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NCT04491734
Tolerability Study of a Novel Microbiome Therapeutic in Subjects With Gastroesophageal Reflux Disease
NA trial testing maltosyl-isomalto-oligosaccharides (MIMO) in Gastroesophageal Reflux in 156 participants. Completed in 26 August 2021.
26 August 2021
Quick facts
| Lead sponsor | ISOThrive Inc. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 156 |
| Start date | 1 June 2020 |
| Primary completion | 26 August 2021 |
| Estimated completion | 26 August 2021 |
| Sites | 1 location across United States |
Drugs / interventions tested
- maltosyl-isomalto-oligosaccharides (MIMO)
Conditions studied
- Gastroesophageal Reflux — all drugs for Gastroesophageal Reflux →
Sponsor
ISOThrive Inc.
Who can join
Adults 25 to 75, any sex, with Gastroesophageal Reflux. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a remote study. No office visits required. The purpose and efficacy endpoint of this study is to assess whether GERD patients tolerate ISOT-101. In addition, usage of the ReQuest validated questionnaire to measure GERD symptoms will be explored as well as usage of the validated SF-36 quality of life (QoL) questionnaire. Each subject serves as his/her own control. Relative tolerability in subjects both on and off proton pump inhibitors (PPIs) will be compared. Subjects naive to PPIs, currently taking PPIs and historically on PPIs will be evaluated with ReQuest and QoL scores. In addition, survey measurements will be taken on a subset of 10 subjects that are non-responders to PPIs. These will not be included in the statistical analysis with the above groups. A tertiary endpoint of this study is to assess any relevant adverse events that occur.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Gut Microbiome-Brain Alliance: A Landscape View into Mental and Gastrointestinal Health and Disorders.
Sasso JM, Ammar RM, Tenchov R, Lemmel S, et al · · 2023 · cited 100× · PMID 37156006 · DOI 10.1021/acschemneuro.3c00127 -
Role of microbial dysbiosis in the pathogenesis of esophageal mucosal disease: A paradigm shift from acid to bacteria?
D'Souza SM, Houston K, Keenan L, Yoo BS, et al · · 2021 · cited 23× · PMID 34025064 · DOI 10.3748/wjg.v27.i18.2054 -
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 NCT04491734
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Gastroesophageal Reflux
Currently open trials in the same condition.
- NCT07291700 — Study on Hydrotalcite for Relief of Acid Symptoms Due to Acid Rebound After Stopping Long-Term PPI Therapy · recruiting
- NCT06255886 — Treatment of Gastroesophageal Reflux Disease in Infants · Phase 4 · recruiting
- NCT06534359 — Transpyloric Versus Gastric Feeding in Bronchopulmonary Dysplasia · NA · recruiting
- NCT06687603 — Multi-Site Detection of Barrett's Esophagus in Patients Without Chronic GERD Symptoms · NA · recruiting
- NCT06339801 — Role of Mucosal Impedance Measurement for the Diagnosis of Gastroesophageal Reflux Disease · recruiting
Other ISOThrive Inc. trials
Trials by the same sponsor.
- NCT04677634 — Open Label Tolerability Study of ISOThrive Prebiotic Nectar (MIMO) in Subjects With Constipation · 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 NCT04491734 (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 ISOThrive Inc.
- Last refreshed: 30 August 2021
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/NCT04491734.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing