Tolerability and Functional Assessment of a Novel Children's Synbiotic
Condition: Constipation; Signs and Symptoms; Digestive Signs and Symptoms; Infrequent or Difficult Evacuation
MeSH terms: Constipation; Signs and Symptoms, Digestive
Study type: Interventional

Summary: 
      Recent data support the use of specific probiotic strains in a pediatric population. However,
      given the wide number of commercial products available, and contradictory data in the
      literature, healthcare providers and consumers are uncertain about whether or not to use
      probiotics in children and which one(s) to choose. While much progress has been made in
      understanding the gastrointestinal microbiota and its role in the balanced development of the
      infant immune system, the tolerability and efficacy of introducing beneficial microbes into
      the pediatric gastrointestinal tract remain underexplored.

      The purpose of this study is to investigate the effect of a 9 strain synbiotic consortium
      comprised of strains with previous pediatric clinical data for use in modulating airway
      sensitivity, gastrointestinal discomfort, dermatological inflammation, and reduction in the
      duration and severity of upper respiratory tract infections in a pediatric population.
    

Detailed description: 
      During infancy and childhood, environmental factors including the maternal vaginal and skin
      microbiomes, breast milk microbiota, breast milk, geographic location, and use of antibiotics
      will exert significant influence over the offspring's microbiota and have a determinant
      impact on their health later in life. Unfavorable environmental exposures, coupled with an
      immature immune system in early life can, therefore, confer suboptimal immune responses that
      can lead to the development of extra-gastrointestinal conditions such as allergic rhinitis,
      asthma, and atopic dermatitis-which affects 15-20% of the world's population. Furthermore,
      while the indiscriminate use of antibiotics has decreased, they remain standard-of-care for
      most childhood infections, and unfortunately, often result in short- or long-term disruption
      of the patient's microbiome.

      Constipation is a common childhood gastrointestinal disorder, with a worldwide prevalence
      between 0.7-29.6%. Its etiology is multifactorial and usually not due to underlying
      conditions. Few studies have explored the implications of the intestinal or fecal microbiota
      in childhood constipation, yet some have shown benefits of various probiotic compositions in
      reducing transit time and improving bowel movement frequency. Dysbiosis of the gut microbiome
      may play an important role in functional constipation.

      PDS-08™ is a novel synbiotic, comprised of nine probiotic bacterial strains and
      fructooligosaccharide with inulin (FOS-inulin) as a prebiotic. A synbiotic is defined as a
      probiotic ("live microorganisms that, when administered in adequate amounts, confer a health
      benefit on the host") plus an established prebiotic ("a substrate that is selectively
      utilized by host microorganisms conferring a health benefit")-or, an untested live microbe
      co-administered with a substrate that it selectively utilizes. The selected probiotics and
      prebiotic in the PDS-08 formulation have shown to improve antibiotic-associated diarrhea,
      gastrointestinal and respiratory tract infections, allergic rhinitis, atopic dermatitis,
      irritable bowel syndrome (IBS) symptoms, and/or microbiota modulation. The positive outcomes
      of these respective studies warrants further investigation of the strains as part of a
      probiotic consortium with the potential to modulate the microbiota, regulate dysbiosis, and
      confer a benefit to host health. There is a need for additional systematic studies on
      probiotic administration in pediatric populations, with a focus on measuring shifts in the
      fecal microbiota and markers of gut health and function. Therefore, the objective of this
      study is to assess the efficacy, tolerability, and safety of a novel synbiotic in healthy
      children with occasional constipation, over 12 weeks, as compared to a sensory-matched
      placebo.

      This is a randomized, 12-week study to compare the efficacy and tolerability of PDS-08 in a
      cohort of 100 healthy children with constipation. 50 subjects will receive PDS-08™ over 12
      weeks, and 50 subjects will receive a placebo. Subjects will provide stool samples at
      baseline and week 12. Safety is a paramount concern in the study design and will be monitored
      carefully throughout the study. Parents or direct relative guardians of study subjects will
      receive extensive education on synbiotic use.
    

Intervention name(s): PDS-08; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): PDS-08 is a novel synbiotic comprised of nine probiotic bacterial strains and FOS-inulin as a prebiotic.; Placebo sachets will contain potato or tapioca maltodextrin.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment