HealthyNCT06094153
Prebiotic Effects on Gut Microbiota, Gut Comfort and Immune Function
A study testing HMO 1 and HMO 2 in people with Healthy and Gastrointestinal Diseases, run by Kyowa Hakko Bio Co., Ltd. at 1 site in Singapore.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Gastrointestinal Diseases
- What is being tested?
- HMO 1 and HMO 2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteSingapore
- Study dates
- 4 Oct 2023to Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Placebo, HMO 1, HMO 2
- Keywords
- Prebiotics
- Medical subject headings
- Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Consume placebo (Maltodextrin) once daily before going to bed for 28 days
HMO 1Dietary supplement
Consume HMO 1 (Dietary supplement) once daily before going to bed for 28 days
HMO 2Dietary supplement
Consume HMO 2 (Dietary supplement) once daily before going to bed for 28 days
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
| HMO 1 | Experimental | Not described Receives: Dietary Supplement: HMO 1 |
| HMO 2 | Experimental | Not described Receives: Dietary Supplement: HMO 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative abundance of Bifidobacterium in the gut
Measured: 4 weeks
Secondary outcomes (4)
Relative abundance of other bacterial taxa in the gut
Measured: 4 weeks
Gut microbiome functional potential (functional metagenomics analyses)
Measured: 4 weeks
Stool Human Milk Oligossacharides level
Measured: 4 weeks
Concentration of immune parameters panel in blood (OLINK Target 96 Inflammation panel)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start4 Oct 2023
- Primary completion2 Sep 2024
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyowa Hakko Bio Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06094153
- Sponsor's protocol ID
- 2023-005
- Status last verified
- Feb 2025
- First submitted
- 11 Jul 2023
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35040200Elison 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.
PubMed 27719686
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial on Prebiotic Effects on Gut Microbiota, Gut Comfort and Immune Function
- ClinicalTrials.gov ID
- NCT06094153
- Acronym / sponsor ID
- 2023-005
- Conditions
- Healthy, Gastrointestinal Diseases
- Keywords
- Prebiotics
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Kyowa Hakko Bio Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Oct 2023 (actual)
- Primary completion
- 2 Sep 2024 (actual)
- Study completion
- Sep 2025 (estimated)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
| HMO 1 | Experimental | Dietary Supplement: HMO 1 |
| HMO 2 | Experimental | Dietary Supplement: HMO 2 |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboConsume placebo (Maltodextrin) once daily before going to bed for 28 days | Dietary supplement | Placebo |
| HMO 1Consume HMO 1 (Dietary supplement) once daily before going to bed for 28 days | Dietary supplement | HMO 1 |
| HMO 2Consume HMO 2 (Dietary supplement) once daily before going to bed for 28 days | Dietary supplement | HMO 2 |
Primary outcome
Relative abundance of Bifidobacterium in the gut
Time frame: 4 weeks
4 secondary outcomes
Relative abundance of other bacterial taxa in the gut
Time frame: 4 weeks
Gut microbiome functional potential (functional metagenomics analyses)
Time frame: 4 weeks
Stool Human Milk Oligossacharides level
Time frame: 4 weeks
Concentration of immune parameters panel in blood (OLINK Target 96 Inflammation panel)
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Background: PubMed 35040200Sprenger 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.
- Background: PubMed 27719686Elison 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.
- Individual participant dataSharing planned: No
Related trials for Healthy
RecruitingObservational study
Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making
Healthy Volunteers
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Healthy Volunteer
Active, not recruitingPhase 3
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
Pneumococcal Disease
Recruiting
Effect of a Fermented Dairy Protein With Prebiotic Fiber on GI Complaints
Digestive Health, Quality of Life
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HMO 1 and HMO 2 in people with Healthy and Gastrointestinal Diseases, run by Kyowa Hakko Bio Co., Ltd. at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative abundance of Bifidobacterium in the gut (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06094153, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025.