InflammationNCT01534572
Significance of Synbiotics on Inflammation and Proliferation of Colonic Mucosa
A study testing Lactobacillus and Bifidobacterium in people with Inflammation, run by Region Skane.
Trial summary
There is a constant exchange between the gut epithelium and lumen, including microbial interplay. The aim of this study was to investigate dietary test products on inflammatory proliferation markers in the gut, and thereby if the products had positive effects in the gut as well as in other parts of the body. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammation
- What is being tested?
- Lactobacillus and Bifidobacterium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Jan 2006to Feb 2012
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-80 years old,
- Able to understand oral and written information,
- Informed consent
Who cannot join
- Ongoing immune suppressive treatment, incl. cortisone,
- Ongoing antibiotic treatment or antibiotic treatment ended within 4 weeks,
- History of inflammatory bowel disease
About this study
There is a constant exchange between the gut epithelium and lumen, including microbial interplay. The aim of this study was to investigate dietary test products on inflammatory proliferation markers in the gut, and thereby if the products had positive effects in the gut as well as in other parts of the body.
The hypothesis was that the test products would reduce the inflammatory and proliferation activity of the gut epithelium by fermentation of normal food products and by converting dietary phenolic compounds into anti-inflammatory substances.
- Conditions
- Inflammation
- Being tested
- Lactobacillus, Bifidobacterium
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LactobacillusDietary supplement
Also called Lactobacillus plantarum
Intervention (2 weeks) with a strain of Lactobacillus
BifidobacteriumDietary supplement
Also called Bifidobacterium infantis
Intervention (2 weeks) with a strain of Bifidobacterium
| Study group | Role | What they receive |
|---|---|---|
| Probiotics_Lactobacillus | Experimental | Intervention (2 weeks) with a strain of Lactobacillus Receives: Dietary Supplement: Lactobacillus |
| Probiotics_Bifidobacterium | Experimental | Intervention (2 weeks) of daily supplementation of a probiotic strain of Bifidobacterium. Receives: Dietary Supplement: Bifidobacterium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reactivity of rectal mucosa
to study the reactivity of rectal mucosa after a standardized inflammatory insult before and after treatment with probiotics
Measured: after 2 weeks intervention
Secondary outcomes (1)
influence on immune system
to study the influence on systemic leukocytes and regulatory T cells
Measured: 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 posted16 Feb 2012 (estimated)
- Study startJan 2006
- Primary completionMar 2006
- Study completionFeb 2012
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 InflammationStudies of the same condition, open and under way.
- More trials run by Region SkaneThe 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bengt Jeppson, MD, PhD, Study director, Region Skane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01534572
- Sponsor's protocol ID
- 538/2005
- Status last verified
- Feb 2012
- First submitted
- 13 Feb 2012
- Last updated
- 16 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Stene C, Rome A, Palmquist I, Linninge C, Molin G, Ahrne S, Johnson LB, Jeppsson B. Administration of probiotics to healthy volunteers: effects on reactivity of intestinal mucosa and systemic leukocytes. BMC Gastroenterol. 2022 Mar 5;22(1):100. doi: 10.1186/s12876-022-02185-1.
PubMed 35247974
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Significance of Synbiotics on Inflammation and Proliferation of Colonic Mucosa
- ClinicalTrials.gov ID
- NCT01534572
- Acronym / sponsor ID
- 538/2005
- Conditions
- Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Mar 2006 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 16 Feb 2012 (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.
There is a constant exchange between the gut epithelium and lumen, including microbial interplay. The aim of this study was to investigate dietary test products on inflammatory proliferation markers in the gut, and thereby if the products had positive effects in the gut as well as in other parts of the body.
The hypothesis was that the test products would reduce the inflammatory and proliferation activity of the gut epithelium by fermentation of normal food products and by converting dietary phenolic compounds into anti-inflammatory substances.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotics_Lactobacillus | Experimental | Dietary Supplement: LactobacillusIntervention (2 weeks) with a strain of Lactobacillus |
| Probiotics_Bifidobacterium | Experimental | Dietary Supplement: BifidobacteriumIntervention (2 weeks) of daily supplementation of a probiotic strain of Bifidobacterium. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-80 years old,
- Able to understand oral and written information,
- Informed consent
Key exclusion criteria (3 listed)
- Ongoing immune suppressive treatment, incl. cortisone,
- Ongoing antibiotic treatment or antibiotic treatment ended within 4 weeks,
- History of inflammatory bowel 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 |
|---|---|---|
| LactobacillusAlso: Lactobacillus plantarumIntervention (2 weeks) with a strain of Lactobacillus | Dietary supplement | Probiotics_Lactobacillus |
| BifidobacteriumAlso: Bifidobacterium infantisIntervention (2 weeks) with a strain of Bifidobacterium | Dietary supplement | Probiotics_Bifidobacterium |
Primary outcome
Reactivity of rectal mucosa
Time frame: after 2 weeks intervention
to study the reactivity of rectal mucosa after a standardized inflammatory insult before and after treatment with probiotics
1 secondary outcome
influence on immune system
Time frame: 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 16 Feb 2012.
- Derived from this study: PubMed 35247974Stene C, Rome A, Palmquist I, Linninge C, Molin G, Ahrne S, Johnson LB, Jeppsson B. Administration of probiotics to healthy volunteers: effects on reactivity of intestinal mucosa and systemic leukocytes. BMC Gastroenterol. 2022 Mar 5;22(1):100. doi: 10.1186/s12876-022-02185-1.
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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.
Bengt Jeppson, MD, PhD study director
Region Skane
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus and Bifidobacterium in people with Inflammation, run by Region Skane.
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 3 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 16 Feb 2012. 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?
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?
Reactivity of rectal mucosa (time frame: 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 NCT01534572, 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 16 Feb 2012.