Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03867591
Other study ID # OCR19814
Secondary ID IRB201900115
Status Completed
Phase N/A
First received
Last updated
Start date March 22, 2019
Est. completion date December 31, 2019

Study information

Verified date June 2020
Source University of Florida
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 51
Est. completion date December 31, 2019
Est. primary completion date June 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Gastro-AD®
The product under study is Gastro-AD® fermented soy powder in the form of orodispersible flavored powder packed in non-transparent sachets. Content: 1 g of Gastro-AD® powder per sachet + flavoring agents.
Placebo
The placebo product will have very similar appearance, color, texture and taste as the Gastro-AD® flavored sachet. The placebo sachets contain the respective amount of maltodextrin (1 g) and exactly the same flavoring and coloring agents as Gastro-AD® powder flavored sachets.

Locations

Country Name City State
United States Food Science and Human Nutrition Department Gainesville Florida

Sponsors (2)

Lead Sponsor Collaborator
University of Florida Lallemand Bio-Ingredients

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in severity of heartburn symptoms Severity on a 5-point Likert scale ranging from 1 = no symptoms to 5 = severe discomfort 5 minutes, 15 minutes, 30 minutes
Secondary Change in Gastrointestinal Symptom Rating Scale (GSRS) The GSRS is a disease-specific instrument of 15 items combined into five symptom clusters depicting Reflux, Abdominal pain, Indigestion, Diarrhoea and Constipation. The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms. Baseline; Week 4; Week 5
Secondary Change in Quality of Life (GERD-QOL) The GERD-QOL is disease-specific instrument of 16 items combined into domains. Baseline; Week 4; Week 5
Secondary Heartburn event frequency Heartburn events per period Baseline; Week 4; Week 5
See also
  Status Clinical Trial Phase
Recruiting NCT06094062 - Smartphone App-assisted PPI N/A
Completed NCT00481949 - Assessment of Gastro-esophageal Reflux Using Endo-Flip vs Bravo N/A
Completed NCT04560595 - Remote Guided Caffeine Reduction N/A
Recruiting NCT01696734 - Domperidone in Treating Patients With Gastrointestinal Disorders Phase 3
Recruiting NCT02105090 - Efficacy Study of Articaine Lozenge to Enhance the Procedural Compliance of the Adults Undergoing Gastroduodenoscopy Phase 4
Completed NCT01338077 - Efficacy and Safety of Sodium Alginate Oral Suspension to Treat Non-erosive Gastro-esophageal Reflux Disease Phase 3
Completed NCT01005251 - Investigate the Effect of Different Doses of Lesogaberan (AZD3355) as add-on to PPI in GERD Patients With Partial Response to PPI Phase 2
Terminated NCT00536328 - What is the Predictive Value of the Reflux Impact Scale N/A
Completed NCT00382577 - Efficacy and Safety of Itopride vs Placebo in Heartburn Phase 3
Completed NCT00236197 - E3810-A001-312: Efficacy and Safety of 10 mg Rabeprazole for Treating Heartburn in Frequent Sufferers Phase 3
Completed NCT00236184 - E3810-A001-313: Efficacy and Safety of 10 mg Rabeprazole for Treating Heartburn in Frequent Sufferers Phase 3
Completed NCT00236392 - A Study of Efficacy and Safety of "On-demand" Maintenance Therapy With Rabeprazole in Patients With Non-erosive Reflux Disease (NERD) Phase 3
Completed NCT04153552 - Upset Stomach Relief for Mild and Moderate Indigestion and Heartburn N/A
Recruiting NCT06075082 - The Effect of the LEFT Smartwatch App as Sleep Positional Therapy for Nocturnal Gastroesophageal Reflux Symptoms. N/A
Completed NCT05247333 - Implementation of a Minor Ailment Service in Community Pharmacy Practice N/A
Recruiting NCT02277886 - Esomeprazole Plus Alginate vs. Esomeprazole Alone for Treatment of Nighttime Reflux Symptom and Sleep Disturbances Phase 4
Completed NCT01249651 - To Assess the Efficacy of Esomeprazole 40 mg Once Daily in Subjects Who Still Had Heartburn After Receiving Rabeprazole Phase 4
Completed NCT00588939 - Confocal Laser Microscopy in Non Erosive Reflux Disease N/A
Completed NCT00206024 - Acid-Associated Heartburn Symptoms and Dose of Esomeprazole Phase 4
Recruiting NCT05976165 - A Study of Breath Testing for Small Intestinal Bacterial Overgrowth N/A