Last reviewed · How we verify

NCT05363618

Tolerability Study of Panosyl-Isomaltooligosaccharides (PIMO) and a Placebo in Subjects With Heartburn

Completed NA Last updated 18 July 2023
What this trial tests

NA trial testing Panosyl-isomaltooligosaccharides (PIMO) 1g (1.4 ml) in Heartburn in 211 participants. Completed in 30 May 2023.

Timeline
10 February 2022
Primary endpoint
30 May 2023
30 May 2023

Quick facts

Lead sponsorMicrobiome Health Sciences
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposeother
Enrollment211
Start date10 February 2022
Primary completion30 May 2023
Estimated completion30 May 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Microbiome Health Sciences — full company profile →

Who can join

Adults 18 to 75, any sex, with Heartburn. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Remote un-controlled trial to evaluate the tolerability of MHS-1031 and separately the tolerability of the formulated placebo in subjects with heartburn. Candidates will have heartburn and be taking daily PPIs at up to twice the standard OTC or prescription dosage. Approximately 400 subjects (men and women of all races and ethnicities) will be randomly enrolled in a 1:1 ratio to receive Product or Placebo (1.4 ml) per day.

Publications & conference data

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

  1. Systematic mapping of registered interventional studies addressing the top 10 research priorities in Barrett's oesophagus and gastro-oesophageal reflux disease.
    Gamakaranage C, Ratcliffe E, Britton J, Butler T, et al · · 2025 · PMID 40527525 · DOI 10.1136/bmjgast-2025-001738

Verify or expand the search:

Other recruiting trials for Heartburn

Currently open trials in the same condition.

Other Microbiome Health Sciences trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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/NCT05363618.

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