid G, Gibson GR, Merenstein DJ, Pot B, Morelli L, Canani RB, Flint HJ, Salminen S, Calder PC, Sanders ME. Expert consensus document. The International Scientific Association for Probiotics and Prebiotics consensus statement on the scope and appropriate use of the term probiotic. Nat Rev Gastroenterol Hepatol. 2014 Aug;11(8):506-14. doi: 10.1038/nrgastro.2014.66. Epub 2014 Jun 10.

  PMID: 24912386 RESULT

• Lee YK, Puong KY, Ouwehand AC, Salminen S. Displacement of bacterial pathogens from mucus and Caco-2 cell surface by lactobacilli. J Med Microbiol. 2003 Oct;52(Pt 10):925-930. doi: 10.1099/jmm.0.05009-0.

  PMID: 12972590 RESULT

• Lewis SJ, Heaton KW. Stool form scale as a useful guide to intestinal transit time. Scand J Gastroenterol. 1997 Sep;32(9):920-4. doi: 10.3109/00365529709011203.

  PMID: 9299672 RESULT

• Lui M, Gallo-Hershberg D, DeAngelis C. Development and validation of a patient-reported questionnaire assessing systemic therapy induced diarrhea in oncology patients. Health Qual Life Outcomes. 2017 Dec 22;15(1):249. doi: 10.1186/s12955-017-0794-6.

  PMID: 29273046 RESULT

• Lukasik J, Guo Q, Boulos L, Szajewska H, Johnston BC. Probiotics for the prevention of antibiotic-associated adverse events in children-A scoping review to inform development of a core outcome set. PLoS One. 2020 May 29;15(5):e0228824. doi: 10.1371/journal.pone.0228824. eCollection 2020.

  PMID: 32469907 RESULT

• Ritchie ML, Romanuk TN. A meta-analysis of probiotic efficacy for gastrointestinal diseases. PLoS One. 2012;7(4):e34938. doi: 10.1371/journal.pone.0034938. Epub 2012 Apr 18.

  PMID: 22529959 RESULT

• Servin AL. Antagonistic activities of lactobacilli and bifidobacteria against microbial pathogens. FEMS Microbiol Rev. 2004 Oct;28(4):405-40. doi: 10.1016/j.femsre.2004.01.003.

  PMID: 15374659 RESULT

• Turck D, Bernet JP, Marx J, Kempf H, Giard P, Walbaum O, Lacombe A, Rembert F, Toursel F, Bernasconi P, Gottrand F, McFarland LV, Bloch K. Incidence and risk factors of oral antibiotic-associated diarrhea in an outpatient pediatric population. J Pediatr Gastroenterol Nutr. 2003 Jul;37(1):22-6. doi: 10.1097/00005176-200307000-00004.

  PMID: 12827001 RESULT

• von Ossowski I, Reunanen J, Satokari R, Vesterlund S, Kankainen M, Huhtinen H, Tynkkynen S, Salminen S, de Vos WM, Palva A. Mucosal adhesion properties of the probiotic Lactobacillus rhamnosus GG SpaCBA and SpaFED pilin subunits. Appl Environ Microbiol. 2010 Apr;76(7):2049-57. doi: 10.1128/AEM.01958-09. Epub 2010 Jan 29.

  PMID: 20118368 RESULT

MeSH Terms

Conditions

Diarrhea

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Riccardo Agati, MD

  General Practitioner

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: YOVIS, the Investigational Food Supplement (IFS), is an oral formulation (capsules) containing definite mix of live probiotics. Placebo is an oral formulation of inert capsules. Placebo and YOVIS are identical in shape, size, colour and taste. Product test and placebo capsules will be indistinguishable. Investigational food supplement products will be packed in an individual way for each subject included in the investigation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a double blind, randomized, placebo-controlled study.

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: February 28, 2024
• Study Start: September 5, 2021
• Primary Completion: November 2, 2021
• Study Completion: May 18, 2022
• Last Updated: March 18, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)