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Active, Not Recruiting

NCT Number: NCT06094153

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Healthy Digestive System Diseases Gastrointestinal Diseases

Age range

40 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Singapore Institute for Clinical Trials

Singapore, 117609

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Dietary Supplement

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

HMO 1

Dietary Supplement

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

HMO 2

Dietary Supplement

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

Primary outcomes

  1. Relative abundance of Bifidobacterium in the gut

    Time frame: 4 weeks

Secondary outcomes

  1. Relative abundance of other bacterial taxa in the gut

    Time frame: 4 weeks

  2. Gut microbiome functional potential (functional metagenomics analyses)

    Time frame: 4 weeks

  3. Stool Human Milk Oligossacharides level

    Time frame: 4 weeks

  4. Concentration of immune parameters panel in blood (OLINK Target 96 Inflammation panel)

    Time frame: 4 weeks

Other outcomes

  1. Gastrointestinal Symptoms Questionnaire

    Time frame: 4 weeks

  2. Depression Anxiety Stress Scale (DASS)-21 items

    Time frame: 4 weeks

  3. Digestion-associated Quality of Life Questionnaire (DQLQ)

    Time frame: 4 weeks

  4. Bristol stool chart

    Time frame: 4 weeks

    Stool consistency ranging from Type 1 to Type 7

  5. Clinical chemistry and haematology analyses for safety analysis

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Kyowa Hakko Bio Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Oct 23, 2023
Registry last updated
Feb 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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