Gastrointestinal Microbiome (Focus)myBIOMNCT07453823
The Effect of a Synbiotic on Intestinal Barrier Function and Microbiota Modulation in Middle-aged to Elderly Individuals With Excessive Body Weight
A study testing Synbiotic in people with Gastrointestinal Microbiome (Focus) and Gastrointestinal Symptoms, run by Chr Hansen - part of Novonesis at 1 site in Ireland.
Trial summary
The study is a single-center, randomized, double-blind, placebo-controlled study in middle-aged to elderly adults with excessive body weight. The study includes an 8-week intervention period followed by a 2-week follow-up period. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Microbiome (Focus), Gastrointestinal Symptoms
- What is being tested?
- Synbiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteIreland
- Study dates
- 18 Mar 2026to Dec 2026
- 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 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be able to give informed consent.
- Be between 50 to 70 years of age (inclusive).
- BMI ranging from 25.0 and 35.0 kg/m²
- Willing to maintain current level of physical activity and diet during the participation in the study.
- Experience ≤3 bowel movements per week within the month prior to screening
- Participants reported subclinical mild to moderate gastrointestinal complaints as defined by GSRS-IBS score 20-45 at screening.
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- Willing to consume the study product daily for the duration of the study.
- Willing to eat the same meal the evening before visiting site (visit 2 to visit 5).
- Participants are eligible for randomization if they fulfill the following two criteria based on the diary recordings during the run-in period prior to visit 2 9. Average GSRS-IBS composite symptom score between 20-45 during the two-week run-in period Record ≤6 bowel movements in the daily diary during the two-week run-in period
Who cannot join
- Has a history of drug and/or alcohol abuse.
- Has food allergies, or other issues with foods, that would preclude intake of the study products.
- Smoking, chewable tobacco and/or vaping and/or use of other nicotine products.
- Has any significant acute or chronic coexisting health conditions that would prevent them from fulfilling the study requirements, put the Participant at risk or would confound the interpretation of the study results as judged by the investigator on the basis of medical history and routine laboratory test results. Excluded health conditions include:
- diagnosis of GI disease (e.g. gastric or duodenal ulcers, inflammatory bowel disease, colon cancer) or irritable bowel syndrome (IBS)
- GI surgery that might have an effect on gastrointestinal tract function except cholecystectomy and appendectomy in the past 5 years or any major bowel resection at any time.
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- history of CVD
- uncontrolled hypertension
- Currently or recently taking a medication that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results. Prohibited medications include:
- systemic antimicrobial medication (including suppositories) within 4 weeks prior to visit 1
- OTC medications, for digestive symptoms such as PPIs, anti-spasmodics, laxatives, anti-diarrheic drugs within 2 weeks prior to visit 1
- 10. Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the study.
- 11. Participants may not be participating in other clinical studies. If the participant has previously taken part in an experimental study, the Investigator must ensure sufficient time has elapsed before entry to this study to ensure the integrity of the results.
- immunosuppressant drugs within the 4 weeks prior to the visit 1 d. systemic steroids within the 4 weeks prior to the visit 1 6. Regular oral non-steroidal anti-inflammatory (NSAIDs) within 1 week prior to visit 1 (topical NSAIDS allowed, Low-dose prophylactic aspirin use is acceptable if stable for 3 months prior to screening.) 7. Current or recent (in the past 4 weeks prior to visit 1) use of prohibited nutritional and non-nutritional supplements, that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results, including:
- Herbal supplements for digestive symptoms b. Large doses of vitamins and minerals, unless in stable dose c. Probiotic supplements d. Iron supplements 8. Current or recent (in the past 2-weeks) use of prohibited foods including yoghurts containing probiotics.
- 9. Planned major changes in lifestyle [i.e., diet (e.g. start of fibre-enriched diet), dieting, exercise level, travelling] during the duration of the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Emma Harrington contact
Ireland1 site, 1 recruiting
- Recruiting
Atlantia Clinical Trials Ltd
Cork, Blackpool, T23 R50R
Emma Harrington, +353 (0)21 430 7442, eharrington@atlantiatrials.com
About this study
Official title: The Effect of a Synbiotic on Intestinal Barrier Function and Microbiota Modulation in Middle-aged to Elderly Individuals With Excessive Body Weight: a Randomized, Double-blind, Placebo-controlled Study
The study is a single-center, randomized, double-blind, placebo-controlled study in middle-aged to elderly adults with excessive body weight. The study includes an 8-week intervention period followed by a 2-week follow-up period. The study will evaluate the effect of a synbiotic consisting of two probiotic strains and a prebiotic.
The aim is to investigate the effect of the synbiotic on modulating the gut microbiota and improving markers of gastrointestinal permeability and integrity and gastrointestinal discomfort.
- Being tested
- Synbiotic, Placebo
- Keywords
- Gastrointestinal Microbiome, Synbiotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SynbioticDietary supplement
Synbiotic
- Given daily for 56 days
PlaceboDietary supplement
Placebo
- Given daily for 56 days
| Study group | Role | What they receive |
|---|---|---|
| Synbiotic | Active comparator | Synbiotic dietary supplement Receives: Dietary Supplement: Synbiotic |
| Placebo | Placebo comparator | Identical looking placebo consisting of maltodextrin Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bifidobacterium abundance
Change in total relative abundance of Bifidobacterium from baseline to 8 weeks assessed from fecal samples. Abundance is calculated based on shotgun metagenomic sequencing.
Measured: From baseline to end of intervention at 8 weeks
Secondary outcomes (11)
Stool frequency
Change in number of daily bowel movements from 2 weeks average prior to baseline to 2 weeks average prior to end of intervention. An increase is desirable.
Measured: From baseline to end of intervention at 8 weeks
Fecal acetate
Change in fecal acetate as measured by targeted metabolomics (GC-MSMS) from baseline to 8 weeks.
Measured: From baseline to end of intervention at 8 weeks.
Fecal propionate
Change in fecal propionate as measured by targeted metabolomics (GC-MSMS) from baseline to 8 weeks.
Measured: From baseline to end of intervention at 8 weeks.
Fecal butyrate
Change in fecal butyrate as measured by targeted metabolomics (GC-MSMS) from baseline to 8 weeks.
Measured: From baseline to end of intervention at 8 weeks
Zonulin
Change in serum zonulin from baseline to 8 weeks
Measured: From baseline to end of intervention at 8 weeks
Lipopolysaccharide binding protein (LPS-BP)
Change in plasma LPS-BP from baseline to 8 weeks
Measured: From baseline to end of intervention at 8 weeks
Interleukin 6 (IL-6)
Change in serum IL-6 from baseline to 8 weeks
Measured: From baseline to end of intervention at 8 weeks
High-sensitivity C-Reactive Protein (hsCRP)
Change in serum hsCRP from baseline to 8 weeks.
Measured: From baseline to end of intervention at 8 weeks
Fecal Short-Chain Fatty Acids (SCFA)
Change in composite measurement of fecal SCFAs panel with targeted metabolomics (GC-MSMS) from baseline to 8 weeks. Total composite is defined as: acetate + propionate + butyrate.
Measured: From baseline to end of intervention at 8 weeks
Stool consistency
Change in mean stool consistency assessed daily from 2 weeks prior to baseline to daily 2 weeks prior to end-of intervention. Stool consistency will be assessed by Bristol stool chart scale rated Type 1 (separate hard lumps) to Type 7 (watery, no solid pieces). An increase in stool consistency is desirable.
Measured: From baseline to end of intervention at 8 weeks
Gastrointestinal Symptom Rating Scale for Irritable Bowel Syndrome (GSRS-IBS) score
Change in GSRS-IBS composite score from baseline to end-of-intervention visit. The GSRS-IBS questionnaire includes 13 items that measure the severity of IBS symptoms in five clusters (pain, bloating, constipation, diarrhea and early satiety) during the last seven days. A decrease is desirable.
Measured: From baseline to end of intervention at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start18 Mar 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal Microbiome (Focus)Studies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized, double-blind, placebo-controlled trial of 8-week intervention and a 2-week follow-up period in a group of middle-aged to elderly adults with GI discomfort
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chr Hansen - part of Novonesis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Timothy G Dinan, Professor, Principal investigator, Atlantia Clinical Trials Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07453823
- Sponsor's protocol ID
- HHB-GI-2406
- Other IDs
- ECM4(i)11/12/2025
- Acronym
- myBIOM
- Status last verified
- Apr 2026
- First submitted
- 24 Feb 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Synbiotic on Intestinal Barrier Function and Microbiota Modulation in Middle-aged to Elderly Individuals With Excessive Body Weight: a Randomized, Double-blind, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT07453823
- Acronym / sponsor ID
- myBIOM / HHB-GI-2406
- Keywords
- Gastrointestinal Microbiome, Synbiotic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Chr Hansen - part of NovonesisIndustry (pharma, biotech, devices)
- Study start
- 18 Mar 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 6 Mar 2026 (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.
The study is a single-center, randomized, double-blind, placebo-controlled study in middle-aged to elderly adults with excessive body weight. The study includes an 8-week intervention period followed by a 2-week follow-up period. The study will evaluate the effect of a synbiotic consisting of two probiotic strains and a prebiotic.
The aim is to investigate the effect of the synbiotic on modulating the gut microbiota and improving markers of gastrointestinal permeability and integrity and gastrointestinal discomfort.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized, double-blind, placebo-controlled trial of 8-week intervention and a 2-week follow-up period in a group of middle-aged to elderly adults with GI discomfort
| Arm | Type | Receives |
|---|---|---|
| Synbiotic | Active comparator | Dietary Supplement: SynbioticSynbiotic dietary supplement |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboIdentical looking placebo consisting of maltodextrin |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Be able to give informed consent.
- Be between 50 to 70 years of age (inclusive).
- BMI ranging from 25.0 and 35.0 kg/m²
- Willing to maintain current level of physical activity and diet during the participation in the study.
- Experience ≤3 bowel movements per week within the month prior to screening
Key exclusion criteria (16 listed)
- Has a history of drug and/or alcohol abuse.
- Has food allergies, or other issues with foods, that would preclude intake of the study products.
- Smoking, chewable tobacco and/or vaping and/or use of other nicotine products.
- Has any significant acute or chronic coexisting health conditions that would prevent them from fulfilling the study requirements, put the Participant at risk or would confound the interpretation of the study results as judged by the investigator on the basis of medical history and routine laboratory test results. Excluded health conditions include:
- Currently or recently taking a medication that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results. Prohibited medications include:
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 |
|---|---|---|
| SynbioticSynbiotic - Given daily for 56 days | Dietary supplement | Synbiotic |
| PlaceboPlacebo - Given daily for 56 days | Dietary supplement | Placebo |
Primary outcome
Bifidobacterium abundance
Time frame: From baseline to end of intervention at 8 weeks
Change in total relative abundance of Bifidobacterium from baseline to 8 weeks assessed from fecal samples. Abundance is calculated based on shotgun metagenomic sequencing.
11 secondary outcomes
Stool frequency
Time frame: From baseline to end of intervention at 8 weeks
Fecal acetate
Time frame: From baseline to end of intervention at 8 weeks.
Fecal propionate
Time frame: From baseline to end of intervention at 8 weeks.
Fecal butyrate
Time frame: From baseline to end of intervention at 8 weeks
Zonulin
Time frame: From baseline to end of intervention at 8 weeks
Lipopolysaccharide binding protein (LPS-BP)
Time frame: From baseline to end of intervention at 8 weeks
Interleukin 6 (IL-6)
Time frame: From baseline to end of intervention at 8 weeks
High-sensitivity C-Reactive Protein (hsCRP)
Time frame: From baseline to end of intervention at 8 weeks
Fecal Short-Chain Fatty Acids (SCFA)
Time frame: From baseline to end of intervention at 8 weeks
Stool consistency
Time frame: From baseline to end of intervention at 8 weeks
Gastrointestinal Symptom Rating Scale for Irritable Bowel Syndrome (GSRS-IBS) score
Time frame: From baseline to end of intervention at 8 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 15 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Emma Harrington contact
Timothy G Dinan, Professor principal investigator
Atlantia Clinical Trials Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Synbiotic in people with Gastrointestinal Microbiome (Focus) and Gastrointestinal Symptoms, run by Chr Hansen - part of Novonesis at 1 site in Ireland.
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 9 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 15 Apr 2026. 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 Ireland. 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?
Contact Sara Engel, PhD (+45 45 74 74 74, saen@novonesis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bifidobacterium abundance (time frame: From baseline to end of intervention at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Apr 2026.