Received amoxicilline treatment for treatment of bacterial infection
Conditions
Interventions
Young child formula supplemented with synbiotics vs regular cow's milk
Sponsors
Wageningen University
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - 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. - 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1a. Proportion of bifidobacteria by qPCR at t=0, t=7, t= 14, t=28, t=35, t=49, t=56, t=63, t=70, t=77 and t=84 days;. b. Total microbiota composition by 16s rDNA sequencing at t=0,t=21, t=42 and t=84 days; c. Faecal pH and short-chain fatty acid (SCFA) levels of faecal samples at t=0 to t=21, t=42 and t=84 days; d. Stool characteristics: consistency and frequency as reported in a weekly diary using modified Bristol Stool Form Scale; e. Gastrointestinal symptoms, deviating from normal, as documented in a weekly diary. 2. The proportion and composition of bifidobacteria and total microbiota composition in the intervention- and control group compared to the age matched group. Other endpoints 1. The amount of study product and cow’s milk consumed for compliance, as reported in the diary; 2. Habitual dietary intake assessed with an FFQ of participants and its association with proportion bifidobacteria at 42 and 84 days; 3. Habitual dietary intake assessed with an FFQ of the participants and its association with microbiota composition at 42 and 84 days; 4. Habitual dietary intake assessed with an FFQ of the participants and its association with stool characteristics at 42 and 84 days; Explorative study endpoints • Total microbiota composition, bifidobacteria specific ITS sequence, faecal pH and SCFA composition, at all timepoints; • Total microbiota composition and bifidobacteria specific ITS sequence at t=0 to t=21, t=42 and t=84 days assessed per breastfeeding duration group (e.g. no breastfeeding, breastfeeding up to 3, 6, 9 or 12 months after birth). | — |
Contacts
Public ContactClara Belzer
Universiteit van Wageningen
Outcome results
None listed