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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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.

Petra Zimmermann, MD, PhD contact

+412063060000

petra.zimmermann@unifr.ch

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

Other trials in Switzerland

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.

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 groups in NCT06396689
Study groupRoleWhat they receive
Preterm-born infants assigned to "synbiotics" (PRET-SYN)Active comparatorNot described
Receives: Dietary Supplement: Synbiotic
Preterm-born infants to "placebo" (PRET-PLC)Placebo comparatorNot described
Receives: Dietary Supplement: Placebo
Term-born infants to "synbiotics" (TERM-SYN)Active comparatorNot described
Receives: Dietary Supplement: Synbiotic
Term-born infants to "placebo" (TERM-PLC)Placebo comparatorNot described
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sleep-wake behavior

    Brief Infant Sleep Questionnaire BISQ, actinometry and sleep-wake diary

    Measured: up to two years of age

  2. Neuronal connectivity

    High-density EEG during sleep

    Measured: up to two years of age

  3. Neurobehavioral development

    Bayley Scales of Infant Development

    Measured: up to two years of age

  4. Behavior

    Infant Behavior Questionnaire

    Measured: up to two years of age

  5. Gut microbiota

    Composition of stool microbiota

    Measured: up to two years of age

  6. Stool metabolome

    Composition of stool metabolites

    Measured: up to two years of age

  7. Breath metabolome

    Composition of breath metabolites

    Measured: up to two years of age

Secondary outcomes (6)
  1. Eczema

    SCORing Atopic Dermatitis scoring system (SCORAD)

    Measured: up to two years of age

  2. Food allergy

    Skin prick test

    Measured: up to two years of age

  3. Rates of infection

    Number of episodes

    Measured: up to two years of age

  4. Breast milk microbiota

    Composition investigated trough shotgun metagenomic sequencing

    Measured: up to two years of age

  5. Nasal microbiota

    Composition investigated trough shotgun metagenomic sequencing

    Measured: up to two years of age

  6. 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.

  1. First posted2 May 2024
  2. Study start1 Mar 2025 (estimated)
  3. Primary completion28 Feb 2029 (estimated)
  4. Study completion28 Feb 2029 (estimated)

Resources

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)
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

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.

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