Bio-Kult Infantis® in AAD Prevention in Infants

NCT03516409 | Unknown

• 1 other identifier: AAD_BKI_001
• Study Type: interventional
• Target: 276
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Otitis Media

Keywords

probiotics; prebiotics; diarrhoea

Outcome Measures

Primary Outcomes (1)

• Incidence of AAD

  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

  day 10

Secondary Outcomes (13)

• Incidence of AAD

  Days 24 and 38

• Duration of AAD

  Days 10, 24 and 38

• Mean stool consistency during antibiotic treatment

  from end of antibiotic treatment to Day 2, and from Day 24 to Day 38

• Mean stool frequency

  Days 10, 24 and 38

• Incidence and mean frequency of abdominal pain, nausea, vomiting, bloating, and appetite suppression

  Days 10, 24 and 38

Study Arms (2)

Bio-Kult Infantis

ACTIVE COMPARATOR

1 sachet once a day mixed with milk, water or food.

Dietary Supplement: Biokult

Placebo

PLACEBO COMPARATOR

1 sachet once a day mixed with milk, water or food.

Dietary Supplement: Placebo

Interventions

Biokult DIETARY_SUPPLEMENT

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: * Minimum 1 billion microorganisms per sachet (1 x 109CFU/g), guaranteed throughout the shelf life * DHA + EPA: \>1mg per sachet * Vitamin D3: 2.5mcg per sachet (50% of Nutrient Reference Value). Bio-Kult Infantis® presents itself in the form of a white powder, packaged in sachets of 1 g each

Bio-Kult Infantis

Placebo DIETARY_SUPPLEMENT

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.

Placebo

Eligibility Criteria

• Age: 6 Months - 35 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• \. Parents / legal guardians signed written informed consent to participate in the study.
• \. Male and female infants aged 6 - 35 months (6 and 35 inclusive).
• \. Infants eligible to receive co-amoxiclav to treat AOM according to current Italian guidelines, edited by Società Italiana di Pediatria, 2012.
• \. Outpatients infants (not hospitalized).
• \. Infants who have received at least 2 doses of pneumococcal conjugate vaccine.
• \. Infants diagnosed with Acute Otitis Media (AOM) based on the following three criteria:
• onset, within the preceding 48 hours, of symptoms that parents or legal guardians rated with a score of at least 3 on the Acute Otitis Media Severity of Symptoms (AOM - SOS);
• presence of middle-ear effusion;
• moderate or marked bulging of the tympanic membrane or slight bulging accompanied by either otalgia or marked erythema of the membrane
• \. Infants already exposed to formula milk without Cow Milk Protein Allergy (CMPA) (not requiring a formal diagnosis of CMPA).

You may not qualify if:

• \. Infants with any other acute illness apart from AOM (e.g. pneumonia) or with any other chronic illness (e.g. cystic fibrosis).
• \. Infants with a clinical history positive for any allergy or intolerance to amoxicillin, clavulanic acid or any component of the active product, the placebo or of the rescue medication (acetaminophen).
• \. Infants presenting contraindications to the study products, to co-amoxiclav or to the rescue medication, according to concerning Summaries of Product Characteristics (SPC).
• \. Infants being treated with any drug whose pharmacokinetics can interfere with the intake of amoxicillin, clavulanic acid, the study products or the rescue medication or with any drug with which amoxicillin, clavulanic acid, the study products or the rescue medication can interact, according to concerning Summaries of Product Characteristics (SPC).
• \. Infants with a clinical history positive for allergy to any other antibiotics.
• \. Infants who have received antibiotics within 8 weeks prior to enrollment.
• \. Infants who have had otalgia for longer than 48 hours or perforation of the tympanic membrane.
• \. Infants suffering from active diarrhoea at time of enrollment or chronic diarrhoea.
• \. Infants who consumed a probiotic product for medicinal purposes within 7 days prior to enrollment.
• \. Unwillingness on the part of the parents or legal guardians to interrupt any regular intake of other probiotics during the study period
• \. Diagnosis of Clostridium difficile-associated diarrhoea (CDAD) within the previous three months from enrolment

Sponsors & Collaborators

• Probiotics International Ltd.: lead
• Sprim Advanced Life Sciences: collaborator

Study Sites (1)

Hospital "Sandro Pertini"

Roma, Italia, 00157, Italy

RECRUITING

MeSH Terms

Conditions

Otitis Media; Diarrhea

Condition Hierarchy (Ancestors)

Otitis; Ear Diseases; Otorhinolaryngologic Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Salvatore Tripodi, Dr

  UOC pediatria Hospital "Sandro Pertini"

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashton Harper, Dr.

CONTACT

+44 7712 321 033; Ashton.Harper@protexin.com

Cesare Mutti, Dr

CONTACT

+390245495838; cesare.mutti@sprim.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: A multicenter, double blind, parallel group, placebo controlled, randomized study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Treatment groups: 6 - 35 months old. * Bio-Kult Infantis * Placebo (maltodextrine DE19)

Study Record Dates

• First Submitted: April 19, 2018
• First Posted: May 4, 2018
• Study Start: April 18, 2018
• Primary Completion: December 15, 2018
• Study Completion: December 15, 2018
• Last Updated: September 12, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)