An interventional study of Brevicillin® gocce (Bifidobacterium breve PRL2020) and Placebo (matching oil drops) in Antibiotic-associated Diarrhea, sponsored by Liaquat University of Medical & Health Sciences. Not yet recruiting at 20 sites in Italy. Open to participants aged 0 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-11-13.
Sponsored by Liaquat University of Medical & Health Sciences · Not applicable, Interventional, and Prevention
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Among 26 studies in Diarrhea with a site in Italy — 4 open to participants now, 4 under way, none of them phase 3. Diarrhea · Italy.
Among the 26 studies in Diarrhea with a site in Italy, this one is the 2nd largest by planned enrollment of the 22 interventional ones that give a count, is the only one that started in 2026, is one of 15 with no phase, and was the 26th registered.
878 studies on the registry are indexed under Diarrhea; 77 are open to participants now.
Browse Diarrhea studies →4 of the 26 studies in Diarrhea with a site in Italy are open now. Recruiting first, the newest first:
ABResearch S.r.l. · Sites in Italy
Ages 18+
Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Sites in Italy
Ages 3 mo–24 mo
University of Padova · Sites in Italy
Ages 18–80
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 45 Diarrhea studies recruiting now, 21 (47%) set no upper age limit and 22 (49%) stop at 75 or younger; 19 take children under 18; 15 take healthy volunteers.
This study: 0 Years to 12 Years · all sexes · no healthy volunteers.
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26 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 3 · Phase 3 3 · Phase 4 2
First in 2006; this study’s year is marked. 1 started in 2026.
This study's planned enrollment of 1,024 is above the median of 138 across 739 interventional studies indexed under Diarrhea.
Median enrollment 117 across the 22 interventional studies, 71 across the 4 observational. Of the 19 that completed or were terminated, 2 (11%) have results posted.
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10 of 26 have an industry lead sponsor. The 10 most frequent:
Liaquat University of Medical & Health Sciences is the lead sponsor of 57 studies on the registry; 19 are open to participants now.
Liaquat University of Medical & Health Sciences has 3 studies filed under Diarrhea — fewer than ten, so there is no comparison to draw.
1 of the studies in Diarrhea with a site in Italy that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07936656Liaquat University of Medical & Health SciencesProbiotic Bifidobacterium Breve PRL2020 in Oral Drops in Preventing Side Effects From Amoxicillin or Amoxicillin/Clavulanic Acid Antibiotic Use | 2027-03-01 |
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Among the 26 studies in Diarrhea with a site in Italy, from their registry updates:
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This multicenter, randomized, double-blind, placebo-controlled clinical trial will evaluate the efficacy and safety of the probiotic Bifidobacterium breve PRL2020 (Brevicillin® gocce) in preventing gastrointestinal side effects associated with antibiotic therapy using amoxicillin or amoxicillin/clavulanic acid in pediatric patients aged 0-12 years. Participants will be randomized 1:1 to receive either the probiotic supplement or placebo during standard antibiotic treatment for 6-10 days, followed by a post-treatment observation period up to day 15 without probiotic or placebo administration. The primary objective is to assess the reduction in the incidence of antibiotic-associated diarrhea (AAD).
Antibiotic therapy with amoxicillin or amoxicillin/clavulanic acid is widely prescribed in pediatric populations but is frequently associated with gastrointestinal adverse effects, particularly diarrhea. These effects are linked to disruption of the gut microbiota and a reduction in bifidobacterial populations. Bifidobacterium breve PRL2020 is a probiotic strain with demonstrated intrinsic, non-transferable resistance to these antibiotics and has been developed to mitigate antibiotic-induced dysbiosis.
This study is a multicenter, prospective, randomized, double-blind, placebo-controlled, non-profit trial conducted in pediatric centers across Italy. The study aims to evaluate the clinical efficacy and safety of Bifidobacterium breve PRL2020 in reducing the incidence and severity of antibiotic-associated diarrhea (AAD) in children receiving amoxicillin or amoxicillin/clavulanic acid.
A total of 1024 participants will be enrolled. Participants will be randomized 1:1 to receive either Brevicillin® gocce (5 drops 2-3 times daily, containing 5 billion CFU of B. breve PRL2020 per dose) or matching placebo only during antibiotic therapy (6-10 days). After completion of antibiotic treatment, participants will enter a follow-up period until day 15 without probiotic or placebo administration.
The primary outcome is the incidence of AAD, defined as ≥3 diarrheal episodes in one day during antibiotic treatment (Bristol Stool Scale 5-7).
Secondary outcomes include the incidence and duration of diarrhea, daily bowel movements, stool consistency, gastrointestinal and extra-intestinal symptoms (such as nausea, vomiting, abdominal pain), treatment compliance, and adverse events.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive Brevicillin® gocce, a probiotic food supplement containing Bifidobacterium breve PRL2020 (LMG S-32458), alongside standard antibiotic therapy with amoxicillin or amoxicillin/clavulanic acid. Dosage and administration: 5 drops, 2-3 times per day (depending on antibiotic dosing schedule), administered during the antibiotic treatment period (6-10 days). After completion of antibiotic therapy, participants will enter a follow-up period until day 15 without probiotic administration.
Dietary Supplement: Brevicillin® gocce (Bifidobacterium breve PRL2020)
Participants will receive a placebo formulation matched in appearance, packaging, and dosing schedule to Brevicillin® gocce, administered alongside standard antibiotic therapy with amoxicillin or amoxicillin/clavulanic acid. The placebo will be given at the same frequency (5 drops, 2-3 times per day) and duration as the experimental product during the antibiotic treatment period (6-10 days). After antibiotic completion, participants will enter a follow-up period until day 15 without placebo administration.
Other: Placebo (matching oil drops)
Brevicillin® gocce is a probiotic dietary supplement in oily drops containing the bacterial strain Bifidobacterium breve PRL2020 (LMG S-32458). Each 5-drop dose contains approximately 5 billion live cells. The supplement is administered orally 2-3 times per day, in parallel with antibiotic therapy (amoxicillin or amoxicillin/clavulanic acid), for 6-10 days only (during the antibiotic course). After completion of antibiotic therapy, participants enter a follow-up period until day 15 without probiotic administration. The product is manufactured by PharmExtracta S.p.A., Pontenure, Italy.
The placebo is a formulation identical in appearance, packaging, and administration schedule to Brevicillin® gocce but without the Bifidobacterium breve PRL2020 strain. It is administered orally 2-3 times per day only during the antibiotic treatment period (6-10 days). After antibiotic completion, participants enter a follow-up period until day 15 without placebo administration.
Incidence of Antibiotic-Associated Diarrhea (AAD)
Evaluation of the efficacy of Bifidobacterium breve PRL2020 (Brevicillin® gocce) in reducing the incidence of antibiotic-associated diarrhea (AAD), defined as ≥3 diarrheal episodes within one day of antibiotic treatment, with stool consistency corresponding to types 5-7 on the Bristol Stool Scale. Data will be collected through a daily diary completed by the parent or legal guardian.
Time frame: 15 days
Incidence of children with at least one episode of diarrhea
Number of participants experiencing at least one episode of diarrhea during the study period, as recorded in the daily diary.
Time frame: 15 days
Number of daily defecations
Average number of daily bowel movements recorded by the parent or guardian during the study period, using the child's daily diary.
Time frame: 15 days
Number of days with diarrhea
Total number of days in which diarrhea occurs during the observation period, recorded by the parent or guardian.
Time frame: 15 days
Stool consistency
Assessment of stool consistency using the Bristol Stool Scale (BSS) to evaluate changes in bowel habits during and after antibiotic treatment.
Time frame: 15 days
Abdominal pain During and After Antibiotic Treatment
Assessment of abdominal pain related to antibiotic use, as recorded in daily diary entries completed by the parent or guardian.
Time frame: 15 days
Nausea During and After Antibiotic Treatment
Assessment of nausea related to antibiotic use, as recorded in daily diary entries completed by the parent or guardian.
Time frame: 15 days
Vomiting During and After Antibiotic Treatment
Assessment of vomiting related to antibiotic use, as recorded in daily diary entries completed by the parent or guardian.
Time frame: 15 days
Treatment compliance
Assessment of adherence to the probiotic or placebo regimen, graded by the pediatrician on a scale from "poor" to "excellent" at the end of the study period.
Time frame: 15 days
Adverse events
Documentation and evaluation of any adverse events reported during treatment and follow-up, as recorded in the child's daily diary and verified by the study physician.
Time frame: 15 days
Start is estimated for Nov 2026; primary completion for Mar 2027, 3 months later.
Of 129 non-industry interventional studies with no phase under Diarrhea, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 36. This study's planned 3 months is below that.
Counting every sponsor, half of 164 studies reached it within 14 months; a quarter within 5 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Liaquat University of Medical & Health Sciences