Prebiotic Effects on Gut Microbiota, Gut Comfort and Immune Function

NCT ID: NCT06094153

Last Updated: 2025-02-05

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-04
• Study Completion Date: 2025-09-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Consume placebo (Maltodextrin) once daily before going to bed for 28 days

HMO 1

Group Type: EXPERIMENTAL

HMO 1

Intervention Type: DIETARY_SUPPLEMENT

Consume HMO 1 (Dietary supplement) once daily before going to bed for 28 days

HMO 2

Group Type: EXPERIMENTAL

HMO 2

Intervention Type: DIETARY_SUPPLEMENT

Consume HMO 2 (Dietary supplement) once daily before going to bed for 28 days

Interventions

Placebo

Consume placebo (Maltodextrin) once daily before going to bed for 28 days

Intervention Type: DIETARY_SUPPLEMENT

HMO 1

Consume HMO 1 (Dietary supplement) once daily before going to bed for 28 days

Intervention Type: DIETARY_SUPPLEMENT

HMO 2

Consume HMO 2 (Dietary supplement) once daily before going to bed for 28 days

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Age ≥ 40 and ≤ 55 years
• Male/female
• Total score of >2 on the Gastrointestinal Symptom Rating Scale (GSRS)
• Body Mass Index 18-30 kg/m2
• Stable body weight (± 5%) for at least 6 months
• Stable lifestyle and dietary habits within the 4 weeks prior and during study period
• Owns device (computer, smartphone, tablet) with access to the internet
• Adequate fluency in the English language to understand the inform consent process, study instructions and study assessments
• Sufficient vision and hearing to complete study procedures
• Willing and able to participate, follow the study procedures and to give written informed consent

Exclusion Criteria

• History (< 6 months prior to the study) or presence of severe gastrointestinal, metabolic, immunological, psychiatric disorder, or major surgery
• Current or past (< 4 weeks) use of prescription, over-the-counter, or traditional medication, or dietary supplements with a relevant impact on GI system or on visceral motility
• Having received antibiotic treatment < 4 weeks prior to study
• Alcohol intake >1 units/day
• Currently pregnant or pregnancy in past 6 months
• Use of pro/prebiotics < 4 weeks prior to study start
• Fully vegetarian/vegan diet < 4 weeks prior to study start
• High habitual vegetable and fruit intake (> 2 servings of fruits and >2 servings of vegetables per day) < 4 weeks prior to study start
• Lactose intolerance
• Maltodextrin allergy
• Members of the research team or their immediate family members. Immediate family member is defined as spouse, parent, child, or sibling, whether biological or legally adopted

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kyowa Hakko Bio Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Singapore Institute for Clinical Trials

Singapore, , Singapore

Countries

Singapore

References

Sprenger N, Tytgat HLP, Binia A, Austin S, Singhal A. Biology of human milk oligosaccharides: From basic science to clinical evidence. J Hum Nutr Diet. 2022 Apr;35(2):280-299. doi: 10.1111/jhn.12990. Epub 2022 Feb 2.

Reference Type: BACKGROUND

PMID: 35040200 (View on PubMed)

Elison E, Vigsnaes LK, Rindom Krogsgaard L, Rasmussen J, Sorensen N, McConnell B, Hennet T, Sommer MO, Bytzer P. Oral supplementation of healthy adults with 2'-O-fucosyllactose and lacto-N-neotetraose is well tolerated and shifts the intestinal microbiota. Br J Nutr. 2016 Oct;116(8):1356-1368. doi: 10.1017/S0007114516003354. Epub 2016 Oct 10.

Reference Type: BACKGROUND

PMID: 27719686 (View on PubMed)

Other Identifiers

2023-005

Identifier Type: -

Identifier Source: org_study_id