NCT04534036 (PDS-08™) is a NA clinical trial of PDS-08 in Constipation, sponsored by Seed Health.

Who is sponsoring NCT04534036?

NCT04534036 is sponsored by Seed Health.

What drugs are being tested in NCT04534036?

Interventions in NCT04534036: PDS-08, Placebo.

What condition does NCT04534036 study?

NCT04534036 studies Constipation, Signs and Symptoms, Digestive Signs and Symptoms, Infrequent or Difficult Evacuation.

Is NCT04534036 still recruiting?

NCT04534036 is currently completed. Last updated 25 October 2022.

Last reviewed 2022-10-25 · How we verify

NCT04534036: PDS-08™

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Tolerability and Functional Assessment of a Novel Children's Synbiotic

Completed NA Last updated 25 October 2022

What this trial tests

NA trial testing PDS-08 in Constipation in 64 participants. Completed in 10 February 2022.

Timeline

13 August 2020

Primary endpoint
14 January 2022

10 February 2022

Quick facts

Lead sponsor	Seed Health
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	64
Start date	13 August 2020
Primary completion	14 January 2022
Estimated completion	10 February 2022
Sites	1 location across United States

Drugs / interventions tested

PDS-08
Placebo

Conditions studied

Constipation — all drugs for Constipation →
Signs and Symptoms — all drugs for Signs and Symptoms →
Digestive Signs and Symptoms — all drugs for Digestive Signs and Symptoms →
Infrequent or Difficult Evacuation — all drugs for Infrequent or Difficult Evacuation →

Sponsor

Seed Health

Who can join

Adults 3 to 17, any sex, with Constipation or Signs and Symptoms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Functional response to a microbial synbiotic in the gastrointestinal system of children: a randomized clinical trial.
Tierney BT, Versalovic J, Fasano A, Petrosino JF, et al · · 2023 · cited 10× · PMID 36319696 · DOI 10.1038/s41390-022-02289-0

Verify or expand the search:

Other recruiting trials for Constipation

Currently open trials in the same condition.

NCT07462481 — Probiotic Improve Constipation · NA · recruiting
NCT07466914 — Constipation in Children With Cerebral Palsy · active not recruiting
NCT07215351 — Impact of the Inno Cleanse Dietary Supplement on Gut Health and Associated Variables in Healthy Men and Women · NA · recruiting
NCT07135362 — The Efficacy Evaluation of TCI604 Probiotic on Intestinal Function Improvement · NA · recruiting
NCT07091084 — A Study of Herbal Supplements in Cancer Survivors With Constipation · NA · recruiting

Other Seed Health trials

Trials by the same sponsor.

NCT06236893 — Randomized, Double-Blind Placebo-Controlled Trial to Assess Overall User Experience of a Synbiotic Vaginal Suppository · NA · completed
NCT05659745 — Randomized, Double-blind, Placebo-controlled Trial Investigating the Role of a Personal Care Product on Vaginal Health · NA · completed
NCT04171466 — Metagenomic and Metabolomic Reconstitution of Gut Microbiota After Broad Spectrum Antibiotic Therapy · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04534036 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Seed Health
Last refreshed: 25 October 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04534036.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing