NCT03867591

Fermented Soy and Heartburn Symptom Relief

Completed NA Last updated 9 June 2020

What this trial tests

NA trial testing Gastro-AD® in Heartburn in 51 participants. Completed in 31 December 2019.

Timeline

22 March 2019

Primary endpoint
30 June 2019

31 December 2019

Quick facts

Lead sponsor	University of Florida
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	51
Start date	22 March 2019
Primary completion	30 June 2019
Estimated completion	31 December 2019
Sites	1 location across United States

Drugs / interventions tested

• Gastro-AD®
• Placebo

Conditions studied

• Heartburn — all drugs for Heartburn →
• Acid Regurgitation — all drugs for Acid Regurgitation →

Sponsor

University of Florida

Who can join

Adults 18 to 60, any sex, with Heartburn or Acid Regurgitation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Heartburn is as common gastrointestinal symptom experienced by otherwise healthy adults and typically manifests as a painful burning sensation in the upper abdomen or in the chest. Typically, heartburn symptoms are treated with over-the-counter (OTC) medications which may come with side effects.

There is suggestive evidence of the efficacy of fermented soy (Gastro-AD®) for the heartburn symptom relief. The aim of the study is to evaluate the effect of a fermented soy on heartburn symptom relief and time to onset.

Publications & conference data

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

1. Fermented soy supplementation improves indicators of quality of life: a randomized, placebo-controlled, double-blind trial in adults experiencing heartburn.
   Fatani A, Vaher K, Rivero-Mendoza D, Alabasi K, et al · · 2020 · cited 7× · PMID 32746904 · DOI 10.1186/s13104-020-05205-z