Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed NA study of Constipation and Signs and Symptoms, sponsored by Seed Health.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Assessed as the change from baseline and compared to placebo for the continuous variable estimated using a linear mixed model.
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 |
What the finished NCT04534036 record still lists
NCT04534036 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 204-participant average among 54 other Constipation trials with a reported enrollment target (69% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Constipation
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04534036's enrollment target sits among peer trials
64 28th of 54 higher than 27 of 54 other Constipation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Constipation trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Optimization of Postoperative Bowel Habits
RECRUITING · NA
-
Management of Dyssynergic Defecation
RECRUITING · NA
-
Interrogating the Pathophysiological Mechanisms of Constipation in Patients With Systemic Sclerosis
RECRUITING · NA
-
Fecobionics in Biofeedback Therapy in Dyssynergia Patients
RECRUITING · NA
-
Understanding Mechanisms of Normal and Disordered Defecation
RECRUITING · NA
-
Impact of Weizmannia (Bacillus) Coagulans JBI-YZ6.3 on Gut Health and Fecal Microbiome Changes
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01853631 · 64 participants · Phase 1
Activated T-Cells Expressing 2nd or 3rd Generation CD19-Specific CAR, Advanced B-Cell NHL, ALL, and CLL (SAGAN)
- NCT03739502 · 64 participants · Phase 2
A Randomized Phase II Study of Hyperbaric Oxygen in Improving Engraftment in Umbilical Cord Blood Stem Cell Transplant
- NCT03739814 · 64 participants · Phase 2
Inotuzumab Ozogamicin and Blinatumomab With or Without Ponatinib in Treating Patients With Newly Diagnosed, Recurrent, or Refractory CD22-Positive B-Lineage Acute Lymphoblastic Leukemia
- NCT03866408 · 64 participants · Early Phase 1
Insulin Regulation of Lipolysis and Lipolysis Proteins
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI