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NCT05363618
Tolerability Study of Panosyl-Isomaltooligosaccharides (PIMO) and a Placebo in Subjects With Heartburn
NA trial testing Panosyl-isomaltooligosaccharides (PIMO) 1g (1.4 ml) in Heartburn in 211 participants. Completed in 30 May 2023.
30 May 2023
Quick facts
| Lead sponsor | Microbiome Health Sciences |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | other |
| Enrollment | 211 |
| Start date | 10 February 2022 |
| Primary completion | 30 May 2023 |
| Estimated completion | 30 May 2023 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Panosyl-isomaltooligosaccharides (PIMO) 1g (1.4 ml)
- Placebo 1.4 ml
Conditions studied
- Heartburn — all drugs for Heartburn →
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):
-
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:
- PubMed search for NCT05363618
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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- NCT05629143 — Primary carE PPi dEprescRibing Trial · Phase 4 · active not recruiting
- NCT01696734 — Domperidone in Treating Patients With Gastrointestinal Disorders · Phase 3 · recruiting
Other Microbiome Health Sciences trials
Trials by the same sponsor.
- NCT05129618 — Tolerability Study of Panosyl Isomaltooligosaccharides (PIMO), in Subjects With Chronic Idiopathic Constipation (CIC) · 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)
- Trial protocol + status: ClinicalTrials.gov NCT05363618 (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 Microbiome Health Sciences
- Last refreshed: 18 July 2023
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