Fermented Soy and Heartburn Symptom Relief

University of Florida

Status: Completed

Conditions: Heartburn; Acid Regurgitation

Treatments: Other: Placebo; Other: Gastro-AD®

Study type: Interventional

Funder types: Other

Identifiers

NCT03867591

IRB201900115 (Other Identifier)

OCR19814

Details and patient eligibility

About

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.

Full 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. Usually it is caused by the regurgitation of gastric acid into the esophagus. The prevalence of heartburn is 10-20% worldwide and is increasing. Typically, heartburn symptoms are treated with over-the-counter (OTC) medications which may come with side effects.

Gastro-AD® is a commercially available food supplement produced by fermentation of soy by a specific strain of Lactobacillus. There is suggestive evidence, in vivo as well as in vitro studies, 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. It is hypothesized that the consumption of 1-3 g of fermented soy will relieve the heartburn symptom severity.

Enrollment: 51 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Able to provide written informed consent in English.
• Willing to have height and weight measured and provide demographic information (e.g. age, race, sex)
• Experience heartburn symptoms at least 2 days a week during the past 3 months.
• Use OTC product(s), supplements, or dietary manipulation to relieve heartburn symptoms in the last 3 months.
• Willing to take the study soy supplement before resorting to OTC product(s) to control heartburn symptoms.
• Willing to complete questionnaires, records, and diaries associated with the study and to complete all clinical visits.
• Willing to provide information about dietary intake; 3-day online 24-hr recalls during baseline, intervention, and washout.
• Willing and able to provide a valid social security for study payment purposes.

Exclusion criteria

• Do not meet the above criteria.
• Soy allergy
• Severe heartburn problem (cannot be ignored and often limits your concentration on daily activities) during the last week
• Diagnosed or currently being treated for any gastrointestinal diseases including GERD, gastric ulcers, Crohn's, celiac, ulcerative colitis, etc.
• Self-disclosed as pregnant or breast-feeding or planning on becoming pregnant during the study duration.
• Currently participating in another clinical study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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51 participants in 2 patient groups, including a placebo group

Gastro-AD® Group

Experimental group

Description:

The participants randomized to this group 1 g of Gastro-AD® powder per sachet + flavoring agents.

Treatment:

Other: Gastro-AD®

Placebo Group

Placebo Comparator group

Description:

Participants in this arm will take a sachet containing maltodextrin (1 g) and exactly the same flavoring and coloring agents as Gastro-AD® powder flavored sachets.

Treatment:

Other: Placebo