Effect of probiotics following antibiotic therapy

Completed

• Conditions: Oral antibiotic therapy; Infections and Infestations

• Registration Number: ISRCTN16359093
• Lead Sponsor: Cultech Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-07
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 78

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Changes in the composition and diversity of gut microbiota<br>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 Outcome Measures

Name	Time	Method
1. Impact of probiotics on wellbeing (changes in bowel habits, blood pressure, etc)<br>2. Changes in composition and diversity of oral microbiota<br>3. Stool and saliva samples at baseline, completion of antibiotic course and upon completion of the probiotic or placebo intervention at day 30