Healthy VolunteersPhase 4CRIBNCT02018900
The Effects of the Synbiotic Ecologic 825/scFOS on Intestinal Barrier Function and Immune Modulation
A Phase 4 study testing Ecologic 825/scFOS in people with Healthy Volunteers, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
In the present pilot study, the investigators will study the effects of a novel synbiotic, which is a mix of probiotics (Ecologic 825) in the presence of a prebiotic (short chain fructo-oligosaccharide (scFOS)), on mucosal integrity, overall microbiota changes along the gastrointestinal-tract and the mucosal immune… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Ecologic 825/scFOS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2013to May 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Based on medical history and previous self-admitted examination, no gastrointestinal complaints can be defined
- Age between 18 and 65 years
- Body Mass Index (BMI) between 20 and 30 kilogram/m2
Who cannot join
- History of severe cardiovascular, respiratory, urogenital, gastrointestinal/ hepatic, hematological/immunologic, head, ears, eyes, nose, throat (HEENT), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological diseases, allergy, major surgery and/or laboratory assessments which might limit participation in or completion of the study protocol. - Use of medication, including vitamin supplementation, except oral contraceptives, within 14 days prior to testing
- Administration of probiotic supplements, investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator), in the 180 days prior to the study
- Use of antibiotics in the 90 days prior to the study
- Abdominal surgery interfering with gastrointestinal function, upon judgment of the principle investigator)
- Pregnancy, lactation
- Excessive alcohol consumption (>20 alcoholic consumptions per week)
Show all 10Show fewer
- Smoking
- Blood donation within 3 months before or after the study period
- Self-admitted Human immunodeficiency virus-positive state
- History of any side effects towards intake of pro- or prebiotic supplements of any kind
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Center
Maastricht, Limburg, 6229 HX
About this study
Official title: The Effects of the Synbiotic Ecologic 825/scFOS on Intestinal Barrier Function
In the present pilot study, the investigators will study the effects of a novel synbiotic, which is a mix of probiotics (Ecologic 825) in the presence of a prebiotic (short chain fructo-oligosaccharide (scFOS)), on mucosal integrity, overall microbiota changes along the gastrointestinal-tract and the mucosal immune response. The investigators hypothesize that the synbiotic Ecologic 825/scFOS will significantly affect the intestinal permeability and modulate the immune system in humans.
- Conditions
- Healthy Volunteers
- Being tested
- Ecologic 825/scFOS, Placebo
- Keywords
- Synbiotics, Intestinal permeability, Microbiota, Immune response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ecologic 825/scFOSDietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Receives: Dietary Supplement: Placebo |
| Ecologic 825/scFOS | Experimental | Ecologic 825/scFOS Receives: Dietary Supplement: Ecologic 825/scFOS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sugar recovery in urine, as indicator of intestinal permeability
Measured: Baseline and after 2 weeks intervention
Secondary outcomes (6)
Biomarkers of immune modulation; plasma levels of Tumor necrosis factor alpha , Interleukin-1 beta, Interleukin-6, Interleukin-8, Interleukin-17, Monocyte chemoattractant protein-1 and Macrophage inflammatory protein-1a
Measured: Baseline and after 2 weeks intervention
Relative abundance of commensal rat ileum bacterium (CRIB) by quantitative polymerase chain reaction (qPCR)
Measured: Baseline and after 2 weeks intervention
Barcoded pyrosequencing of 16S rRNA genes of the microbiota
Measured: Baseline and after 2 weeks intervention
Metatranscriptomics of the microbiota
Measured: Baseline and after 2 weeks intervention
10 item gastrointestinal symptom diary
Measured: Baseline and after 2 weeks intervention
Quantitative Insights Into Microbial Ecology (QIIME) of the microbiota
Measured: Baseline and after 2 weeks intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- A.A.M. Masclee, Professor, Principal investigator, Department of Internal Medicine, Division of Gastroenterology-Hepatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02018900
- Sponsor's protocol ID
- 13-3-016
- Acronym
- CRIB
- Status last verified
- Dec 2014
- First submitted
- 9 Dec 2013
- Last updated
- 23 Dec 2014
- Results posted
- No
Publications
An R, Wilms E, Gerritsen J, Kim HK, Perez CS, Besseling-van der Vaart I, Jonkers DMAE, Rijkers GT, de Vos WM, Masclee AAM, Zoetendal EG, Troost FJ, Smidt H. Spatio-temporal dynamics of the human small intestinal microbiome and its response to a synbiotic. Gut Microbes. 2024 Jan-Dec;16(1):2350173. doi: 10.1080/19490976.2024.2350173. Epub 2024 May 13.
PubMed 38738780
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of the Synbiotic Ecologic 825/scFOS on Intestinal Barrier Function
- ClinicalTrials.gov ID
- NCT02018900
- Acronym / sponsor ID
- CRIB / 13-3-016
- Conditions
- Healthy Volunteers
- Keywords
- Synbiotics, Intestinal permeability, Microbiota, Immune response
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 23 Dec 2013 (estimated)
- 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.
In the present pilot study, the investigators will study the effects of a novel synbiotic, which is a mix of probiotics (Ecologic 825) in the presence of a prebiotic (short chain fructo-oligosaccharide (scFOS)), on mucosal integrity, overall microbiota changes along the gastrointestinal-tract and the mucosal immune response. The investigators hypothesize that the synbiotic Ecologic 825/scFOS will significantly affect the intestinal permeability and modulate the immune system in humans.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo |
| Ecologic 825/scFOS | Experimental | Dietary Supplement: Ecologic 825/scFOSEcologic 825/scFOS |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Based on medical history and previous self-admitted examination, no gastrointestinal complaints can be defined
- Age between 18 and 65 years
- Body Mass Index (BMI) between 20 and 30 kilogram/m2
Key exclusion criteria (10 listed)
- History of severe cardiovascular, respiratory, urogenital, gastrointestinal/ hepatic, hematological/immunologic, head, ears, eyes, nose, throat (HEENT), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological diseases, allergy, major surgery and/or laboratory assessments which might limit participation in or completion of the study protocol. - Use of medication, including vitamin supplementation, except oral contraceptives, within 14 days prior to testing
- Administration of probiotic supplements, investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator), in the 180 days prior to the study
- Use of antibiotics in the 90 days prior to the study
- Abdominal surgery interfering with gastrointestinal function, upon judgment of the principle investigator)
- Pregnancy, lactation
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 |
|---|---|---|
| Ecologic 825/scFOS | Dietary supplement | Ecologic 825/scFOS |
| Placebo | Dietary supplement | Placebo |
Primary outcome
Sugar recovery in urine, as indicator of intestinal permeability
Time frame: Baseline and after 2 weeks intervention
6 secondary outcomes
Biomarkers of immune modulation; plasma levels of Tumor necrosis factor alpha , Interleukin-1 beta, Interleukin-6, Interleukin-8, Interleukin-17, Monocyte chemoattractant protein-1 and Macrophage inflammatory protein-1a
Time frame: Baseline and after 2 weeks intervention
Relative abundance of commensal rat ileum bacterium (CRIB) by quantitative polymerase chain reaction (qPCR)
Time frame: Baseline and after 2 weeks intervention
Barcoded pyrosequencing of 16S rRNA genes of the microbiota
Time frame: Baseline and after 2 weeks intervention
Metatranscriptomics of the microbiota
Time frame: Baseline and after 2 weeks intervention
10 item gastrointestinal symptom diary
Time frame: Baseline and after 2 weeks intervention
Quantitative Insights Into Microbial Ecology (QIIME) of the microbiota
Time frame: Baseline and after 2 weeks intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2014.
- Derived from this study: PubMed 38738780An R, Wilms E, Gerritsen J, Kim HK, Perez CS, Besseling-van der Vaart I, Jonkers DMAE, Rijkers GT, de Vos WM, Masclee AAM, Zoetendal EG, Troost FJ, Smidt H. Spatio-temporal dynamics of the human small intestinal microbiome and its response to a synbiotic. Gut Microbes. 2024 Jan-Dec;16(1):2350173. doi: 10.1080/19490976.2024.2350173. Epub 2024 May 13.
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Screening Protocol
Pain
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.
A.A.M. Masclee, Professor principal investigator
Department of Internal Medicine, Division of Gastroenterology-Hepatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ecologic 825/scFOS in people with Healthy Volunteers, run by Maastricht University Medical Center at 1 site in Netherlands.
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 3 inclusion and 10 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: finished, as of the sponsor's last update on 23 Dec 2014. 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 Netherlands. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sugar recovery in urine, as indicator of intestinal permeability (time frame: Baseline and after 2 weeks intervention). 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 NCT02018900, which also lists 1 linked publication.
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 23 Dec 2014.