Toddlers receiving synbiotics after antibiotics

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 156

Inclusion Criteria

Study participants (n=126):
1.Written informed consent obtained from both caregivers;
2.Caregivers are willing to comply with the requirements of the study;
3.Age 1-2 year old at the time of enrollment;
4.Drinks cow’s milk (non-fat, semi-skimmed or full fat) on a daily basis;
5.Received a prescription for amoxicillin.

Age-matched control group (n=30):
1.Written informed consent obtained from both caregivers;
2.Caregivers are willing to comply with the requirements of the study;
3.Age 1 year old;

Exclusion Criteria

Study participants (n=126):
1.Any 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.Used pre-or probiotic supplements or food products with added pre- or probiotics (e.g. formula containing GOS or FOS, Activia, Actimel, Yakult, etc.) in the last 7 days before start of the antibiotic treatment;
5.Is receiving breastmilk, or has received breastmilk in the last 7 days before start of antibiotic treatment.

Age-matched control group (n=30):
1.Any 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.Used pre-or probiotic supplements or food products with added pre- or probiotics (e.g. formula containing GOS or FOS, Activia, Actimel, Yakult, etc.) in the last 7 days before start of the antibiotic treatment;
5.Has received any broad-spectrum antibiotic treatment at any time in his/her life.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures