Study To Evaluate The Efficacy of a Proprietary Mix of Live Probiotics In The Prophylaxis Of Diarrhea In Adult Patients
NCT ID: NCT06283784
Last Updated: 2024-03-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2021-09-05
2022-05-18
Brief Summary
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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)
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Detailed Description
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In the present trial, adult population already under antibiotic therapy with ampicillin/amoxicillin, cephalosporins and clindamycin, will be selected, in order to capture the highest possible diarrhea events, with a limited number of subjects.
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.
Placebo is an oral formulation of inert capsules. Placebo and YOVIS are identical in shape, size, colour and taste.
One-hundred (100) subjects will be randomized to receive either YOVIS or placebo (1:1) over a period of 10 days.
In case all inclusion/exclusion criteria are met, the subject will be randomized at the baseline visit to one of two masked trial treatments. Further phone contacts are scheduled on day 10±2 and day 21±2, a final visit at site is scheduled on day 28±2.
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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Investigational food supplement products will be packed in an individual way for each subject included in the investigation.
Study Groups
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Yovis Capsules
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.
Yovis Capsules
Subjects will assume the active treatment for 10 consecutive days (1 capsule once daily) with a drop of water, preferably without food.
Placebo
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.
Placebo
Subjects will assume the placebo treatment for 10 consecutive days (1 capsule once daily) with a drop of water, preferably without food.
Interventions
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Yovis Capsules
Subjects will assume the active treatment for 10 consecutive days (1 capsule once daily) with a drop of water, preferably without food.
Placebo
Subjects will assume the placebo treatment for 10 consecutive days (1 capsule once daily) with a drop of water, preferably without food.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subjects of both sexes between 18 and 65 years of age (limits included), with no limitation of race.
3. Patients being prescribed or having started an antibiotic therapy with ampicillin/amoxicillin, cephalosporins and clindamycin in the 48h preceding the screening.
4. Antibiotic therapy prescription with a lasting of at least 3 days but no more than 14 days.
5. 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.
1. Written informed consent, personally signed and dated by the subject.
2. Subjects of both sexes between 18 and 65 years of age (limits included), with no limitation of race.
3. Patients being prescribed or having started an antibiotic therapy with ampicillin/amoxicillin, cephalosporins and clindamycin in the 48h preceding the screening.
4. Antibiotic therapy prescription with a lasting of at least 3 days but no more than 14 days.
5. 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.
Exclusion Criteria
1. Pregnant or breast-feeding woman.
2. Known hypersensitivity or allergy to the active ingredients and/or to any component of the probiotic mix.
3. Subject with known food intolerance (eg. milk protein, gluten..)
4. Subject who has taken during the 2 weeks prior to inclusion, who is currently taking or plans to take other orally administered food supplements except the study product
5. Use of antidiarrhoeic drug is forbidden (maintenance of stable and regular treatment started more than 2 weeks before screening visit is allowed)
6. Active diarrhea at the time of the screening visit
7. Non controlled intestinal disease
8. Any antibiotic therapy in the 30 days preceding enrolment
9. Active participation in another clinical study
10. Subject with one or more psychiatric disturbances, such as: alcoholism, substance abuse or dependency disorder, bipolar disorder, schizophrenia, or other personality disorder.
18 Years
65 Years
ALL
No
Sponsors
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Hippocrates Research
OTHER
Biofarma
INDUSTRY
Responsible Party
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Principal Investigators
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Riccardo Agati, MD
Role: PRINCIPAL_INVESTIGATOR
General Practitioner
Locations
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General Practitioner Ambulatory
Sanremo, Italy/Imperia, Italy
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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YOVIS Capsules
Identifier Type: -
Identifier Source: org_study_id
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