Prebiotic Effects on Gut Microbiota, Gut Comfort and Immune Function

NCT06094153 | Active Not Recruiting DMC

• 1 other identifier: 2023-005
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy; Gastrointestinal Diseases

Keywords

Prebiotics

Outcome Measures

Primary Outcomes (1)

• Relative abundance of Bifidobacterium in the gut

  4 weeks

Secondary Outcomes (4)

• 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 Outcomes (5)

• Gastrointestinal Symptoms Questionnaire

  4 weeks

• Depression Anxiety Stress Scale (DASS)-21 items

  4 weeks

• Digestion-associated Quality of Life Questionnaire (DQLQ)

  4 weeks

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

HMO 1

EXPERIMENTAL

Dietary Supplement: HMO 1

HMO 2

EXPERIMENTAL

Dietary Supplement: HMO 2

Interventions

Placebo DIETARY_SUPPLEMENT

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

Placebo

HMO 1 DIETARY_SUPPLEMENT

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

HMO 1

HMO 2 DIETARY_SUPPLEMENT

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

HMO 2

Eligibility Criteria

• Age: 40 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kyowa Hakko Bio Co., Ltd.: lead

Study Sites (1)

Singapore Institute for Clinical Trials

Singapore, 117609, Singapore

Location

Related Publications (2)

• 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.

  PMID: 35040200 BACKGROUND

• 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.

  PMID: 27719686 BACKGROUND

MeSH Terms

Conditions

Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2023
• First Posted: October 23, 2023
• Study Start: October 4, 2023
• Primary Completion: September 2, 2024
• Study Completion: September 1, 2025
• Last Updated: February 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)