HealthyNCT05555004
Evaluation of Probiotic (L.Reuteri) Survival in Presence of Prebiotic Galacto-oligosaccharides
A study testing TEST1 and TEST 2 in people with Healthy, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
Trial summary
This research study will compare the effect of test product #1 (containing a probiotic with the Galacto-OligoSaccharides fiber. GOS) and test product #2 (containing a probiotic without the GOS fiber) to understand how they can contribute to healthy digestion in toddlers between the age of 24 - 36 months. Read more about this study
- Who is it for?
- Ages 24 to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- TEST1 and TEST 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSwitzerland
- Study dates
- 30 Jun 2022to 6 Apr 2023
- 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 24 to 36 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Child is between 24 months to 36 months of age.
- Singleton, full-term gestational birth (≥ 37 completed weeks of gestation), with a birth weight of ≥ 2.5 kg and ≤ 4.5 kg.
- Healthy status based on medical history and physical examination
- Weight- for-age and height-for-age within normal range on local childhood growth chart.
- Written informed consent are obtained from both parents/legally authorized representative (LAR).
- Parents/legally authorized representative must be able to provide evidence of the parental authority and identity.
- Parents /legally authorized representative are of legal age of consent and must understand the informed consent and other study documents.
- Parents/legally authorized representative are willing and able to fulfill the requirements of the study protocol.
Who cannot join
- Known or suspected cows' milk protein intolerance / allergy, or lactose intolerance, or significant food allergies that impact a normal diet.
- Prior to study participation, child has shown limited or no interest in drinking toddler milk.
- Chronic infectious, gastrointestinal, metabolic, or genetic disease, including any disease/condition that impacts feeding or growth.
- Use of systemic antibiotics or anti-mycotic medication in the 4 weeks preceding enrollment.
- Child is currently consuming or has consumed any formulas or taking any supplement containing L. reuteri in the past 3 months.
- Child is currently consuming or has consumed any formulas or taking any supplement containing GOS within the past 48 hrs prior to product in take, and who are not willing accept a temporary cessation of the consumption during the study period.
- Child is currently participating in another investigational clinical trial.
- Family or hierarchical relationships with the CIL team.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Société des Produits Nestlé S.A.
Lausanne, Canton of Vaud, 1000
About this study
This research study will compare the effect of test product #1 (containing a probiotic with the Galacto-OligoSaccharides fiber. GOS) and test product #2 (containing a probiotic without the GOS fiber) to understand how they can contribute to healthy digestion in toddlers between the age of 24 - 36 months. The hypothesis is that L. reuteri from TEST#1 will demonstrate an improved survival in the GIT of toddlers compared to that of TEST#2.
This study is a single-centre, randomized, double-blind, comparator-controlled, parallel group study. The study will be conducted at the Clinical Innovation Lab (CIL) at Nestlé Research.
- Conditions
- Healthy
- Being tested
- TEST1, TEST 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEST1Other
Toddler milk with preconditioned L. reuteri and containing GOS
TEST 2Other
Toddler milk with standard/non-preconditioned L. reuteri and not containing GOS.
| Study group | Role | What they receive |
|---|---|---|
| TEST1 | Experimental | Not described Receives: Other: TEST1 |
| TEST2 | Experimental | Not described Receives: Other: TEST 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colony forming units of feces (CFU/g)
The primary end point is quantification of L. reuteri DSM 17938 in stool using quantitative polymerase chain reaction (qPCR).
Measured: Baseline (visit Day 0), Day 2, Day 3, Day4, Day 5, Day6 Day 7 and D21
Secondary outcomes (4)
Gut microbiota
Diversity and functionality will be evaluated on at least 8 stools samples using shotgun metagenomic sequencing. Structure and prevalence of microbiota and evaluation of taxa and function in the survival of the probiotic.
Measured: Between Day 0 and Day 21
Gastrointestinal (GI) tolerance and stooling patterns
Parent perceptions of GI symptoms and GI-related behaviors using Toddler Gut Comfort Questionnaire (GCQ) and stool frequency and consistency
Measured: Between Day 0 and Day 21
Assessment of dietary variety
Dietary variety assessed using a parent-reported Food Frequency Questionnaire (FFQ)
Measured: Between Day 0 and Day 21
Safety and tolerability
- Adverse events type, incidence, severity, and relationship to TEST1 and TEST2 products.
Measured: Between Day 0 and Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2022
- Study start30 Jun 2022
- Primary completion6 Apr 2023
- Study completion6 Apr 2023
Why it stopped: Based on slow recruitement and Interim analysis recommendation, the core team decide to stop the study
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.
- 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
- Parallel groups
- Model description
- comparator-controlled
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05555004
- Sponsor's protocol ID
- 2113NR
- Status last verified
- May 2023
- First submitted
- 14 Jul 2022
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Probiotic (L.Reuteri) Survival in Presence of Prebiotic Galacto-oligosaccharides
- ClinicalTrials.gov ID
- NCT05555004
- Acronym / sponsor ID
- 2113NR
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Based on slow recruitement and Interim analysis recommendation, the core team decide to stop the study
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 30 Jun 2022 (actual)
- Primary completion
- 6 Apr 2023 (actual)
- Study completion
- 6 Apr 2023 (actual)
- First posted
- 26 Sep 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.
This research study will compare the effect of test product #1 (containing a probiotic with the Galacto-OligoSaccharides fiber. GOS) and test product #2 (containing a probiotic without the GOS fiber) to understand how they can contribute to healthy digestion in toddlers between the age of 24 - 36 months. The hypothesis is that L. reuteri from TEST#1 will demonstrate an improved survival in the GIT of toddlers compared to that of TEST#2.
This study is a single-centre, randomized, double-blind, comparator-controlled, parallel group study. The study will be conducted at the Clinical Innovation Lab (CIL) at Nestlé Research.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- comparator-controlled
| Arm | Type | Receives |
|---|---|---|
| TEST1 | Experimental | Other: TEST1 |
| TEST2 | Experimental | Other: TEST 2 |
Who may qualify
- Ages
- 24 to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Child is between 24 months to 36 months of age.
- Singleton, full-term gestational birth (≥ 37 completed weeks of gestation), with a birth weight of ≥ 2.5 kg and ≤ 4.5 kg.
- Healthy status based on medical history and physical examination
- Weight- for-age and height-for-age within normal range on local childhood growth chart.
- Written informed consent are obtained from both parents/legally authorized representative (LAR).
Key exclusion criteria (8 listed)
- Known or suspected cows' milk protein intolerance / allergy, or lactose intolerance, or significant food allergies that impact a normal diet.
- Prior to study participation, child has shown limited or no interest in drinking toddler milk.
- Chronic infectious, gastrointestinal, metabolic, or genetic disease, including any disease/condition that impacts feeding or growth.
- Use of systemic antibiotics or anti-mycotic medication in the 4 weeks preceding enrollment.
- Child is currently consuming or has consumed any formulas or taking any supplement containing L. reuteri in the past 3 months.
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 |
|---|---|---|
| TEST1Toddler milk with preconditioned L. reuteri and containing GOS | Other | TEST1 |
| TEST 2Toddler milk with standard/non-preconditioned L. reuteri and not containing GOS. | Other | TEST2 |
Primary outcome
Colony forming units of feces (CFU/g)
Time frame: Baseline (visit Day 0), Day 2, Day 3, Day4, Day 5, Day6 Day 7 and D21
The primary end point is quantification of L. reuteri DSM 17938 in stool using quantitative polymerase chain reaction (qPCR).
4 secondary outcomes
Gut microbiota
Time frame: Between Day 0 and Day 21
Gastrointestinal (GI) tolerance and stooling patterns
Time frame: Between Day 0 and Day 21
Assessment of dietary variety
Time frame: Between Day 0 and Day 21
Safety and tolerability
Time frame: Between Day 0 and Day 21
Results and safety
The study was stopped early (reason given: Based on slow recruitement and Interim analysis recommendation, the core team decide to stop the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TEST1 and TEST 2 in people with Healthy, 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 8 inclusion and 8 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: stopped early, as of the sponsor's last update on 6 May 2023. 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 was stopped early (reason given: Based on slow recruitement and Interim analysis recommendation, the core team decide to stop the study). Results are not available in the source record.
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?
Colony forming units of feces (CFU/g) (time frame: Baseline (visit Day 0), Day 2, Day 3, Day4, Day 5, Day6 Day 7 and D21). 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 6 May 2023.