Bio-Kult Infantis® in AAD Prevention in Infants
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|ClinicalTrials.gov Identifier: NCT03516409|
Recruitment Status : Recruiting
First Posted : May 4, 2018
Last Update Posted : September 12, 2018
Background: antibiotic-associated diarrhoea (AAD) is defined as an acute inflammation of the intestinal mucosa associated to the administration of antibiotics. Its aetiology seems to be linked to the impact of antibiotics on the normal digestive microbiota. Acute otitis media (AOM) is a common paediatric condition and it is one of the most commonly cited indication for antimicrobial therapy in children (amoxicillin + clavulanic acid).
Treatment modalities for AAD are limited because no established treatment exists for non-Clostridium difficile associated AAD, except for discontinuing antibiotic therapy. Measures to prevent AAD include the use of probiotics. The rationale for the use of probiotics in AAD assumes that, considering the pathogenesis of AAD, AAD is associated with disturbance in the normal intestinal microbiota; administrating specific probiotic strains it is possible to normalize unbalanced indigenous microbiota.
Scientific evidence suggests that prebiotics could be beneficial too. Prebiotics can act in synergy with probiotics, being efficacious in suppressing the growth of pathogenic bacteria that may occur during antibiotic therapy.
Study rationale: the principal side effects of treatment with amoxicillin-clavulanate include diarrhoea, vomiting and allergic reactions. Aim of this study is to evaluate the effectiveness of the administration of a synbiotic product, Bio-Kult Infantis®, in the prevention of AAD during a standard therapy with amoxicillin-clavulanate to treat AOM.
Objective: to evaluate the effectiveness of a synbiotic product in the prevention of Antibiotics-Associated Diarrhoea (AAD) during a concomitant standard therapy with amoxicillin / clavulanic acid, also known as co-amoxiclav, to treat Acute Otitis Media (AOM).
Study design: this is a multicenter, double blind, parallel group, placebo controlled, randomized clinical study. 276 children 6 - 35 months old will be enrolled and then randomized into one of the two study groups (Bio-Kult Infantis® + co-amoxiclav standard treatment for AOM / placebo + co-amoxiclav standard treatment for AOM). A comparison will be performed to evaluate the effectiveness of a synbiotic product in the prevention of AAD during the concomitant standard therapy with co-amoxiclav.
During the study 4 visits will have to be performed at the study centre, and extra visits will be performed in case of AOM relapse after recovery. The study will last for each patient 38 ± 6 days.
|Condition or disease||Intervention/treatment||Phase|
|Acute Otitis Media||Dietary Supplement: Biokult Dietary Supplement: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||276 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
Treatment groups: 6 - 35 months old.
|Masking:||None (Open Label)|
|Masking Description:||A multicenter, double blind, parallel group, placebo controlled, randomized study.|
|Official Title:||Efficacy of a Synbiotic Product (Probiotics + Prebiotics) in the Prevention of Antibiotics-associated Diarrhoea (AAD) in Infants. A Multicenter, Double Blind, Parallel Group, Placebo Controlled, Randomized Study|
|Actual Study Start Date :||April 18, 2018|
|Estimated Primary Completion Date :||December 15, 2018|
|Estimated Study Completion Date :||December 15, 2018|
Active Comparator: Bio-Kult Infantis
1 sachet once a day mixed with milk, water or food.
Dietary Supplement: Biokult
Bio-Kult Infantis® is a multi-strain formula containing a probiotic formulation comprising 7 strains of probiotics, high content of Omega-3, Vitamin D3 and Preplex® (50% FOS and 50% gum acacia).
Each sachet contains:
Placebo Comparator: Placebo
1 sachet once a day mixed with milk, water or food.
Dietary Supplement: Placebo
IP placebo is manufactured so to contain maltodextrin DE19 and have the same organoleptic properties of the active product (similar to the study product in appearance and taste) but without active ingredient. It contains 100% maltodextrin DE19.
Moreover, placebo sachets are equal in color, shape and weight (1 g) to IP sachets.
- Incidence of AAD [ Time Frame: day 10 ]occurrence or non-occurrence of AAD according to time frame. An occurrence of AAD is defined as 3 or more watery stools in 1 day or 2 watery stools daily for at least 2 days
- Incidence of AAD [ Time Frame: Days 24 and 38 ]occurrence or non-occurrence of AAD according to time frame
- Duration of AAD [ Time Frame: Days 10, 24 and 38 ]Frequency (frequency of the occurrences as mean) of AAD according to time frame
- Mean stool consistency during antibiotic treatment [ Time Frame: from end of antibiotic treatment to Day 2, and from Day 24 to Day 38 ]Stool consistency evaluated according to the validated Infatl Stool Scale; mean values will be considered according to time frame
- Mean stool frequency [ Time Frame: Days 10, 24 and 38 ]Frequency of evacuations (frequency of the occurrences per 24 hours)
- Incidence and mean frequency of abdominal pain, nausea, vomiting, bloating, and appetite suppression [ Time Frame: Days 10, 24 and 38 ]Occurrence or non-occurrence and frequency of occurrences as mean according to time frame
- Time to resolution of AOM [ Time Frame: Day 38 ]Time (Days) to the first recording of an Acute Otitis Media Severity of Symptoms score (AOM-SOS Score) of 0 and 1 and the time to the second of two successive recordings of that score according to time frame
- Rate of resolution of AOM [ Time Frame: Days 10, 24 and 38 ]frequency of occurrences (resolution of AOM) as mean according to time frame
- Rate of residual middle-ear effusion (fluid behind the tympanic membrane) [ Time Frame: Days 10, 24 and 38 ]frequency of occurrences (residual middle-ear effusion) as mean according to time frame
- Rate of AOM relapse [ Time Frame: Days 24 and 38 ]frequency of occurrences (AOM relapse) as mean according to time frame
- Dermatitis in the diaper area (diaper rash) [ Time Frame: Days 10, 24 and 38 ]occurrence / or non-occurrence of dermatitis according to time frame
- Rate of interruption of antibiotic therapy [ Time Frame: Day 10 ]occurrence / or non-occurrence according to time frame
- Use of acetaminophen (as rescue medication) [ Time Frame: Day 38 ]Use of acetaminophen according to time frame
- Evaluation of product palatability [ Time Frame: Day 24 ]palatability valuated by parents / legal guardians by means of a VAS according to time frame
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03516409
|Contact: Ashton Harper, Dr.||+44 7712 321 033||Ashton.Harper@protexin.com|
|Contact: Cesare Mutti, Drfirstname.lastname@example.org|
|Hospital "Sandro Pertini"||Recruiting|
|Roma, Italia, Italy, 00157|
|Contact: Salvatore Tripodi, Dr|
|Principal Investigator:||Salvatore Tripodi, Dr||UOC pediatria Hospital "Sandro Pertini"|