Sleep ProblemNapBiomeNCT06396689
NapBiome: Targeting Gut Microbiota and Sleep Rhythm to Improve Developmental and Behavioral Outcomes in Early Childhood
A study testing Synbiotic in people with Sleep Problem and Neurobehavioral Manifestations, run by Petra Zimmermann at 2 sites in Switzerland.
Trial summary
The gut-brain axis plays a crucial role in the regulation and development of psychological and physical processes. The first year of life is a critical period for the development of the gut microbiome, which parallels important milestones in establishing sleep rhythm and neurodevelopment. Read more about this study
- Who is it for?
- Ages 0 to 7 daysHealthy volunteers can take part
- Conditions the study is for
- Sleep Problem, Neurobehavioral Manifestations
- What is being tested?
- Synbiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 380 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 1 Mar 2025to 28 Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 0 to 7 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Preterm-arm:
- neonates born between a gestational age of 34 0/7 to 36 6/7 weeks
- partially breast-fed at the time of inclusion
- Term-arm
- neonates born at a gestational age of ≥ 37 0/7 weeks Infants need to be
- partially breast-fed at the time of inclusion
Who cannot join
- Infants who
- receive probiotics outside the trial design
- have a birth weight < 1500 g
- were prenatally drug-exposed (cannabis, cocaine, heroin, opiates, and alcohol)
- have suspected or confirmed immunodeficiency
- have an underlying disease (excluding transient conditions such as alimentation problems, hyperbilirubinemia, hypoglycaemia, anemia, respiratory distress syndrome or apnea-bradycardia syndrome), congenital malformations, central nervous system disease or injury or congenital infections
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland2 sites
Hopital cantonal Fribourg
Fribourg, Canton of Fribourg, 1700
Cantonal Hospital
Lucerne, Canton of Lucerne, 6000
Martin Stocker, MD, +4141 205 32 31, martin.stocker@luks.ch
About this study
The gut-brain axis plays a crucial role in the regulation and development of psychological and physical processes. The first year of life is a critical period for the development of the gut microbiome, which parallels important milestones in establishing sleep rhythm and neurodevelopment. Growing evidence suggests that the gut microbiome influences sleep, cognition, and early neurodevelopment. For term and preterm-born infants, difficulties in sleep regulation can have major consequences on infants' health, attachment between infants and their caregivers, and can even lead to life-threatening consequences such as shaken-baby syndrome. Preterm born infants are at even higher risk for sleep and neurodevelopmental problems. Although neonatal care has improved over recent decades, preterm birth rates continue to rise and lead to a wide range of neurodevelopmental disabilities that are unaddressed with current therapies. Given the importance of sleep and the gut microbiome for brain maturation, neurodevelopment, and behavior, identifying effective interventions within the gut-brain axis at the beginning of life is likely to have long-term implications for health and development of at-risk infants.
The aims of this project are to I) demonstrate the association between the gut microbiome, sleep patterns and health outcomes in children up to two years of age; and II) to leverage gut microbiome-brain-sleep interactions to develop new intervention strategies for at-risk infants. The investigators hypothesize that the establishment of a healthy gut microbiome during early life is crucial for both short- and long-term child health outcomes, as dysbiosis can harm sleep regulation, brain maturation, and neurobehavioral development. The investigators predict that the administration of synbiotics improves microbiota establishment, sleep rhythm, and neurodevelopmental outcomes.
Read more
This project integrates a randomized controlled trial (RCT), ex vivo, and in silico experiments with I) key technology platforms for computational modeling to capture the ontogenic norms of gut microbiota; II) neuronal and actimetry-based quantification of multidimensional aspects of infant sleep; III) breath metabolomics (exhalomics) of host and microbiome metabolism; and IV) high-throughput ex vivo models for investigating host-microbiome interactions. Outcomes include I) an understanding of age-normative microbiome composition, its variation (circadian, inter-individual), and the factors that influence the microbiome's plasticity throughout infancy; II) actionable knowledge of microbial species and metabolism that can be targeted to modify sleep regulation and improve neurodevelopmental outcomes, especially in at-risk infants (e.g., preterm-born); III) microbial and metabolic biomarkers with diagnostic potential for later regulatory and behavioral problems; and IV) an open-source analytical "toolbox" for microbial multi-omics that can be immediately applied in other areas of microbiome-host research. To achieve these goals, our strategy combines multiple disciplines focusing on factors that exert the greatest influence on health during infancy: the gut microbiome, sleep regulation, and neurodevelopment.
The impact of this project is substantial and globally relevant, as it advances possible treatment options for supporting neurodevelopmental health in preterm- and term-born infants, explores novel translational approaches for addressing regulatory difficulties, and provides key information for tailored prophylactic synbiotics and possible development of "post-biotics". Further, the study supports the investigation of biomarkers for neurodevelopment and advances early prevention of developmental and mental illnesses.
- Conditions
- Sleep Problem, Neurobehavioral Manifestations
- Being tested
- Synbiotic, Placebo
- Keywords
- microbiome, infant, gut, metagenomics, development, metabolics, pre-term, probiotics, synbiotics, brain-gut
- Medical subject headings
- Parasomnias, Neurobehavioral Manifestations, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SynbioticDietary supplement
The capsule contains Lactobacillus helveticus R0052, Bifidobacterium infantis R0033, and Bifidobacterium bifidum R0071 (3 billion bacteria per capsule), as well as zinc oxide, potato starch fructooligosaccharides, coating agent, methyl hydroxypropyl cellulose, anti-caking agent and magnesium stearat
PlaceboDietary supplement
The capsule contains zinc oxide, coating agent, methyl hydroxypropyl cellulose, anti-caking agent and magnesium stearat
| Study group | Role | What they receive |
|---|---|---|
| Preterm-born infants assigned to "synbiotics" (PRET-SYN) | Active comparator | Not described Receives: Dietary Supplement: Synbiotic |
| Preterm-born infants to "placebo" (PRET-PLC) | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
| Term-born infants to "synbiotics" (TERM-SYN) | Active comparator | Not described Receives: Dietary Supplement: Synbiotic |
| Term-born infants to "placebo" (TERM-PLC) | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep-wake behavior
Brief Infant Sleep Questionnaire BISQ, actinometry and sleep-wake diary
Measured: up to two years of age
Neuronal connectivity
High-density EEG during sleep
Measured: up to two years of age
Neurobehavioral development
Bayley Scales of Infant Development
Measured: up to two years of age
Behavior
Infant Behavior Questionnaire
Measured: up to two years of age
Gut microbiota
Composition of stool microbiota
Measured: up to two years of age
Stool metabolome
Composition of stool metabolites
Measured: up to two years of age
Breath metabolome
Composition of breath metabolites
Measured: up to two years of age
Secondary outcomes (6)
Eczema
SCORing Atopic Dermatitis scoring system (SCORAD)
Measured: up to two years of age
Food allergy
Skin prick test
Measured: up to two years of age
Rates of infection
Number of episodes
Measured: up to two years of age
Breast milk microbiota
Composition investigated trough shotgun metagenomic sequencing
Measured: up to two years of age
Nasal microbiota
Composition investigated trough shotgun metagenomic sequencing
Measured: up to two years of age
Oral microbiota
Composition investigated trough shotgun metagenomic sequencing
Measured: up to two years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start1 Mar 2025 (estimated)
- Primary completion28 Feb 2029 (estimated)
- Study completion28 Feb 2029 (estimated)
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 Sleep ProblemStudies 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
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Petra Zimmermann
- Sponsor type
- University, hospital or other
- Collaborators
- University of Luzern, Swiss Federal Institute of Technology in Zurich (ETHZ)
- Responsible party
- Sponsor-investigator, Petra Zimmermann, University of Fribourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06396689
- Sponsor's protocol ID
- 123
- Acronym
- NapBiome
- Status last verified
- Feb 2025
- First submitted
- 10 Apr 2024
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zimmermann P, Kurth S, Giannoukos S, Stocker M, Bokulich NA. NapBiome trial: Targeting gut microbiota to improve sleep rhythm and developmental and behavioural outcomes in early childhood in a birth cohort in Switzerland - a study protocol. BMJ Open. 2025 Mar 3;15(3):e092938. doi: 10.1136/bmjopen-2024-092938.
PubMed 40032396
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NapBiome: Targeting Gut Microbiota and Sleep Rhythm to Improve Developmental and Behavioral Outcomes in Early Childhood
- ClinicalTrials.gov ID
- NCT06396689
- Acronym / sponsor ID
- NapBiome / 123
- Conditions
- Sleep Problem, Neurobehavioral Manifestations
- Keywords
- microbiome, infant, gut, metagenomics, development, metabolics, pre-term, probiotics
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- Petra ZimmermannUniversity, hospital or other
- Collaborators
- University of Luzern, Swiss Federal Institute of Technology in Zurich (ETHZ)
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 28 Feb 2029 (estimated)
- Study completion
- 28 Feb 2029 (estimated)
- First posted
- 2 May 2024 (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 gut-brain axis plays a crucial role in the regulation and development of psychological and physical processes. The first year of life is a critical period for the development of the gut microbiome, which parallels important milestones in establishing sleep rhythm and neurodevelopment. Growing evidence suggests that the gut microbiome influences sleep, cognition, and early neurodevelopment. For term and preterm-born infants, difficulties in sleep regulation can have major consequences on infants' health, attachment between infants and their caregivers, and can even lead to life-threatening consequences such as shaken-baby syndrome. Preterm born infants are at even higher risk for sleep and neurodevelopmental problems. Although neonatal care has improved over recent decades, preterm birth rates continue to rise and lead to a wide range of neurodevelopmental disabilities that are unaddressed with current therapies. Given the importance of sleep and the gut microbiome for brain maturation, neurodevelopment, and behavior, identifying effective interventions within the gut-brain axis at the beginning of life is likely to have long-term implications for health and development of at-risk infants.
The aims of this project are to I) demonstrate the association between the gut microbiome, sleep patterns and health outcomes in children up to two years of age; and II) to leverage gut microbiome-brain-sleep interactions to develop new intervention strategies for at-risk infants. The investigators hypothesize that the establishment of a healthy gut microbiome during early life is crucial for both short- and long-term child health outcomes, as dysbiosis can harm sleep regulation, brain maturation, and neurobehavioral development. The investigators predict that the administration of synbiotics improves microbiota establishment, sleep rhythm, and neurodevelopmental outcomes.
This project integrates a randomized controlled trial (RCT), ex vivo, and in silico experiments with I) key technology platforms for computational modeling to capture the ontogenic norms of gut microbiota; II) neuronal and actimetry-based quantification of multidimensional aspects of infant sleep; III) breath metabolomics (exhalomics) of host and microbiome metabolism; and IV) high-throughput ex vivo models for investigating host-microbiome interactions. Outcomes include I) an understanding of age-normative microbiome composition, its variation (circadian, inter-individual), and the factors that influence the microbiome's plasticity throughout infancy; II) actionable knowledge of microbial species and metabolism that can be targeted to modify sleep regulation and improve neurodevelopmental outcomes, especially in at-risk infants (e.g., preterm-born); III) microbial and metabolic biomarkers with diagnostic potential for later regulatory and behavioral problems; and IV) an open-source analytical "toolbox" for microbial multi-omics that can be immediately applied in other areas of microbiome-host research. To achieve these goals, our strategy combines multiple disciplines focusing on factors that exert the greatest influence on health during infancy: the gut microbiome, sleep regulation, and neurodevelopment.
The impact of this project is substantial and globally relevant, as it advances possible treatment options for supporting neurodevelopmental health in preterm- and term-born infants, explores novel translational approaches for addressing regulatory difficulties, and provides key information for tailored prophylactic synbiotics and possible development of "post-biotics". Further, the study supports the investigation of biomarkers for neurodevelopment and advances early prevention of developmental and mental illnesses.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Preterm-born infants assigned to "synbiotics" (PRET-SYN) | Active comparator | Dietary Supplement: Synbiotic |
| Preterm-born infants to "placebo" (PRET-PLC) | Placebo comparator | Dietary Supplement: Placebo |
| Term-born infants to "synbiotics" (TERM-SYN) | Active comparator | Dietary Supplement: Synbiotic |
| Term-born infants to "placebo" (TERM-PLC) | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 0 to 7 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- neonates born between a gestational age of 34 0/7 to 36 6/7 weeks
- partially breast-fed at the time of inclusion
- Term-arm
- neonates born at a gestational age of ≥ 37 0/7 weeks Infants need to be
- partially breast-fed at the time of inclusion
Key exclusion criteria (6 listed)
- Infants who
- receive probiotics outside the trial design
- have a birth weight < 1500 g
- were prenatally drug-exposed (cannabis, cocaine, heroin, opiates, and alcohol)
- have suspected or confirmed immunodeficiency
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 |
|---|---|---|
| SynbioticThe capsule contains Lactobacillus helveticus R0052, Bifidobacterium infantis R0033, and Bifidobacterium bifidum R0071 (3 billion bacteria per capsule), as well as zinc oxide, potato starch fructooligosaccharides, coating agent, methyl hydroxypropyl cellulose, anti-caking agent and magnesium stearat | Dietary supplement | Preterm-born infants assigned to "synbiotics" (PRET-SYN), Term-born infants to "synbiotics" (TERM-SYN) |
| PlaceboThe capsule contains zinc oxide, coating agent, methyl hydroxypropyl cellulose, anti-caking agent and magnesium stearat | Dietary supplement | Preterm-born infants to "placebo" (PRET-PLC), Term-born infants to "placebo" (TERM-PLC) |
Primary outcome
Sleep-wake behavior
Time frame: up to two years of age
Brief Infant Sleep Questionnaire BISQ, actinometry and sleep-wake diary
Neuronal connectivity
Time frame: up to two years of age
High-density EEG during sleep
Neurobehavioral development
Time frame: up to two years of age
Bayley Scales of Infant Development
Behavior
Time frame: up to two years of age
Infant Behavior Questionnaire
Gut microbiota
Time frame: up to two years of age
Composition of stool microbiota
Stool metabolome
Time frame: up to two years of age
Composition of stool metabolites
Breath metabolome
Time frame: up to two years of age
Composition of breath metabolites
6 secondary outcomes
Eczema
Time frame: up to two years of age
Food allergy
Time frame: up to two years of age
Rates of infection
Time frame: up to two years of age
Breast milk microbiota
Time frame: up to two years of age
Nasal microbiota
Time frame: up to two years of age
Oral microbiota
Time frame: up to two years of age
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Derived from this study: PubMed 40032396Zimmermann P, Kurth S, Giannoukos S, Stocker M, Bokulich NA. NapBiome trial: Targeting gut microbiota to improve sleep rhythm and developmental and behavioural outcomes in early childhood in a birth cohort in Switzerland - a study protocol. BMJ Open. 2025 Mar 3;15(3):e092938. doi: 10.1136/bmjopen-2024-092938.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Synbiotic in people with Sleep Problem and Neurobehavioral Manifestations, run by Petra Zimmermann at 2 sites 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 6 inclusion and 6 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: opening soon, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Petra Zimmermann, MD, PhD (+412063060000, petra.zimmermann@unifr.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep-wake behavior (time frame: up to two years of age). The study lists 7 primary outcomes in all. 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 NCT06396689, 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 20 Feb 2025.