Microbiota Perturbation by an Environmental ChallengeNCT04424329
Effect of a Specific Blend of Fibers and Probiotics on the Microbiome
A study testing Fibers and probiotics in people with Microbiota Perturbation by an Environmental Challenge, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
Trial summary
The study will investigate the effect of a mix of fibers and probiotics on faecal microbiota challenged by an environmental stress Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Microbiota Perturbation by an Environmental Challenge
- What is being tested?
- Fibers and probiotics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 2 Jun 2020to 25 Sep 2020
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Informed consent signed
- Adult men and women aged 18 to 45 years
- Healthy based on the medical screening visit and medical questionnaire
- BMI in the range of 18.5 to 29.9 kg/m2.
Who cannot join
- Known food allergy and intolerance
- Currently participating in another clinical trial or research project
- Fewer than 5 spontaneous bowel movements per week on average
- Chronic or recurrent diarrhea with spontaneous bowel movements more often than 2 times daily
- Systemic antibacterial/antifungal therapy during the 3 months prior to study enrolment
- Medications or supplements that are known to alter gut function or microflora during the 4 weeks prior to study enrolment
Show all 12Show fewer
- Volunteers under anti-hyperlipidemic, antihypertensive, estrogen-related and/or anticoagulant agents
- Prior gastrointestinal surgery (apart from appendectomy, cholecystectomy or herniotomy)
- Alcohol intake higher than 2 servings per day. A serving is 0.4 dl of strong alcohols, 1 dl of red or white wine, or 3 dl of beer.
- Artificially sweetened beverage intake higher than 1000 ml/ per day
- Female subjects will be excluded if they are pregnant, gave birth in the last 6 months, or are lactating.
- Subject having a hierarchical or family link with the research team members.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Société des produits Nestlé/Metabolic Unit
Lausanne, 1000
About this study
The study will investigate the effect of a mix of fibers and probiotics on faecal microbiota challenged by an environmental stress
- Being tested
- Fibers and probiotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibers and probioticsDietary supplement
A blend of fibers and seven probiotics
| Study group | Role | What they receive |
|---|---|---|
| Nutrition intervention | Experimental | Ingestion of fibers and probiotics daily for 22 days Receives: Dietary Supplement: Fibers and probiotics |
| No intervention | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimizing microbiota composition change
Shotgum metagenomics
Measured: Daily from Day -4 to day + 7 (Day 0 is the start of the challenge)
Secondary outcomes (3)
Increased intestinal microbiota diversity
Measured by the Shannon diversity index
Measured: Daily from Day -4 to day + 7 (Day 0 is the start of the dietary challenge)
Increased microbiota gene richness
Measured by gene counts from metagenome sequencing of the fecal microbiota
Measured: Daily from Day -4 to day + 7 (Day 0 is the start of the dietary challenge)
Gut comfort
Assessed each Gastrointestinal Symptoms (VOMITING, NAUSEA, AUDIBLE BOWEL SOUNDS, FLATULENCE, ABDOMINAL CRAMPS, BLOATING ) with a scale (from 0 to 10, 10 being the worst outcome)
Measured: Daily from Day -10 to day + 7 (Day 0 is the start of the dietary challenge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start2 Jun 2020
- Primary completion25 Sep 2020
- Study completion25 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microbiota Perturbation by an Environmental ChallengeStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sami Damak, Principal investigator, Société des produits Nestlé
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04424329
- Sponsor's protocol ID
- 19.17.NRC
- Status last verified
- Nov 2020
- First submitted
- 8 Jun 2020
- Last updated
- 13 Nov 2020
- 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 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Specific Blend of Fibers and Probiotics on the Microbiome
- ClinicalTrials.gov ID
- NCT04424329
- Acronym / sponsor ID
- 19.17.NRC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 2 Jun 2020 (actual)
- Primary completion
- 25 Sep 2020 (actual)
- Study completion
- 25 Sep 2020 (actual)
- First posted
- 9 Jun 2020 (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 study will investigate the effect of a mix of fibers and probiotics on faecal microbiota challenged by an environmental stress
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutrition intervention | Experimental | Dietary Supplement: Fibers and probioticsIngestion of fibers and probiotics daily for 22 days |
| No intervention | No intervention | –No intervention |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Informed consent signed
- Adult men and women aged 18 to 45 years
- Healthy based on the medical screening visit and medical questionnaire
- BMI in the range of 18.5 to 29.9 kg/m2.
Key exclusion criteria (12 listed)
- Known food allergy and intolerance
- Currently participating in another clinical trial or research project
- Fewer than 5 spontaneous bowel movements per week on average
- Chronic or recurrent diarrhea with spontaneous bowel movements more often than 2 times daily
- Systemic antibacterial/antifungal therapy during the 3 months prior to study enrolment
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 |
|---|---|---|
| Fibers and probioticsA blend of fibers and seven probiotics | Dietary supplement | Nutrition intervention |
Primary outcome
Minimizing microbiota composition change
Time frame: Daily from Day -4 to day + 7 (Day 0 is the start of the challenge)
Shotgum metagenomics
3 secondary outcomes
Increased intestinal microbiota diversity
Time frame: Daily from Day -4 to day + 7 (Day 0 is the start of the dietary challenge)
Increased microbiota gene richness
Time frame: Daily from Day -4 to day + 7 (Day 0 is the start of the dietary challenge)
Gut comfort
Time frame: Daily from Day -10 to day + 7 (Day 0 is the start of the dietary challenge)
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 13 Nov 2020.
- Individual participant dataSharing planned: No
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.
Sami Damak principal investigator
Société des produits Nestlé
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fibers and probiotics in people with Microbiota Perturbation by an Environmental Challenge, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
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 12 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 13 Nov 2020. 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 Switzerland. 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?
Minimizing microbiota composition change (time frame: Daily from Day -4 to day + 7 (Day 0 is the start of the challenge)). 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 13 Nov 2020.