Prebiotic Effects on Gut Microbiota, Gut Comfort and Immune Function

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Gastrointestinal Diseases; Healthy
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: HMO 1; Dietary supplement: HMO 2

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.

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 117609
    • Singapore Institute for Clinical Trials

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Placebo; Consume placebo (Maltodextrin) once daily before going to bed for 28 days
Experimental: HMO 1	Dietary supplement: HMO 1; Consume HMO 1 (Dietary supplement) once daily before going to bed for 28 days
Experimental: HMO 2	Dietary supplement: HMO 2; Consume HMO 2 (Dietary supplement) once daily before going to bed for 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Relative abundance of Bifidobacterium in the gut	4 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Relative abundance of other bacterial taxa in the gut	4 weeks
Gut microbiome functional potential (functional metagenomics analyses)	4 weeks
Stool Human Milk Oligossacharides level	4 weeks
Concentration of immune parameters panel in blood (OLINK Target 96 Inflammation panel)	4 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastrointestinal Symptoms Questionnaire		4 weeks
Depression Anxiety Stress Scale (DASS)-21 items		4 weeks
Digestion-associated Quality of Life Questionnaire (DQLQ)		4 weeks
Bristol stool chart	Stool consistency ranging from Type 1 to Type 7	4 weeks
Clinical chemistry and haematology analyses for safety analysis		4 weeks

Collaborators and Investigators

• Sponsor: Kyowa Hakko Bio Co., Ltd.

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2023
• Primary Completion (Actual): September 2, 2024
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: July 11, 2023
• First Submitted That Met QC Criteria: October 16, 2023
• First Posted (Actual): October 23, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 4, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Prebiotics
• Additional Relevant MeSH Terms: Gastrointestinal Diseases; Digestive System Diseases
• Other Study ID Numbers: 2023-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No