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The aim of this study is to evaluate the bifidogenic effect and other potentially beneficial effects on the microbiome of GOS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Milk powder without GOS | Placebo Comparator |
| |
| Milk powder with GOS | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Milk powder | Dietary Supplement | one sachet per day dissolved in 200 ml of water |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Bifidobacteria in the stools | Measured by Next Generation Sequencing (NGS) | Throughout 14 days of product intake |
| Measure | Description | Time Frame |
|---|---|---|
| Change in quality of life using SF-36 questionnaire (Short Form 36 Health Survey) | SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting and are now widely utilized by managed care organizations and by Medicare for routine monitoring and assessment of care outcomes in adult patients. Score ranging from 0 to 100 (higher scores indicate better health status). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Innovation Lab | Lausanne | Canton of Vaud | 1000 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40909168 | Derived | Siegwald L, Cherta-Murillo A, Christen S, Boulange CL, Chou CJ, Foata F, Lahiry A, Frezal A, Giner MP, Godin JP, Sakwinska O. The Impact of Low-Lactose, High Galacto-Oligosaccharides Milk on Gut Microbiome and Plasma Metabolome in Healthy Adults: A Randomized, Double-Blind, Controlled Clinical Trial Complemented by Ex Vivo Experiments. Curr Dev Nutr. 2025 Jul 24;9(9):107506. doi: 10.1016/j.cdnut.2025.107506. eCollection 2025 Sep. |
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| ID | Term |
|---|---|
| C057917 | Refit milk powder |
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| Throughout 14 days of product intake |
| Change in Short Chain Fatty Acids (SCFA) in the plasma | The SFCA are measured in the plasma using Liquid Chromatography with tandem mass spectrometry (LC-MSMS) | Throughout 14 days of product intake |
| Gastrointestinal Symptom Rating Scale (GSRS) | Validated questionnaire exploring the presence and severity of GI symptoms over the previous 7 days. The GSRS is a disease-specific instrument of 15 items combined into five symptom clusters depicting reflux, abdominal pain, indigestion, diarrhea and constipation. The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms. The effect of the interventions on the GSRS will be assessed by a linear mixed model and will take into account information on this from all 7 days of treatment. | Throughout 14 days of product intake |
| Change in Short Chain Fatty Acids (SCFA) in the stool | Measured using Gas Chromatography (GC) | Throughout 14 days of product intake |