NL-OMON52353RecruitingNot Applicable
Toddlers receiving synbiotics after antibiotics - TOBBI trial
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Wageningen Universiteit
- Enrollment
- 166
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 0 to 11 (—)
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.
Investigators
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