NCT06746285

Evaluating the Impact of Synbiotic Supplementation on Infants and Toddlers

Active, enrolled NA Last updated 10 September 2025

What this trial tests

NA trial testing Synbiotic Supplement in Gastrointestinal Tolerance of Probiotics in Infants in 200 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 January 2025

Primary endpoint
30 September 2025

31 December 2025

Quick facts

Lead sponsor	Persephone Biosciences
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	basic science
Enrollment	200
Start date	1 January 2025
Primary completion	30 September 2025
Estimated completion	31 December 2025
Sites	1 location across United States

Drugs / interventions tested

• Synbiotic Supplement — full drug profile →
• Lactose (inactive placebo) — full drug profile →

Conditions studied

• Gastrointestinal Tolerance of Probiotics in Infants — all drugs for Gastrointestinal Tolerance of Probiotics in Infants →

Sponsor

Persephone Biosciences

Who can join

Adults 2 Months to 24 Months, any sex, with Gastrointestinal Tolerance of Probiotics in Infants. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.