Toddlers receiving synbiotics after antibiotics

Recruiting

Conditions: 10018012
Antibiotic use for bacterial infections
10004018

Registration Number: NL-OMON52353

Lead Sponsor: Wageningen Universiteit

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 166

Inclusion Criteria

1. Written informed consent obtained from both caregivers;
2. Caregivers are willing to comply with the requirements of the study;
3. Aged 1 to 4 years old at the time of enrollment;
4. Drinks cow*s milk (non-fat, semi-skimmed or full fat) regularly;
5. Received a prescription for amoxicillin or amoxicillin / clavulanic acid*.
* There are no restrictions on use of any (other) antibiotics earlier in life.

Exclusion Criteria

1. Any gastro-intestinal (GI) complaints, known structural GI abnormalities, or
previous GI surgery;
2. Clinically significant cardiac, vascular, liver, pulmonary, psychiatric
disorders, severe renal insufficiency, human immunodeficiency virus infection,
acquired immunodeficiency syndrome, hepatitis B or C or abnormalities of
haematology, urinalysis, or blood biochemistry;
3. Known to have an allergy or intolerance to any of the ingredients in the
study- or control product, including lactose and cow*s milk protein;
4. Is receiving breastmilk, or has received breastmilk in the last 7 days
before start of antibiotic treatment.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Proportion of all species belonging to the genus Bifidobacterium out of total<br /><br>species, at t=0, t=21, t=42 and t=84 days, based on qPCR, ITS and 16s rDNA<br /><br>sequencing data.<br /><br>- Composition of all species belonging to the genus Bifidobacterium at t=0,<br /><br>t=21, t=42 and t=84 days, based on qPCR, ITS and 16s rDNA sequencing data. </p><br>

Secondary Outcome Measures