NCT04791956

Prebiotic EffecT InfanTs

Double-blind, Randomized Placebo-controlled Trial Investigating the Effect of Prebiotic Inulin-type Fructans on Bowel Habits of Infants

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Beneo-Institute · Industry
• Sex: All
• Age: 6 Months – 12 Months
• Healthy volunteers: Accepted

Summary

The study aims to confirm the effectiveness of chicory-derived prebiotic inulin-type fructans on stool consistency in infants.

Detailed description

The fermentation of prebiotic inulin-type fructans leads to a modulation of the gut microbiota composition, in particular to a growth stimulation of bifidobacteria, and the production of organic acids like lactate and short-chain fatty acids (SCFA). The introduction of solid foods is frequently associated with harder stools which are more difficult to pass and can cause painful defecations. Subsequently, the changes in bowel habits associated with weaning and the introduction of complementary foods could be minimized by the addition of prebiotics to complementary foods and, thus, the transition from milk-feeding to family food could be facilitated.

Conditions

• Infant Development
• Healthy
• Diet, Healthy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Prebiotic	Daily intake of Inulin-type fructans from chicory
DIETARY_SUPPLEMENT	Placebo	Daily intake of maltodextrin

Timeline

• Start date: 2021-03-17
• Primary completion: 2024-06-01
• Completion: 2024-06-01
• First posted: 2021-03-10
• Last updated: 2023-04-12

Locations

2 sites across 1 country: Spain