Oral antibiotic therapy Infections and Infestations
Conditions
Interventions
Participants randomised to active or placebo group will take study products orally once daily for 30 days:
1. The active will contain Lab4 probiotic consortium (Lactobacillus acidophilus CUL60, Lactob
Sponsors
Cultech Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Children aged 3 to 18 years old of either sex with infections requiring treatment by one of the following classes of antibiotics: cephalosporins; clarithromycin and amoxicllins/clavulanic acids 2. Participants willing to provide saliva, urine and stool samples 3. Parents/guardians willing to give written informed consent and information on children's daily bowel habits
Exclusion criteria
Exclusion criteria: 1. Participants whose parents are unable/unwilling to give written formal consent 2. Participants not prepared to provide saliva, urine and stool samples 3. Participants who took antibiotics in the 4 weeks prior to enrolment 4. Participants sensitive to xylitol or sorbitol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Changes in the composition and diversity of gut microbiota 2. Changes in metabonomic profiles. Stool and urine samples to be taken within 24 hours of first antibiotic dose, on the day of last antibiotic dose and on last day of active or placebo intervention dose at day 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Impact of probiotics on wellbeing (changes in bowel habits, blood pressure, etc) 2. Changes in composition and diversity of oral microbiota 3. Stool and saliva samples at baseline, completion of antibiotic course and upon completion of the probiotic or placebo intervention at day 30 | — |
Countries
Slovakia
Outcome results
None listed