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This study is initiated to investigate the effect of infant formula with added specific synbiotics mixture on proportion of beneficial bacteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group I | Active Comparator | Regular non-hydrolysed cow's milk based infant formula with synbiotics mixture I |
|
| Interventional Group II | Active Comparator | Regular non-hydrolysed cow's milk based infant formula with synbiotics mixture II |
|
| Control Group | Placebo Comparator | Regular non-hydrolysed cow's milk based infant formula |
|
| Reference Group | No Intervention | Exclusively breast-fed infants |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regular non-hydrolysed cow's milk I | Other | Regular non-hydrolysed cow's milk based infant formula with synbiotics mixture I |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of Baseline proportion of beneficial bacteria at week 6 in interventional group compared to the change in control group | baseline, week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change of proportion of baseline beneficial bacteria at week 6 in interventional group I compared to the change in control group | baseline, week 6 | |
| Change of Baseline proportion of beneficial bacteria at week 6 in interventional group II compared to the change in control group |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thammasat Hospital | Klong Luang | Changwat Pathum Thani | Thailand | |||
| King Chulalongkorn Memorial Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33574421 | Derived | Phavichitr N, Wang S, Chomto S, Tantibhaedhyangkul R, Kakourou A, Intarakhao S, Jongpiputvanich S; COLOR Study Group; Roeselers G, Knol J. Impact of synbiotics on gut microbiota during early life: a randomized, double-blind study. Sci Rep. 2021 Feb 11;11(1):3534. doi: 10.1038/s41598-021-83009-2. |
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| Regular non-hydrolysed cow's milk II | Other | Regular non-hydrolysed cow's milk based infant formula with synbiotics mixture II |
|
| Regular non-hydrolysed cow's milk - control | Other | Regular non-hydrolysed cow's milk based infant formula without synbiotics mixture |
|
| baseline, week 6 |
| Bangkok |
| Thailand |
| Phramongkutklao Hospital | Bangkok | Thailand |