Impact of synbiotic supplementation on infants and toddlers

Artemis: Evaluating the Impact of Synbiotic Supplementation on Infants and Toddlers

This study is testing if a special supplement with good bacteria can help improve gut health and digestion in infants and toddlers.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 2 Months to 24 Months
• Sex: All
• Sponsor: Persephone Biosciences (industry)
• Locations: 1 site (San Diego, California)
• Trial ID: NCT06746285 on ClinicalTrials.gov

What this trial studies

This study evaluates the effects of a synbiotic supplement, which combines beneficial bacteria and human milk oligosaccharides, on the gut microbiome of infants and toddlers. The researchers aim to determine if this supplementation can improve gastrointestinal tolerance and overall gut health in young children. By addressing the lack of important Bifidobacterium species in the infant gut, the study seeks to understand how synbiotics can potentially prevent gastrointestinal issues and immune-related conditions. Participants will receive either the synbiotic supplement or a lactose placebo to assess the differences in outcomes.

Who should consider this trial

Good fit: Ideal candidates for this study are infants and toddlers whose caregivers are willing to participate and provide the synbiotic supplement as directed.

Not a fit: Patients who are not infants or toddlers, or those with existing severe gastrointestinal disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance gut health in infants and toddlers, potentially reducing the risk of gastrointestinal and immune-related disorders.

How similar studies have performed: Other studies have shown promising results with synbiotic supplementation in improving gut health, suggesting that this approach may be effective.

Eligibility criteria

Inclusion Criteria:

1. Evidence of personally signed and dated informed consent document indicating that the caregiver(s) have been informed of all pertinent aspects of the study
2. Caregiver(s) meet the following criteria:

   1. 18 Years or Older
   2. Legal Guardian of the Infant
   3. Intending to cohabitate with the infant/toddler for the duration of the study
   4. Can be reached by phone and email for the duration of the study
   5. Reads, writes, and speaks English
   6. Be able to accurately answer all portions of the questionnaire
   7. Have access to a working freezer
   8. Intending to be primary caregiver and study responder for duration of study
   9. Willing to provide synbiotic either in a bottle or some other format to the infant if on a fully liquid diet
3. 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
4. The infant or toddler enrolled is:

   1. Healthy (has not been diagnosed with any chronic health conditions by a pediatrician)
   2. Still using diapers (to facilitate sample collection), and expected to continue in diapers for the duration of the study

Exclusion Criteria:

1. 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
2. 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:

     i. 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
3. Infants/toddlers with HIV or hepatitis or lactose sensitivity
4. 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
5. Currently participating or having participated in another clinical trial since birth

Where this trial is running

San Diego, California

• Persephone Biosciences — San Diego, California, United States (RECRUITING)

Study contacts

• Study coordinator: Stephen VanDien, PhD

Conditions: Gastrointestinal Tolerance of Probiotics in Infants