NCT06094153

Prebiotic Effects on Gut Microbiota, Gut Comfort and Immune Function

Randomized Controlled Trial on Prebiotic Effects on Gut Microbiota, Gut Comfort and Immune Function

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Kyowa Hakko Bio Co., Ltd. · Industry
• Sex: All
• Age: 40 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Human Milk Oligosaccharides (HMOs) are the third most abundant class of nutrients in human milk. Studies investigating the effects of dietary HMOs in infants have shown various health and developmental benefits such as the development of the early gut microbiome (by favouring colonisation of beneficial Bifidobacterium, Lactobacillus, and Bacteroides), the development of the immune system, general infant growth, protection against infectious diseases and allergies, and stimulation of cognitive development. Only a limited number of studies have been conducted in adults, showing intake of HMOs stimulates the growth of gut Bifidobacterium in healthy adults.

Detailed description

The current study aims to investigate the effects of a 4-week intervention with two HMOs on gut microbiome composition, immune function and gastrointestinal symptoms in healthy adults with mild to moderate gastrointestinal complaints. The study will be conducted as a partially decentralized, double-blind, randomized, placebo-controlled, parallel group design.

Conditions

• Healthy
• Gastrointestinal Diseases

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Placebo	Consume placebo (Maltodextrin) once daily before going to bed for 28 days
DIETARY_SUPPLEMENT	HMO 1	Consume HMO 1 (Dietary supplement) once daily before going to bed for 28 days
DIETARY_SUPPLEMENT	HMO 2	Consume HMO 2 (Dietary supplement) once daily before going to bed for 28 days

Timeline

• Start date: 2023-10-04
• Primary completion: 2024-09-02
• Completion: 2025-09-01
• First posted: 2023-10-23
• Last updated: 2025-02-05

Locations

1 site across 1 country: Singapore