Gastrointestinal Tolerance of Probiotics in InfantsNCT06746285
Evaluating the Impact of Synbiotic Supplementation on Infants and Toddlers
A study testing Synbiotic Supplement in people with Gastrointestinal Tolerance of Probiotics in Infants, run by Persephone Biosciences at 1 site in United States.
Trial summary
Background and Significance: Bifidobacterium longum subspecies infantis (B. infantis) and other infant associated Bifidobacterium (such as Bifidobacterium longum subspecies longum and Bifidobacterium breve) are known to be important bacteria in the infant gut microbiome. Read more about this study
- Who is it for?
- Ages 2 to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Tolerance of Probiotics in Infants
- What is being tested?
- Synbiotic Supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2025to 31 Dec 2025
- 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 2 to 24 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Evidence of personally signed and dated informed consent document indicating that the caregiver(s) have been informed of all pertinent aspects of the study
- Caregiver(s) meet the following criteria:
- 18 Years or Older
- Legal Guardian of the Infant
- Intending to cohabitate with the infant/toddler for the duration of the study
- Can be reached by phone and email for the duration of the study
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- Reads, writes, and speaks English
- Be able to accurately answer all portions of the questionnaire
- Have access to a working freezer
- Intending to be primary caregiver and study responder for duration of study
- Willing to provide synbiotic either in a bottle or some other format to the infant if on a fully liquid diet
- The PI considers the Caregiver likely to adequately comply with the study protocol requirements based on demonstrated compliance with initial questionnaires and agreement to complete all diaries
- The infant or toddler enrolled is:
- Healthy (has not been diagnosed with any chronic health conditions by a pediatrician)
- Still using diapers (to facilitate sample collection), and expected to continue in diapers for the duration of the study
Who cannot join
- Infants/toddlers who have a medical condition or history that could increase the risk associated with study participation or interfere with the interpretation of study results, including:
- Evidence of major congenital malformations (e.g., cleft palate, extremity malformation)
- Any history or suspicion of systemic or congenital infections (e.g., human immunodeficiency virus, cytomegalovirus, syphilis)
- Severe gastroesophageal reflux (throwing up or spitting up more than a teaspoon of milk > 8 times daily)
- Chronic vomiting (projectile, bilious or bloody emesis)
- Other severe medical or laboratory abnormality (acute or chronic) which, in the judgment of the investigator, would make the toddler inappropriate for entry into the study
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- Infants/toddlers who are presently receiving or have received within three months prior to enrollment the following:
- Probiotic supplements
- Antibiotics
- Medication(s) or supplement(s) which are known or suspected to affect the following:
- fat digestion, absorption, and/or metabolism (e.g., pancreatic enzymes) ii. stool characteristics (e.g., glycerin suppositories, bismuth-containing medications, docusate, Maltsupex, or lactulose) iii. growth (e.g. insulin or growth hormone) iv. gastric acid secretion v. microbiome
- Infants/toddlers with HIV or hepatitis or lactose sensitivity
- Infants/toddlers exposed to or displaying symptoms of a disease within 1 month of enrollment, including:
- Exposure to COVID-19
- Hematochezia (blood in the stools)
- Diarrhea (watery stools that takes the shape of a container > 5x daily)
- Fever (38.2 degrees)
- Any other symptom which, in the judgment of the investigator, would make the infant inappropriate for entry into the study
- Currently participating or having participated in another clinical trial since birth
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Artemis: Evaluating the Impact of Synbiotic Supplementation on Infants and Toddlers
Background and Significance:
Bifidobacterium longum subspecies infantis (B. infantis) and other infant associated Bifidobacterium (such as Bifidobacterium longum subspecies longum and Bifidobacterium breve) are known to be important bacteria in the infant gut microbiome. A lack of Bifidobacterium in the infant gut may lead to disordered development of the infant microbiome and immune system, which can contribute to the development of gastrointestinal issues, pathogenic infections, and immune-related conditions including allergic disease and autoimmune disorders. The investigators hypothesize that establishing Bifidobacterium in the infant gut through delivery of a synbiotic, containing bifidobacterium and human milk oligosaccharides (HMOs; Bifidobacterium's primary nutrient source) may modulate the microbiome and correct this disruption.
Read more
Research Question:
Does synbiotic supplementation on infants and toddlers of various ages alter the gut microbiome as measured by GI-tolerance, fecal microbiome composition, and fecal metabolic profile?
Objectives:
- Demonstrate shifts in microbiome composition and metabolism
- Demonstrate tolerance by observing neutral or positive shifts in GI related behaviors
Study Design Overview:
Participants Infants aged 2-24 months will be enrolled to evaluate the ability of a synbiotic (human milk oligosaccharide + a Bifidobacterium blend (B. infantis, B. longum, and B. breve)) to modulate the gut microbiome. Infants will be randomly split into two cohorts, one that receives synbiotic supplementation and one that receives a placebo control (lactose).
Initially, only ages 12-24 months will be enrolled (first 25 participants), and a safety review will be performed prior to enrolling younger infants.
Cohorts
- Cohort 1 (supplementation) participants will be aged 2 months to 24 months. They will receive synbiotic supplementation for 1 month.
- Cohort 2 (no supplementation) participants will be aged 2 months to 24 months. Will receive placebo (lactose) over the course of 1 month.
Design Caretakers will be recruited and screened using an online questionnaire to determine eligibility and cohort assignment. They will give consent using an online one-party consent form (Appendix 1). Participants will be distributed randomly between cohorts 1 and 2. Participants will be shipped the synbiotic or placebo (lactose) and a set of stool sampling kits. Calls with the participant will take place throughout the study as necessary to explain participant responsibilities and ensure compliance. Two sample types will be collected during the study, a full fecal sample and a DNA/RNA tube only. The full fecal sample will be collected at the beginning and end of supplementation and the DNA/RNA tube only will be collected at all other time points. Samples will be collected at supplementation start, one week after supplementation, four weeks after supplementation start (coinciding with the end of supplementation) and 6 weeks after supplementation start (coinciding with a 2 week washout period). Journals and questionnaires will be used for the duration of supplementation as well as 2 weeks before and after to assess the impact of supplementation.
Laboratory Assessments:
Stool samples will be obtained for each subject. The first sample will be taken before supplementation start. Additional samples will be collected: after 1 week of supplementation, after 1 month of supplementation, and after a 2 week period of no supplementation (a washout period). All samples will be collected at home and shipped back to Persephone Biosciences for processing. The initial sample and the sample after 4 weeks of supplementation will be full samples for metagenomic, metabolomic, and proteomic analysis. The 1 week after supplementation and 2 week post supplementation samples will be DNA/RNA tube samples for metagenomics only. Microbial whole genome sequencing, metabolite analysis, and immune profiling will be performed on stool from complete stool kits. Microbial whole genome sequencing alone will be performed on the DNA/RNA tube kits.
Data Collection:
Demographic data, general health information, diet and lifestyle information will be collected from the subjects (all self-reported). Journals and questionnaires will be used to evaluate the impact of the synbiotic.
- Being tested
- Synbiotic Supplement, Lactose (inactive placebo)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synbiotic SupplementDietary supplement
Also called probiotic, synbiotic
Participants will be given 1g of a synbiotic product each day, containing 4 microbial strains isolated from an infant gut (total of 1 billion cfu) and a mixture of 4 human milk oligosaccharides. Parents will administer the product by dissolving in breast milk, formula, or water, or mixing with food.
Lactose (inactive placebo)Dietary supplement
Participants will be given 1g of lactose as a placebo. Parents will administer the product by dissolving in breast milk, formula, or water, or mixing with food.
| Study group | Role | What they receive |
|---|---|---|
| Synbiotic Supplement | Active comparator | Participants aged 2 months to 24 months will receive daily synbiotic supplementation (probiotic+ prebiotic) for 1 month Receives: Dietary Supplement: Synbiotic Supplement |
| Lactose | Placebo comparator | Participants aged 2 months to 24 months will receive daily placebo (lactose) for 1 month Receives: Dietary Supplement: Lactose (inactive placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate gastrointestinal tolerance of synbiotic supplementation
A modified GIGER index score will be used to determine if there are adverse outcomes related to the synbiotic. This is a scale from 23 to 138, with higher numbers indicating a higher degree of GI discomfort.
Measured: 1 month
Secondary outcomes (3)
Determine impact of supplementation on microbiome composition during intervention
Overall fecal microbiota composition will be assessed using next generation sequencing (NGS) technology. Outcome measure is a list of microbial species and % abundance in each sample, and microbes with differential abundance between the intervention and placebo will be determined.
Measured: 2 months
Determine impact of supplementation on gene function repertoire of the microbiome
Functional genomics will be assessed from the metagenomic sequence data. Metabolic functions with differential abundance between supplementation and placebo will be determined.
Measured: 2 months
Determine rate of probiotic strain colonization
For the participants receiving the synbiotic supplement, a strain-specific microbial classifier will be applied to the sequence data to determine presence of the strains contained in the supplement. For each strain, the fraction of participants in which it is detected will be determined.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start1 Jan 2025
- Primary completion30 Sep 2025
- Study completion31 Dec 2025
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 Gastrointestinal Tolerance of Probiotics in InfantsStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Persephone Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06746285
- Sponsor's protocol ID
- PB-2024-02
- Status last verified
- Aug 2026
- First submitted
- 11 Dec 2024
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will only be used within the company for trial logistics. Only a limited number of employees, who are involved with stool kit shipping and participant communication, will have access to IPD.
Publications
Pados et al 2021, Global Pediatric Health, 8:1-8
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artemis: Evaluating the Impact of Synbiotic Supplementation on Infants and Toddlers
- ClinicalTrials.gov ID
- NCT06746285
- Acronym / sponsor ID
- PB-2024-02
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Persephone BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 24 Dec 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.
Background and Significance:
Bifidobacterium longum subspecies infantis (B. infantis) and other infant associated Bifidobacterium (such as Bifidobacterium longum subspecies longum and Bifidobacterium breve) are known to be important bacteria in the infant gut microbiome. A lack of Bifidobacterium in the infant gut may lead to disordered development of the infant microbiome and immune system, which can contribute to the development of gastrointestinal issues, pathogenic infections, and immune-related conditions including allergic disease and autoimmune disorders. The investigators hypothesize that establishing Bifidobacterium in the infant gut through delivery of a synbiotic, containing bifidobacterium and human milk oligosaccharides (HMOs; Bifidobacterium's primary nutrient source) may modulate the microbiome and correct this disruption.
Research Question:
Does synbiotic supplementation on infants and toddlers of various ages alter the gut microbiome as measured by GI-tolerance, fecal microbiome composition, and fecal metabolic profile?
Objectives:
- Demonstrate shifts in microbiome composition and metabolism
- Demonstrate tolerance by observing neutral or positive shifts in GI related behaviors
Study Design Overview:
Participants Infants aged 2-24 months will be enrolled to evaluate the ability of a synbiotic (human milk oligosaccharide + a Bifidobacterium blend (B. infantis, B. longum, and B. breve)) to modulate the gut microbiome. Infants will be randomly split into two cohorts, one that receives synbiotic supplementation and one that receives a placebo control (lactose).
Initially, only ages 12-24 months will be enrolled (first 25 participants), and a safety review will be performed prior to enrolling younger infants.
Cohorts
- Cohort 1 (supplementation) participants will be aged 2 months to 24 months. They will receive synbiotic supplementation for 1 month.
- Cohort 2 (no supplementation) participants will be aged 2 months to 24 months. Will receive placebo (lactose) over the course of 1 month.
Design Caretakers will be recruited and screened using an online questionnaire to determine eligibility and cohort assignment. They will give consent using an online one-party consent form (Appendix 1). Participants will be distributed randomly between cohorts 1 and 2. Participants will be shipped the synbiotic or placebo (lactose) and a set of stool sampling kits. Calls with the participant will take place throughout the study as necessary to explain participant responsibilities and ensure compliance. Two sample types will be collected during the study, a full fecal sample and a DNA/RNA tube only. The full fecal sample will be collected at the beginning and end of supplementation and the DNA/RNA tube only will be collected at all other time points. Samples will be collected at supplementation start, one week after supplementation, four weeks after supplementation start (coinciding with the end of supplementation) and 6 weeks after supplementation start (coinciding with a 2 week washout period). Journals and questionnaires will be used for the duration of supplementation as well as 2 weeks before and after to assess the impact of supplementation.
Laboratory Assessments:
Stool samples will be obtained for each subject. The first sample will be taken before supplementation start. Additional samples will be collected: after 1 week of supplementation, after 1 month of supplementation, and after a 2 week period of no supplementation (a washout period). All samples will be collected at home and shipped back to Persephone Biosciences for processing. The initial sample and the sample after 4 weeks of supplementation will be full samples for metagenomic, metabolomic, and proteomic analysis. The 1 week after supplementation and 2 week post supplementation samples will be DNA/RNA tube samples for metagenomics only. Microbial whole genome sequencing, metabolite analysis, and immune profiling will be performed on stool from complete stool kits. Microbial whole genome sequencing alone will be performed on the DNA/RNA tube kits.
Data Collection:
Demographic data, general health information, diet and lifestyle information will be collected from the subjects (all self-reported). Journals and questionnaires will be used to evaluate the impact of the synbiotic.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Synbiotic Supplement | Active comparator | Dietary Supplement: Synbiotic SupplementParticipants aged 2 months to 24 months will receive daily synbiotic supplementation (probiotic+ prebiotic) for 1 month |
| Lactose | Placebo comparator | Dietary Supplement: Lactose (inactive placebo)Participants aged 2 months to 24 months will receive daily placebo (lactose) for 1 month |
Who may qualify
- Ages
- 2 to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (15 listed)
- Evidence of personally signed and dated informed consent document indicating that the caregiver(s) have been informed of all pertinent aspects of the study
- Caregiver(s) meet the following criteria:
- The PI considers the Caregiver likely to adequately comply with the study protocol requirements based on demonstrated compliance with initial questionnaires and agreement to complete all diaries
- The infant or toddler enrolled is:
Key exclusion criteria (19 listed)
- Infants/toddlers who have a medical condition or history that could increase the risk associated with study participation or interfere with the interpretation of study results, including:
- Infants/toddlers who are presently receiving or have received within three months prior to enrollment the following:
- Infants/toddlers with HIV or hepatitis or lactose sensitivity
- Infants/toddlers exposed to or displaying symptoms of a disease within 1 month of enrollment, including:
- Currently participating or having participated in another clinical trial since birth
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 |
|---|---|---|
| Synbiotic SupplementAlso: probiotic, synbioticParticipants will be given 1g of a synbiotic product each day, containing 4 microbial strains isolated from an infant gut (total of 1 billion cfu) and a mixture of 4 human milk oligosaccharides. Parents will administer the product by dissolving in breast milk, formula, or water, or mixing with food. | Dietary supplement | Synbiotic Supplement |
| Lactose (inactive placebo)Participants will be given 1g of lactose as a placebo. Parents will administer the product by dissolving in breast milk, formula, or water, or mixing with food. | Dietary supplement | Lactose |
Primary outcome
Evaluate gastrointestinal tolerance of synbiotic supplementation
Time frame: 1 month
A modified GIGER index score will be used to determine if there are adverse outcomes related to the synbiotic. This is a scale from 23 to 138, with higher numbers indicating a higher degree of GI discomfort.
3 secondary outcomes
Determine impact of supplementation on microbiome composition during intervention
Time frame: 2 months
Determine impact of supplementation on gene function repertoire of the microbiome
Time frame: 2 months
Determine rate of probiotic strain colonization
Time frame: 2 months
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 25 Aug 2026.
- BackgroundPados et al 2021, Global Pediatric Health, 8:1-8
- Individual participant dataSharing planned: No. IPD will only be used within the company for trial logistics. Only a limited number of employees, who are involved with stool kit shipping and participant communication, will have access to IPD.
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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 Synbiotic Supplement in people with Gastrointestinal Tolerance of Probiotics in Infants, run by Persephone Biosciences at 1 site in United States.
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 15 inclusion and 19 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 25 Aug 2026. 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 United States. 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?
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?
Evaluate gastrointestinal tolerance of synbiotic supplementation (time frame: 1 month). 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 NCT06746285, 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 25 Aug 2026.