Diarrhea
Conditions
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)
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.
Interventions
OTHERYovis Capsules
Subjects will assume the active treatment for 10 consecutive days (1 capsule once daily) with a drop of water, preferably without food.
OTHERPlacebo
Subjects will assume the placebo treatment for 10 consecutive days (1 capsule once daily) with a drop of water, preferably without food.
Sponsors
Hippocrates Research
Biofarma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
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.
Intervention model description
This is a double blind, randomized, placebo-controlled study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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 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
Inclusion criteria Subjects will be included in the study if they meet all the following 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 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of YOVIS in preventing the incidence of AADD in subjects under antibiotic therapy | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of duration and severity of gastrointestinal symptoms | 28 days | number of patients with gastrointestinal symptoms in the two groups |
| Impact of bowel habits on QoL | 10-21-28 days | 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 |
| Effects of YOVIS, versus placebo, at each visit on the overall health status | 10-21-28 days | 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) |
| Severity and duration of AAD | Time Frame: 28 days | Cumulated duration of antibiotic-associated diarrhea (AAD) : number of days with diarrhea within the observation period |
| Global Patient's self-reported acceptance at the end of study | 28 days | 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 |
| Global acceptability (investigator) at the end of study | 28 days | 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 |
| Assessment of acceptability, safety and satisfaction grade of YOVIS versus placebo | 10 days | 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. |
Countries
Italy
Outcome results
None listed