DiarrheaNCT06283784
Study To Evaluate The Efficacy of a Proprietary Mix of Live Probiotics In The Prophylaxis Of Diarrhea In Adult Patients
A study testing Yovis Capsules in people with Diarrhea, run by Biofarma at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diarrhea
- What is being tested?
- Yovis Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 5 Sep 2021to 18 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Inclusion criteria Subjects will be included in the study if they meet all the following criteria.
- 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.
Show all 17Show fewer
- 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..)
- 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
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double Blind, Randomized, Placebo Controlled Study To Evaluate The Efficacy of a Proprietary Mix of Live Probiotics in the Prophylaxis Of Diarrhea In Adult Patients Who Already Initiated An Oral Antibiotic Therapy
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)
Read the detailed description
AAD is defined as clinically unexplained diarrhea that occurs in connection with antibiotic administration. Any antibiotic could potentially cause AAD, but broad-spectrum antibiotics that predominantly target anaerobes and are poorly absorbed, such as clindamycin, cephalosporins (cefixime and ceftriaxone), and amoxicillin-clavulanate, have a higher AAD incidence (Turck D, 2003). It has been reported that the highest rates of AAD in 650 pediatric cases were associated with amoxicillin/clavulanate (23%), penicillin A or M (11%) and erythromycin (16%).
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
- Diarrhea
- Being tested
- Yovis Capsules, Placebo
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yovis CapsulesOther
Also called Probiothic
Subjects will assume the active treatment for 10 consecutive days (1 capsule once daily) with a drop of water, preferably without food.
PlaceboOther
Subjects will assume the placebo treatment for 10 consecutive days (1 capsule once daily) with a drop of water, preferably without food.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 days - 21 days - 28 days
Secondary outcomes (10)
Severity and duration of AAD
Cumulated duration of antibiotic-associated diarrhea (AAD) : number of days with diarrhea within the observation period
Measured: Time Frame: 28 days
Severity and duration of AAD
Cumulative severity of antibiotic-associated diarrhea (AAD): sum of the values (obtained by transformation of Bristol stool form types) of all stools during days with diarrhea (transformation of Bristol scale types is defined: type 1 to 4 = 0; type 5 = 1; type 6 = 2 and type 7 = 3) diarrhea within the observation period
Measured: Time Frame: 28 days
Evaluation of duration and severity of gastrointestinal symptoms
number of patients with gastrointestinal symptoms in the two groups
Measured: 28 days
Evaluation of duration and severity of gastrointestinal symptoms
cumulative duration with symptoms in the two groups;
Measured: 28 days
Evaluation of duration and severity of gastrointestinal symptoms
the cumulative severity of each symptom
Measured: 28 days
Impact of bowel habits on QoL
assessed trough a 6-item questionnaire self-compiled by the subject at each visit. Quality of Life Questionnaire is compiled. 6 questions from minimum value of 0 (no impact) to 10 (maximum impact) on the quality of life
Measured: 10-21-28 days
Effects of YOVIS, versus placebo, at each visit on the overall health status
assessed trough questions on the general well-being and through physical examination during visits. Questionnaire on the Gatrointestinal syntoms. each question minimum value is 0 (no pain at all) to 10 (maximum intensity of pain)
Measured: 10-21-28 days
Assessment of acceptability, safety and satisfaction grade of YOVIS versus placebo
Patient satisfaction will be evaluated at the end of treatment. The clinician will ask the patient his satisfaction grade compared to her expectation, in a 5-point scale: Not at all Satisfied," "Partly Satisfied," "Satisfied," "More than Satisfied," "Very Satisfied," numbering 1 to 5 as an interval scale.
Measured: 10 days
Global Patient's self-reported acceptance at the end of study
Global patient's acceptance to the treatment will be evaluated at the end of study visit, referred to the whole period, as bad, good, fair, excellent
Measured: 28 days
Global acceptability (investigator) at the end of study
Global investigator acceptance to the treatment will be evaluated at the end of study visit, referred to the whole period, as bad, good, fair, excellent
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start5 Sep 2021
- Primary completion2 Nov 2021
- Study completion18 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for DiarrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a double blind, randomized, placebo-controlled study.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biofarma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hippocrates Research
- Responsible party
- Sponsor
- Investigators
- Riccardo Agati, MD, Principal investigator, General Practitioner
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06283784
- Sponsor's protocol ID
- YOVIS Capsules
- Status last verified
- Mar 2024
- First submitted
- 22 Feb 2024
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24499072Arvola 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.
PubMed 10545590Beaugerie 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.
PubMed 15123074Chu 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.
PubMed 20955192Collado 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.
PubMed 15848292Cotter PD, Hill C, Ross RP. Bacteriocins: developing innate immunity for food. Nat Rev Microbiol. 2005 Oct;3(10):777-88. doi: 10.1038/nrmicro1273.
PubMed 16205711Hempel 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.
PubMed 22570464Hill 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.
PubMed 24912386Lee 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.
PubMed 12972590Lewis 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.
PubMed 9299672Lui 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.
PubMed 29273046Lukasik 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.
PubMed 32469907Ritchie 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.
PubMed 22529959Servin 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.
PubMed 15374659Turck 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.
PubMed 12827001
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind, Randomized, Placebo Controlled Study To Evaluate The Efficacy of a Proprietary Mix of Live Probiotics in the Prophylaxis Of Diarrhea In Adult Patients Who Already Initiated An Oral Antibiotic Therapy
- ClinicalTrials.gov ID
- NCT06283784
- Acronym / sponsor ID
- YOVIS Capsules
- Conditions
- Diarrhea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- BiofarmaIndustry (pharma, biotech, devices)
- Collaborators
- Hippocrates Research
- Study start
- 5 Sep 2021 (actual)
- Primary completion
- 2 Nov 2021 (actual)
- Study completion
- 18 May 2022 (actual)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed description
AAD is defined as clinically unexplained diarrhea that occurs in connection with antibiotic administration. Any antibiotic could potentially cause AAD, but broad-spectrum antibiotics that predominantly target anaerobes and are poorly absorbed, such as clindamycin, cephalosporins (cefixime and ceftriaxone), and amoxicillin-clavulanate, have a higher AAD incidence (Turck D, 2003). It has been reported that the highest rates of AAD in 650 pediatric cases were associated with amoxicillin/clavulanate (23%), penicillin A or M (11%) and erythromycin (16%).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This is a double blind, randomized, placebo-controlled study.
| Arm | Type | Receives |
|---|---|---|
| Yovis Capsules | Experimental | Other: Yovis CapsulesYOVIS, 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. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (17 listed)
- Inclusion criteria Subjects will be included in the study if they meet all the following criteria.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yovis CapsulesAlso: ProbiothicSubjects will assume the active treatment for 10 consecutive days (1 capsule once daily) with a drop of water, preferably without food. | Other | Yovis Capsules |
| PlaceboSubjects will assume the placebo treatment for 10 consecutive days (1 capsule once daily) with a drop of water, preferably without food. | Other | Placebo |
Primary outcome
Efficacy of YOVIS in preventing the incidence of AADD in subjects under antibiotic therapy
Time frame: 10 days - 21 days - 28 days
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 secondary outcomes
Severity and duration of AAD
Time frame: Time Frame: 28 days
Severity and duration of AAD
Time frame: Time Frame: 28 days
Evaluation of duration and severity of gastrointestinal symptoms
Time frame: 28 days
Evaluation of duration and severity of gastrointestinal symptoms
Time frame: 28 days
Evaluation of duration and severity of gastrointestinal symptoms
Time frame: 28 days
Impact of bowel habits on QoL
Time frame: 10-21-28 days
Effects of YOVIS, versus placebo, at each visit on the overall health status
Time frame: 10-21-28 days
Assessment of acceptability, safety and satisfaction grade of YOVIS versus placebo
Time frame: 10 days
Global Patient's self-reported acceptance at the end of study
Time frame: 28 days
Global acceptability (investigator) at the end of study
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Results publication: PubMed 24499072Ashraf 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.
- Results publication: PubMed 10545590Arvola 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.
- Results publication: PubMed 15123074Beaugerie 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.
- Results publication: PubMed 20955192Chu 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.
- Results publication: PubMed 15848292Collado 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.
- Results publication: PubMed 16205711Cotter PD, Hill C, Ross RP. Bacteriocins: developing innate immunity for food. Nat Rev Microbiol. 2005 Oct;3(10):777-88. doi: 10.1038/nrmicro1273.
- Results publication: PubMed 22570464Hempel 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.
- Results publication: PubMed 24912386Hill 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.
- Results publication: PubMed 12972590Lee 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.
- Results publication: PubMed 9299672Lewis 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.
- Results publication: PubMed 29273046Lui 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.
- Results publication: PubMed 32469907Lukasik 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Riccardo Agati, MD principal investigator
General Practitioner
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yovis Capsules in people with Diarrhea, run by Biofarma at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of YOVIS in preventing the incidence of AADD in subjects under antibiotic therapy (time frame: 10 days - 21 days - 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06283784, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2024; AzTrials last refreshed its copy on 6 Nov 2026.