The aim of this study is to evaluate the bifidogenic effect and other potentially beneficial effects on the microbiome of GOS.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
26
one sachet per day dissolved in 200 ml of water
Clinical Innovation Lab
Lausanne, Canton of Vaud, Switzerland
Proportion of Bifidobacteria in the stools
Measured by Next Generation Sequencing (NGS)
Time frame: Throughout 14 days of product intake
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).
Time frame: 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)
Time frame: 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.
Time frame: Throughout 14 days of product intake
Change in Short Chain Fatty Acids (SCFA) in the stool
Measured using Gas Chromatography (GC)
Time frame: Throughout 14 days of product intake
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