Ileostomy - StomaINSIDENCT02920294
Modulation of Microbial Composition in Ileostomy Patients
A study testing Probiotic 1 and Probiotic 2 in people with Ileostomy - Stoma, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
To determine the small intestinal microbiota response in humans to dietary interventions for two consecutive weeks, and to relate this to parameters of intestinal barrier function and immune and metabolic responses in blood, as functional outcome parameters of host physiology Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ileostomy - Stoma
- What is being tested?
- Probiotic 1 and Probiotic 2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2016to 11 Nov 2017
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Ileostomy installed at least 3 years prior to participation
- Free of any complications originating from the colectomy procedure for at least 1 yr prior to participation, with the exception of possible skin irritation at the location of the stoma
- BMI from 18 till 28 kg/m2
- Age from 18 till 70 years
- Available for entire study protocol.
- For female: If of child bearing potential, female subjects must be using or complying with methods of contraception (such as oral birth control pills, intra-uterine device, double barrier methods (like condoms and spermicide, etc.)
Who cannot join
- • History of cardiovascular, respiratory, urogenital, hepatic, haematological / immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological diseases, allergy, laboratory assessments which might limit participation in or completion of the study protocol, and/or major surgery with the exception of total colectomy, hysterectomy and/or appendectomy.
- Subject with known lactose intolerance or with known or suspected allergy or hypersensitivity to any component of the study product(s) (milk protein for example) + sucrose + rhamnose
- Severe gastrointestinal symptoms. In case of mild gastrointestinal symptoms, the principal investigator and the medically responsible MD will judge eligibility to participate.
- Removal of more than 15 cm of the ileum during or at any moment after the colectomy procedure
- Abdominal surgery interfering with gastrointestinal function, upon judgment of the principal investigator and the medically responsible MD
- Use of medication, including proton pump inhibitors, non-steroidal anti-inflammatory drugs interfering with endpoints (but except oral contraceptives), within 14 days prior to and during participation.
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- Consumption of any probiotic or prebiotic supplements or pre- and probiotics containing food products, investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principal investigator), in the 4 weeks prior to the study and during study participation (E4 PreProbiotics).
- Use of antibiotics in the 4 weeks prior to the start of study and during study participation
- Prohibited use of pro-, pre- or synbiotics during study period and three months prior to start of study. A list with forbidden products will be provided'
- 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 Centre
Maastricht, Limburg, 6229 HX
About this study
Official title: Modulation of Small Intestinal Microbial Composition and Activity,Systemic Immune Adaptation and Blood Transcriptional Changes Induced by 2-wks Consumption With 2 Fermented Milk Products;a Randomized,Exploratory,Cross-over,Double Blind,Controlled Study in Ileostomy Patients
To determine the small intestinal microbiota response in humans to dietary interventions for two consecutive weeks, and to relate this to parameters of intestinal barrier function and immune and metabolic responses in blood, as functional outcome parameters of host physiology
- Conditions
- Ileostomy - Stoma
- Being tested
- Probiotic 1, Probiotic 2, Placebo
- Keywords
- probiotics, microbiota, ileostoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic 1Dietary supplement
Fresh fermented dairy drink containing yoghurt ferments
Probiotic 2Dietary supplement
Fresh fermented dairy drink containing probiotic strain
PlaceboDietary supplement
Acidified dairy drink without ferments
| Study group | Role | What they receive |
|---|---|---|
| Probiotic 1 | Active comparator | Fresh fermented dairy drink containing yoghurt ferments consumed as follows: one bottle (100g) OD for 14 consecutive days Receives: Dietary Supplement: Probiotic 1 |
| Probiotic 2 | Active comparator | Fresh fermented dairy drink containing probiotic strain consumed as follows: one bottle (100g) OD for 14 consecutive days Receives: Dietary Supplement: Probiotic 2 |
| Placebo | Placebo comparator | Acidified dairy drink without ferments consumed as follows: one bottle (100g) OD for 14 consecutive days Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Temporal microbial composition and activity in the small intestine in ileal effluent
The microbiome activity will be determined as a function of the diet by double strand cDNA production and random sequencing of mRNA enriched fractions of total effluent RNA obtained from the effluent samples at the start and end of each intervention period.
Measured: 2 weeks intervention
Secondary outcomes (10)
Small intestinal permeability by a multi sugar test (urinary recovery of test sugars)
Measured: 2 weeks intervention
Gene transcription response in blood by transcriptome patterns.
Transcriptome patterns will be determined in peripheral blood mononuclear cells obtained from blood samples from the participating ileostoma patients
Measured: 2 weeks intervention
The levels of a panel of peripheral blood biomarkers related to immune, metabolic and hormonal status
A panel of biomarkers will be determined in peripheral blood obtained at the start and end of the intervention periods
Measured: 2 weeks intervention
The level of whole blood immune responsiveness to a panel of standardized stimuli ex vivo
Peripheral whole blood immune responsiveness towards a subset of bacterial immune-stimuli will be assessed using the standardized truculture system
Measured: 2 weeks intervention
Morning urine metabolome profiles
The principal analytical methodology employed is mass-spectrometry profiling and can commonly provide reliable quantifications of more than 400 named-metabolites in different body-fluid samples.
Measured: 2 weeks intervention
Peripheral blood metabolome profiles
The principal analytical methodology employed is mass-spectrometry profiling and can commonly provide reliable quantifications of more than 400 named-metabolites in different body-fluid samples.
Measured: 2 weeks intervention
The relative survival of bacterial strains (colony forming unit enumeration on semi-selective culture plates)
Measured: 2 weeks intervention
Short chain fatty acid profiles in ileal effluent
Measured: 2 weeks intervention
Number of participants with Gastrointestinal symptoms by Visual Analogue Scales
Measured: 2 weeks intervention
Occurrence and severity of treatment related adverse events
Measured: 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 posted30 Sep 2016 (estimated)
- Study startSep 2016
- Primary completion11 Nov 2017
- Study completion11 Nov 2017
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 Ileostomy - StomaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fred Troost, PhD, Principal investigator, Maastricht University Medical Center (MUMC+)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02920294
- Sponsor's protocol ID
- METC 163023
- Acronym
- INSIDE
- Status last verified
- Jul 2018
- First submitted
- 27 Sep 2016
- Last updated
- 2 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Zaccaria E, Klaassen T, Alleleyn AME, Boekhorst J, Smokvina T, Kleerebezem M, Troost FJ. Endogenous small intestinal microbiome determinants of transient colonisation efficiency by bacteria from fermented dairy products: a randomised controlled trial. Microbiome. 2023 Mar 7;11(1):43. doi: 10.1186/s40168-023-01491-4.
PubMed 36879297
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of Small Intestinal Microbial Composition and Activity,Systemic Immune Adaptation and Blood Transcriptional Changes Induced by 2-wks Consumption With 2 Fermented Milk Products;a Randomized,Exploratory,Cross-over,Double Blind,Controlled Study in Ileostomy Patients
- ClinicalTrials.gov ID
- NCT02920294
- Acronym / sponsor ID
- INSIDE / METC 163023
- Conditions
- Ileostomy - Stoma
- Keywords
- probiotics, microbiota, ileostoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- 11 Nov 2017 (actual)
- Study completion
- 11 Nov 2017 (actual)
- First posted
- 30 Sep 2016 (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.
To determine the small intestinal microbiota response in humans to dietary interventions for two consecutive weeks, and to relate this to parameters of intestinal barrier function and immune and metabolic responses in blood, as functional outcome parameters of host physiology
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Probiotic 1 | Active comparator | Dietary Supplement: Probiotic 1Fresh fermented dairy drink containing yoghurt ferments consumed as follows: one bottle (100g) OD for 14 consecutive days |
| Probiotic 2 | Active comparator | Dietary Supplement: Probiotic 2Fresh fermented dairy drink containing probiotic strain consumed as follows: one bottle (100g) OD for 14 consecutive days |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboAcidified dairy drink without ferments consumed as follows: one bottle (100g) OD for 14 consecutive days |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- • Ileostomy installed at least 3 years prior to participation
Key exclusion criteria (10 listed)
- • History of cardiovascular, respiratory, urogenital, hepatic, haematological / immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological diseases, allergy, laboratory assessments which might limit participation in or completion of the study protocol, and/or major surgery with the exception of total colectomy, hysterectomy and/or appendectomy.
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 |
|---|---|---|
| Probiotic 1Fresh fermented dairy drink containing yoghurt ferments | Dietary supplement | Probiotic 1 |
| Probiotic 2Fresh fermented dairy drink containing probiotic strain | Dietary supplement | Probiotic 2 |
| PlaceboAcidified dairy drink without ferments | Dietary supplement | Placebo |
Primary outcome
Temporal microbial composition and activity in the small intestine in ileal effluent
Time frame: 2 weeks intervention
The microbiome activity will be determined as a function of the diet by double strand cDNA production and random sequencing of mRNA enriched fractions of total effluent RNA obtained from the effluent samples at the start and end of each intervention period.
10 secondary outcomes
Small intestinal permeability by a multi sugar test (urinary recovery of test sugars)
Time frame: 2 weeks intervention
Gene transcription response in blood by transcriptome patterns.
Time frame: 2 weeks intervention
The levels of a panel of peripheral blood biomarkers related to immune, metabolic and hormonal status
Time frame: 2 weeks intervention
The level of whole blood immune responsiveness to a panel of standardized stimuli ex vivo
Time frame: 2 weeks intervention
Morning urine metabolome profiles
Time frame: 2 weeks intervention
Peripheral blood metabolome profiles
Time frame: 2 weeks intervention
The relative survival of bacterial strains (colony forming unit enumeration on semi-selective culture plates)
Time frame: 2 weeks intervention
Short chain fatty acid profiles in ileal effluent
Time frame: 2 weeks intervention
Number of participants with Gastrointestinal symptoms by Visual Analogue Scales
Time frame: 2 weeks intervention
Occurrence and severity of treatment related adverse events
Time frame: 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 2 Aug 2018.
- Derived from this study: PubMed 36879297Zaccaria E, Klaassen T, Alleleyn AME, Boekhorst J, Smokvina T, Kleerebezem M, Troost FJ. Endogenous small intestinal microbiome determinants of transient colonisation efficiency by bacteria from fermented dairy products: a randomised controlled trial. Microbiome. 2023 Mar 7;11(1):43. doi: 10.1186/s40168-023-01491-4.
- Individual participant dataSharing planned: Yes
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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. This study is not recruiting at the moment.
Fred Troost, PhD principal investigator
Maastricht University Medical Center (MUMC+)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic 1 and Probiotic 2 in people with Ileostomy - Stoma, 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 6 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 2 Aug 2018. 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.
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?
Temporal microbial composition and activity in the small intestine in ileal effluent (time frame: 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 NCT02920294, 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 2 Aug 2018.