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Tolerability and Functional Assessment of a Novel Children's Synbiotic

NCT04534036 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2022-10-25

No results posted yet for this study

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.

Conditions

  • Constipation
  • Signs and Symptoms
  • Digestive Signs and Symptoms
  • Infrequent or Difficult Evacuation

Interventions

DIETARY_SUPPLEMENT

PDS-08

PDS-08 is a novel synbiotic comprised of nine probiotic bacterial strains and FOS-inulin as a prebiotic.

OTHER

Placebo

Placebo sachets will contain potato or tapioca maltodextrin.

Sponsors & Collaborators

  • Curebase Inc.

    collaborator INDUSTRY

  • Seed Health

    lead INDUSTRY

Principal Investigators

  • Charles Baum, MD · Encore Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-13
Primary Completion
2022-01-14
Completion
2022-02-10

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04534036 on ClinicalTrials.gov