search
Back to results

Prebiotic Effects on Gut Microbiota, Gut Comfort and Immune Function

Primary Purpose

Healthy, Gastrointestinal Diseases

Status
Recruiting
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Placebo
HMO 1
HMO 2
Sponsored by
Kyowa Hakko Bio Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Healthy focused on measuring Prebiotics

Eligibility Criteria

40 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Singapore Institute for Clinical TrialsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

HMO 1

HMO 2

Arm Description

Outcomes

Primary Outcome Measures

Relative abundance of Bifidobacterium in the gut

Secondary Outcome Measures

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

Full Information

First Posted
July 11, 2023
Last Updated
October 16, 2023
Sponsor
Kyowa Hakko Bio Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT06094153
Brief Title
Prebiotic Effects on Gut Microbiota, Gut Comfort and Immune Function
Official Title
Randomized Controlled Trial on Prebiotic Effects on Gut Microbiota, Gut Comfort and Immune Function
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kyowa Hakko Bio Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Gastrointestinal Diseases
Keywords
Prebiotics

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
108 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
HMO 1
Arm Type
Experimental
Arm Title
HMO 2
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Consume placebo (Maltodextrin) once daily before going to bed for 28 days
Intervention Type
Dietary Supplement
Intervention Name(s)
HMO 1
Intervention Description
Consume HMO 1 (Dietary supplement) once daily before going to bed for 28 days
Intervention Type
Dietary Supplement
Intervention Name(s)
HMO 2
Intervention Description
Consume HMO 2 (Dietary supplement) once daily before going to bed for 28 days
Primary Outcome Measure Information:
Title
Relative abundance of Bifidobacterium in the gut
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Relative abundance of other bacterial taxa in the gut
Time Frame
4 weeks
Title
Gut microbiome functional potential (functional metagenomics analyses)
Time Frame
4 weeks
Title
Stool Human Milk Oligossacharides level
Time Frame
4 weeks
Title
Concentration of immune parameters panel in blood (OLINK Target 96 Inflammation panel)
Time Frame
4 weeks
Other Pre-specified Outcome Measures:
Title
Gastrointestinal Symptoms Questionnaire
Time Frame
4 weeks
Title
Depression Anxiety Stress Scale (DASS)-21 items
Time Frame
4 weeks
Title
Digestion-associated Quality of Life Questionnaire (DQLQ)
Time Frame
4 weeks
Title
Bristol stool chart
Description
Stool consistency ranging from Type 1 to Type 7
Time Frame
4 weeks
Title
Clinical chemistry and haematology analyses for safety analysis
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eri Nakazaki, PhD
Phone
+818071285540
Email
eri.nakazaki@kyowa-kirin.co.jp
First Name & Middle Initial & Last Name or Official Title & Degree
Jeroen Schmitt, PhD
Email
Jeroen_Schmitt@sics.a-star.edu.sg
Facility Information:
Facility Name
Singapore Institute for Clinical Trials
City
Singapore
ZIP/Postal Code
117609
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeroen Schmitt, PhD
Phone
+65 6407 4060
Email
jeroen_schmitt@sics.a-star.edu.sg

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35040200
Citation
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.
Results Reference
background
PubMed Identifier
27719686
Citation
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.
Results Reference
background

Learn more about this trial

Prebiotic Effects on Gut Microbiota, Gut Comfort and Immune Function

We'll reach out to this number within 24 hrs