This study was a 28-day, open-label, randomized controlled trial involving infants and toddlers diagnosed with functional constipation. Participants were randomized to receive either Bifidobacterium longum subsp. longum Dipro-X, lactulose, or a combination of both. The primary clinical outcomes assessed were bowel movement frequency, stool consistency, and defecation difficulty. To investigate potential mechanisms, stool samples were collected pre- and post-intervention for metagenomics sequencing to analyze changes in gut microbiota composition and identify specific bacterial taxa associated with clinical improvements.
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Defecation difficulty in young children upon administration of probiotic, lactulose or their combinations as assessed via Visual Anologue Scale (VAS)
Timeframe: Day-0, day-14, day-28
Bowel movement frequency in young children upon administration of probiotic, lactulose or their combinations as assessed via patients' diary
Timeframe: Day-0, day-28
Bristol stool score in young children upon administration of probiotic, lactulose or their combinations as assessed via Bristol stool chart
Timeframe: Day-0, day-14, day-28