Changes in Gut Microbiota Bifidobacterial LevelsBISONNCT06645171
Effect of an Oral Nutritional Supplement (ONS) with Prebiotic Fibre Compared to a Non-fibre Containing ONS Equal in Energy and Protein Content on Gut Microbiota in Older Adults with or At Risk of Disease Related Malnutrition
A study testing Fibre drink in people with Changes in Gut Microbiota Bifidobacterial Levels, run by Nutricia Research.
Trial summary
This study assesses the effects of an oral nutritional supplement (ONS) with fibre compared to a non-fibre containing ONS equal in energy and protein content on gut microbiota bifidobacteria in older adults with or at risk of disease related malnutrition. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Changes in Gut Microbiota Bifidobacterial Levels
- What is being tested?
- Fibre drink
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- Nov 2024to 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 1. 65 years of age or older 2. Identified as at medium or high risk of malnutrition based on:
- MNA-SF score between 0 - 11 and / or b) are prescribed with ONS 3. In need of 2 servings of oral nutritional support/day (300 kcal; 12 gr protein per serving).
- 4. a) Not being prescribed with ONS or b) being prescribed with non-fibre containing ONS and willing and able to switch from pre-study prescribed ONS to the Test or Control Product for participation in the study.
- 5. Willing to maintain dietary habits for the duration of the study. Written informed consent from subject (or impartial witness after verbal consent of subject when subject is physically unable to sign and where allowed by local regulations).
Who cannot join
- 1. Requirement for a fibre-free diet. 2. Have used nutritional supplements with fibre/prebiotics and/or probiotics content at any point during 3 weeks prior to start study (Visit 1) and / or will not refrain from using these kinds of products during the study period.
- 3. Admitted to an intensive care unit. 4. Hemodynamically unstable. 5. Known allergy to cow's milk protein. 6. Known galactosaemia. 7. Known hepatic encephalopathy. 8. Known Irritable Bowel Syndrome. 9. Known severe lactose intolerance without using lactase. 10. Known history of GI surgery. 11. Known history of intestinal polyp removal within 3 months prior to the study.
- 12. Known history of Immunotherapy. 13. Known history of GI cancer. 14. Active cancer treatment or within 12 months prior the study 15. Diagnose of Celiac Disease. 16. Received antibiotics within 4 weeks prior to study. 17. Patients following a vegan or vegetarian diet. 18. Active flare of inflammatory bowel disease as defined by HBI >6 (Crohn's disease) or SCCAI >5 (ulcerative colitis).
- 19. Stricturing Crohn's disease. 20. Any contraindication to oral feeding per se being: gastrointestinal failure or suppressed gastrointestinal function, complete intestinal obstruction and major intra-abdominal sepsis.
- 21. Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements, for example due to the presence of a psychiatric disorder (e.g. major depression, psychoses), dementia or Alzheimer's disease.
- 22. Planned hospital admission during the study period in case not hospitalised at screening 23. Participation in any other studies involving investigational or marketed products concomitantly or within 6 weeks prior to baseline.
- 24. Severe disease with life expectancy less than a year.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Danone Global Research & Innovation Center contact
About this study
Official title: Effect of an Oral Nutritional Supplement (ONS) with Prebiotic Fibre Compared to a Non-fibre Containing ONS Equal in Energy and Protein Content on Gut Microbiota Bifidobacteria in Older Adults with or At Risk of Disease Related Malnutrition
This study assesses the effects of an oral nutritional supplement (ONS) with fibre compared to a non-fibre containing ONS equal in energy and protein content on gut microbiota bifidobacteria in older adults with or at risk of disease related malnutrition. It is a randomised controlled, double blind, parallel-group, multi-country study. Subjects will receive an ONS with or without (control group) fibre. They take it twice a day for 4 weeks and the change in their gut microbiota bifidobacterial levels is the primary outcome. They will be measured at day 1 (V1), day 15 (V2) and week 4 (V3).
- Being tested
- Fibre drink
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibre drinkDietary supplement
One drink will be tested
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | ONS including fibre (300 kcal, 12gr protein, 125 mL, 4.5 g fibre), The subjects will use study products twice daily for 4 weeks starting at V1. Receives: Dietary Supplement: Fibre drink |
| Arm 2 | Experimental | ONS without fibre (300 kcal, 12gr protein, 125 mL, 0 g fibre), The subjects will use control products twice daily for 4 weeks starting at V1. Receives: Dietary Supplement: Fibre drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in gut microbiota bifidobacterial levels
Measured: 4 weeks
Secondary outcomes (4)
Changes in gut microbiota composition
Measured: 4 weeks
Fecal pH
Measured: 4 weeks
Stool frequency and consistency assessed by the Bristol Stool Form Scale (BSFS)
Measured: 4 weeks
Total short-chain fatty acids (SCFA)
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 posted16 Oct 2024
- Study startNov 2024 (estimated)
- 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 Changes in Gut Microbiota Bifidobacterial LevelsStudies of the same condition, open and under way.
- More trials run by Nutricia ResearchThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nutricia Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06645171
- Sponsor's protocol ID
- 23REX0060367
- Acronym
- BISON
- Status last verified
- Oct 2024
- First submitted
- 10 Oct 2024
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Oral Nutritional Supplement (ONS) with Prebiotic Fibre Compared to a Non-fibre Containing ONS Equal in Energy and Protein Content on Gut Microbiota Bifidobacteria in Older Adults with or At Risk of Disease Related Malnutrition
- ClinicalTrials.gov ID
- NCT06645171
- Acronym / sponsor ID
- BISON / 23REX0060367
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Nutricia ResearchIndustry (pharma, biotech, devices)
- Study start
- Nov 2024 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 16 Oct 2024 (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.
This study assesses the effects of an oral nutritional supplement (ONS) with fibre compared to a non-fibre containing ONS equal in energy and protein content on gut microbiota bifidobacteria in older adults with or at risk of disease related malnutrition. It is a randomised controlled, double blind, parallel-group, multi-country study. Subjects will receive an ONS with or without (control group) fibre. They take it twice a day for 4 weeks and the change in their gut microbiota bifidobacterial levels is the primary outcome. They will be measured at day 1 (V1), day 15 (V2) and week 4 (V3).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Dietary Supplement: Fibre drinkONS including fibre (300 kcal, 12gr protein, 125 mL, 4.5 g fibre), The subjects will use study products twice daily for 4 weeks starting at V1. |
| Arm 2 | Experimental | Dietary Supplement: Fibre drinkONS without fibre (300 kcal, 12gr protein, 125 mL, 0 g fibre), The subjects will use control products twice daily for 4 weeks starting at V1. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 1. 65 years of age or older 2. Identified as at medium or high risk of malnutrition based on:
- 4. a) Not being prescribed with ONS or b) being prescribed with non-fibre containing ONS and willing and able to switch from pre-study prescribed ONS to the Test or Control Product for participation in the study.
- 5. Willing to maintain dietary habits for the duration of the study. Written informed consent from subject (or impartial witness after verbal consent of subject when subject is physically unable to sign and where allowed by local regulations).
Key exclusion criteria (7 listed)
- 1. Requirement for a fibre-free diet. 2. Have used nutritional supplements with fibre/prebiotics and/or probiotics content at any point during 3 weeks prior to start study (Visit 1) and / or will not refrain from using these kinds of products during the study period.
- 3. Admitted to an intensive care unit. 4. Hemodynamically unstable. 5. Known allergy to cow's milk protein. 6. Known galactosaemia. 7. Known hepatic encephalopathy. 8. Known Irritable Bowel Syndrome. 9. Known severe lactose intolerance without using lactase. 10. Known history of GI surgery. 11. Known history of intestinal polyp removal within 3 months prior to the study.
- 12. Known history of Immunotherapy. 13. Known history of GI cancer. 14. Active cancer treatment or within 12 months prior the study 15. Diagnose of Celiac Disease. 16. Received antibiotics within 4 weeks prior to study. 17. Patients following a vegan or vegetarian diet. 18. Active flare of inflammatory bowel disease as defined by HBI >6 (Crohn's disease) or SCCAI >5 (ulcerative colitis).
- 19. Stricturing Crohn's disease. 20. Any contraindication to oral feeding per se being: gastrointestinal failure or suppressed gastrointestinal function, complete intestinal obstruction and major intra-abdominal sepsis.
- 21. Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements, for example due to the presence of a psychiatric disorder (e.g. major depression, psychoses), dementia or Alzheimer's disease.
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 |
|---|---|---|
| Fibre drinkOne drink will be tested | Dietary supplement | Arm 1, Arm 2 |
Primary outcome
Changes in gut microbiota bifidobacterial levels
Time frame: 4 weeks
4 secondary outcomes
Changes in gut microbiota composition
Time frame: 4 weeks
Fecal pH
Time frame: 4 weeks
Stool frequency and consistency assessed by the Bristol Stool Form Scale (BSFS)
Time frame: 4 weeks
Total short-chain fatty acids (SCFA)
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 16 Oct 2024.
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.
Danone Global Research & Innovation Center contact
Questions about this trial
What is this clinical trial studying?
A study testing Fibre drink in people with Changes in Gut Microbiota Bifidobacterial Levels, run by Nutricia Research.
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 4 inclusion and 7 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: opening soon, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 Danone Global Research & Innovation Center (+31 30 2095 000, register.clinicalresearchnutricia@danone.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in gut microbiota bifidobacterial levels (time frame: 4 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 16 Oct 2024.