Randomized, Double-Blind, Placebo-Controlled Parallel Clinical Trial Assessing the Effect of Fructooligosaccharides...

Area of Science:

• Pediatric Gastroenterology
• Microbiology
• Nutrition Science

Background:

• Infant constipation is a common condition, often emerging within the first year of life.
• Understanding effective, safe interventions for infant constipation is crucial for infant well-being.

Purpose of the Study:

• To evaluate the efficacy of fructooligosaccharides (FOS) as a treatment for constipation in infants.
• To assess the impact of FOS on stool consistency, straining, gut transit time, and fecal microbiota composition.

Main Methods:

• A randomized, double-blind, placebo-controlled trial was conducted with infants diagnosed with constipation.
• Participants were assigned to receive either FOS or a placebo mixed with their infant formula for 4 weeks.
• Outcomes measured included therapeutic success rates, stool characteristics, mouth-to-anus transit time, and Bifidobacterium counts.

Main Results:

• The FOS group showed a higher frequency of softer stools (p=0.035) and fewer episodes of straining (p=0.041) compared to placebo.
• Mouth-to-anus transit time was significantly shorter in the FOS group (p=0.035).
• Fecal analysis revealed a significantly higher count of Bifidobacterium sp. in infants receiving FOS (p=0.006).

Conclusions:

• Fructooligosaccharides (FOS) supplementation demonstrated a positive effect on key symptoms of constipation in infants.
• While overall therapeutic success did not reach statistical significance (p=0.073), FOS improved stool consistency and reduced straining.
• FOS administration led to a reduced bowel transit time and an increase in beneficial Bifidobacterium in the infant gut microbiota.