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

Last updated: March 15, 2024
Sponsor: Biofarma
Overall Status: Completed

Phase

N/A

Condition

Stomach Discomfort

Lactose Intolerance

Bowel Dysfunction

Treatment

Yovis Capsules

Placebo

Clinical Study ID

NCT06283784
YOVIS Capsules
  • Ages 18-65
  • All Genders

Study 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)

Eligibility Criteria

Inclusion

Inclusion Criteria:

  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 nolimitation of race.
  3. Patients being prescribed or having started an antibiotic therapy withampicillin/amoxicillin, cephalosporins and clindamycin in the 48h preceding thescreening.
  4. Antibiotic therapy prescription with a lasting of at least 3 days but no more than 14days.
  5. Subject able to comprehend the full nature and purpose of the study, available tocooperate with the Investigator and to comply with the requirements of the entirestudy.

Exclusion

Exclusion Criteria: Inclusion criteria Subjects will be included in the study if they meet all the followingcriteria.

  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 nolimitation of race.
  3. Patients being prescribed or having started an antibiotic therapy withampicillin/amoxicillin, cephalosporins and clindamycin in the 48h preceding thescreening.
  4. Antibiotic therapy prescription with a lasting of at least 3 days but no more than 14days.
  5. Subject able to comprehend the full nature and purpose of the study, available tocooperate with the Investigator and to comply with the requirements of the entirestudy. Exclusion Criteria Subjects will be excluded if they meet any of the following criteria:
  6. Pregnant or breast-feeding woman.
  7. Known hypersensitivity or allergy to the active ingredients and/or to any component ofthe probiotic mix.
  8. Subject with known food intolerance (eg. milk protein, gluten..)
  9. Subject who has taken during the 2 weeks prior to inclusion, who is currently takingor plans to take other orally administered food supplements except the study product
  10. Use of antidiarrhoeic drug is forbidden (maintenance of stable and regular treatmentstarted more than 2 weeks before screening visit is allowed)
  11. Active diarrhea at the time of the screening visit
  12. Non controlled intestinal disease
  13. Any antibiotic therapy in the 30 days preceding enrolment
  14. Active participation in another clinical study
  15. Subject with one or more psychiatric disturbances, such as: alcoholism, substanceabuse or dependency disorder, bipolar disorder, schizophrenia, or other personalitydisorder.

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Yovis Capsules
Phase:
Study Start date:
September 05, 2021
Estimated Completion Date:
May 18, 2022

Study 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.

Connect with a study center

  • General Practitioner Ambulatory

    Sanremo, Italy/Imperia 18038
    Italy

    Site Not Available

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