HealthyNCT05461443
Lacticaseibacillus Rhamnosus GG Pili Study
A study testing Probiotic in people with Healthy, run by Örebro University, Sweden at 1 site in Sweden.
Trial summary
The aim of this study was to investigate the host-microbe interaction effects of various Lacticaseibacillus rhamnosus GG strains, with different binding capacities to the mucus in the small intestine, in healthy individuals Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Probiotic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSweden
- Study dates
- 31 Mar 2016to 30 Jun 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy males or females aged 18-65 years.
- Willing to abstain from any probiotics or medication known to alter gastrointestinal function during the study.
- A signed informed consent.
Who cannot join
- Recent or current treatment with drugs affecting intestinal function, immune function or mood (e.g. antidepressants). In addition use of all drugs during the study should be recorded.
- Recent (< 6 weeks) use of probiotics*.
- Diagnosis of major psychiatric or somatic disorders.
- Pregnancy or breastfeeding.
- Abuse of alcohol or drugs.
- Smokers and chewable tobacco users.
Show all 15Show fewer
- Lactose intolerance.
- Any kind of probiotics and with special attention on products containing LGG:
- Dairy products:
- Valio Kefir
- Valio Gefilus yoghurt
- Dietary supplements:
- Bifiform Daily
- Bifiform Travel
- Bifiform Daily Caps
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Modularity Immune Function of Lactobacillus Rhamnosus GG in the Small Intestine of Healthy Individuals
The aim of this study was to investigate the host-microbe interaction effects of various Lacticaseibacillus rhamnosus GG strains, with different binding capacities to the mucus in the small intestine, in healthy individuals
Read the detailed description
The project consisted in the supplementation of a) a wild-type LGG strain, b) a low-producing pili LGG strain or c) a high-producing pili LGG strain to study subjects. The individuals received the three treatment combinations in a randomised order. Each supplementation was given to the individuals every 30 min over a period of 6 hours. Eight biopsies from the duodenum were collected at the end of 6 h-solutions administration by flexible gastroduodenoscopy, likewise the routine procedure during this endoscopic investigation. Faecal samples were collected by the study subjects at home 1 day before, 2, 7 and 14 days days after administrations of each oral supplementation. The supplementations were separated by a 3-week wash-out period.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
Also called LGG
| Study group | Role | What they receive |
|---|---|---|
| Wild-type | Active comparator | Supplementation with the wild-type of the LGG strain Receives: Dietary Supplement: Probiotic |
| Low-pill | Experimental | Supplementation with the low-pili LGG strain Receives: Dietary Supplement: Probiotic |
| High-pili | Experimental | Supplementation with the high-pili LGG strain Receives: Dietary Supplement: Probiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in whole genome gene expression of duodenal mucosa after administration of three different LGG strain
Microarray-based Gene expression Analysis were carried out from duodenal biopsies collected after the supplementation of each LGG strain
Measured: 6hrs supplementation after start of LGG strain administration.
Microbiome of duodenal mucosal biopsies
Bacterial composition was analysed by Illumina MiSeq sequencing the hypervariable V3-V4 region of the 16S rRNA gene
Measured: 6hrs supplementation after start of LGG strain administration
Secondary outcomes (3)
Faecal microbiome
Bacterial composition by MiSeq sequencing hypervariable V3-V4 region of 16SrRNA gene
Measured: 2 days after LGG strain administration
Faecal microbiome
Bacterial composition by MiSeq sequencing hypervariable V3-V4 region of 16SrRNA gene
Measured: 7 days after LGG strain administration
Faecal microbiome
Bacterial composition by MiSeq sequencing hypervariable V3-V4 region of 16SrRNA gene
Measured: 14 days after LGG strain administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start31 Mar 2016
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The individuals did receive the three treatment combinations in a randomised order.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Örebro University, Sweden
- Sponsor type
- University, hospital or other
- Collaborators
- Valio Ltd, Chr Hansen
- Responsible party
- Principal investigator, Robert Brummer, Örebro University, Sweden
- Investigators
- Robert Brummer, Professor, Study director, Örebro University, School of Medical Sciences, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05461443
- Sponsor's protocol ID
- 2015/422
- Status last verified
- Jul 2022
- First submitted
- 8 Jul 2022
- Last updated
- 18 Jul 2022
- 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 18 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Modularity Immune Function of Lactobacillus Rhamnosus GG in the Small Intestine of Healthy Individuals
- ClinicalTrials.gov ID
- NCT05461443
- Acronym / sponsor ID
- 2015/422
- Conditions
- Healthy
- Keywords
- Lacticaseibacillus rhamnosus GG, Probiotics, Pili, Gut microbiota, Transcriptomics, Small intestine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Örebro University, SwedenUniversity, hospital or other
- Collaborators
- Valio Ltd, Chr Hansen
- Study start
- 31 Mar 2016 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 18 Jul 2022 (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 aim of this study was to investigate the host-microbe interaction effects of various Lacticaseibacillus rhamnosus GG strains, with different binding capacities to the mucus in the small intestine, in healthy individuals
Detailed description
The project consisted in the supplementation of a) a wild-type LGG strain, b) a low-producing pili LGG strain or c) a high-producing pili LGG strain to study subjects. The individuals received the three treatment combinations in a randomised order. Each supplementation was given to the individuals every 30 min over a period of 6 hours. Eight biopsies from the duodenum were collected at the end of 6 h-solutions administration by flexible gastroduodenoscopy, likewise the routine procedure during this endoscopic investigation. Faecal samples were collected by the study subjects at home 1 day before, 2, 7 and 14 days days after administrations of each oral supplementation. The supplementations were separated by a 3-week wash-out period.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- The individuals did receive the three treatment combinations in a randomised order.
| Arm | Type | Receives |
|---|---|---|
| Wild-type | Active comparator | Dietary Supplement: ProbioticSupplementation with the wild-type of the LGG strain |
| Low-pill | Experimental | Dietary Supplement: ProbioticSupplementation with the low-pili LGG strain |
| High-pili | Experimental | Dietary Supplement: ProbioticSupplementation with the high-pili LGG strain |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy males or females aged 18-65 years.
- Willing to abstain from any probiotics or medication known to alter gastrointestinal function during the study.
- A signed informed consent.
Key exclusion criteria (15 listed)
- Recent or current treatment with drugs affecting intestinal function, immune function or mood (e.g. antidepressants). In addition use of all drugs during the study should be recorded.
- Recent (< 6 weeks) use of probiotics*.
- Diagnosis of major psychiatric or somatic disorders.
- Pregnancy or breastfeeding.
- Abuse of alcohol or drugs.
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 |
|---|---|---|
| ProbioticAlso: LGG | Dietary supplement | High-pili, Low-pill, Wild-type |
Primary outcome
Difference in whole genome gene expression of duodenal mucosa after administration of three different LGG strain
Time frame: 6hrs supplementation after start of LGG strain administration.
Microarray-based Gene expression Analysis were carried out from duodenal biopsies collected after the supplementation of each LGG strain
Microbiome of duodenal mucosal biopsies
Time frame: 6hrs supplementation after start of LGG strain administration
Bacterial composition was analysed by Illumina MiSeq sequencing the hypervariable V3-V4 region of the 16S rRNA gene
3 secondary outcomes
Faecal microbiome
Time frame: 2 days after LGG strain administration
Faecal microbiome
Time frame: 7 days after LGG strain administration
Faecal microbiome
Time frame: 14 days after LGG strain administration
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 18 Jul 2022.
- Individual participant dataSharing planned: No
Related trials for Healthy
Not yet recruitingPhase 1
A Study of Phenytoin Mucoadhesive Film for Oral Ulcers in Healthy Volunteers
Oral Ulcer, Oral Mucositis
Not yet recruiting
SUVY VerSus SAccharose (SUVISA)
Healthy Volunteers, Erythritol
RecruitingPhase 1
A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 in Healthy Children
Seasonal Influenza
Not yet recruitingObservational study
Microneurographic Assessment of Peripheral Nerves in Healthy Volunteers and Individuals With Sensory Dysfunction Caused by Inherited Mutations in the PIEZO2 Gene
PIEZO2-Deficiency Syndrome
Enrolling by invitationObservational study
Connors Protocol for the Management and Use of Stored Human Specimens (Stored Human Specimens)
Healthy Volunteer Samples
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.
Robert Brummer, Professor study director
Örebro University, School of Medical Sciences, Sweden
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 in people with Healthy, run by Örebro University, Sweden at 1 site in Sweden.
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 15 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 18 Jul 2022. 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 Sweden. 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. 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?
Difference in whole genome gene expression of duodenal mucosa after administration of three different LGG strain (time frame: 6hrs supplementation after start of LGG strain administration.). The study lists 2 primary outcomes in all. 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 18 Jul 2022.