Prebiotic Effects on Gut Microbiota, Gut Comfort and Immune Function

NCT06094153 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2025-02-05

No results posted yet for this study

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.

Conditions

  • Healthy
  • Gastrointestinal Diseases

Interventions

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

Sponsors & Collaborators

  • Kyowa Hakko Bio Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-04
Primary Completion
2024-09-02
Completion
2025-09-30

Countries

  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06094153 on ClinicalTrials.gov