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NCT04534036 · ClinicalTrials.gov registry record · NA
Tolerability and Functional Assessment of a Novel Children's Synbiotic
A NA study of Constipation and Signs and Symptoms, sponsored by Seed Health.
- Completed
- Registry status
- NA
- Development phase
- 64
- Enrollment target
- 1
- Study location
NCT04534036 is a NA study of Constipation and Signs and Symptoms that has completed, run by Seed Health. The registered enrollment target is 64 participants, below the 204-participant average among 54 other Constipation trials with a reported enrollment target (69% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04534036, a NA study of Constipation and Signs and Symptoms, has completed, sponsored by Seed Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 64 participants
- Enrollment target
- 1
- Study location
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 Studied
Interventions
- OTHER Placebo
- DIETARY_SUPPLEMENT PDS-08
Study Locations (1)
California
- Curebase, Inc. - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2020-08-13 |
| Est. Completion | 2022-02-10 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04534036
The ClinicalTrials.gov registry entry for NCT04534036 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 64 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 204-participant average among 54 other Constipation trials with a reported enrollment target (69% lower). The listed sponsor is Seed Health, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Constipation appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04534036 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT04534036 about?
NCT04534036 is a clinical study titled "Tolerability and Functional Assessment of a Novel Children's Synbiotic". 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 whic...
What is the current status of trial NCT04534036?
This trial is currently completed. It is a NA study. The enrollment target is 64 participants. The study started on 2020-08-13. Estimated completion is 2022-02-10.
What conditions does trial NCT04534036 study?
This clinical trial studies the following conditions: Constipation, Signs and Symptoms, Digestive Signs and Symptoms, Infrequent or Difficult Evacuation.
What interventions are being tested in trial NCT04534036?
The interventions under investigation include: Placebo (OTHER), PDS-08 (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT04534036?
This trial is sponsored by Seed Health, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04534036 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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