Effect of Fermented Soybean (FSB) Supplementation on Gas-troesophageal Reflux Disease (GERD)

NCT06524271 | Completed

• 1 other identifier: Nat0001
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

Gastroesophageal reflux disease (GERD) is a prevalent chronic condition affecting the well-being of both adults and children in general medical practice. Research on the effects of fermented soy-bean (FSB) supplementation in managing GERD is relatively new, with limited studies available. Existing research often lacks sufficient dosing regimens and study durations to differentiate be-tween transient placebo effects and sustained benefits. In this study, the beneficial effects of FSB supplementation were investigated in 50 voluntary participants. Participants were required to take 1g of FSB supplement once daily for twelve weeks. GERD symptoms were evaluated using the Reflux Disease Questionnaire (RDQ), while inflammatory markers, including interleukin-4 (IL-4), interleukin-6 (IL-6), and interleukin-8 (IL-8), were measured to assess inflammation. The Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaire was used to evaluate partici-pants' quality of life. Results indicated that FSB supplementation significantly (P\<0.05) alleviated heartburn and regurgitation symptoms and reduced levels of IL-4, IL-6, and IL-8, indicating a notable anti-inflammatory effect. Additionally, significant (P\<0.05) improvements were observed in QOLRAD scores, particularly in vitality, emotional distress, and physical/social functioning. Collectively, our findings support the use of FSB as an adjuvant approach in managing GERD, with notable improvements in patients' quality of life.

Conditions

Gastro Esophageal Reflux

Keywords

Gastroesophageal Reflux Disease (GERD); Reflux Disease Questionnaire (RDQ); inflammatory markers; Quality of Life in Reflux and Dyspepsia (QOLRAD)

Outcome Measures

Primary Outcomes (3)

• Reflux Disease Questionnaire (RDQ)

  The RDQ assessed six symptoms across three domains (heartburn, regurgitation, and upper abdominal pain) using a 6-point Likert scale to measure frequency and severity over the preceding weeks

  4 weeks

• Quality of Life in Reflux and Dyspepsia (QOLRAD)

  This questionnaire comprised 25 questions in five subdomains: emotional distress (questions 12, 14, 15, 17, 19, and 22), sleeping disorders (questions 8, 10, 11, 18, and 21), eating/drinking disorders (questions 3, 5, 9, 13, 16, and 20), physical/social function (questions 2, 6, 23, 24, and 25) and vitality (questions 1, 4, and 7). Participants rated each question on a 7-point Likert scale.

  4 weeks

• Inflammatory Markers

  Three markers were assessed, namely IL-4, IL-6 and IL-8

  4 weeks

Study Arms (2)

Fermented soybean supplementation

EXPERIMENTAL

The intervention supplement composed of Lactobacillus delbrueckii FSB, hydrogen-ated palm kernel oil, sodium caseinate, isolated soy protein, brown rice, inulin, digestive enzymes blend (lactase, protease, cellulase, lipase, amylase, pectinase, papain, and bromelain), galacto-oligosaccharides (GOS), and Bifidobacterium longum, powder form packaged in individual sachets (NattomeTM, Nattome, Kuala Lumpur, Malaysia). The dosage of FSB in each sachet was 1g.

Dietary Supplement: Fermented Soybean

Placebo control

PLACEBO COMPARATOR

The placebo supplement had the exact composition of ingredients but excluding FSB.

Dietary Supplement: Supplement without fermented soybean

Interventions

Fermented Soybean DIETARY_SUPPLEMENT

Same as described earlier

Also known as: Nattome

Fermented soybean supplementation

Supplement without fermented soybean DIETARY_SUPPLEMENT

Same as described earlier

Placebo control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (1) experienced heartburn, acid reflux, regurgitation, or non-cardiac chest pain within the past three months; (2) aged 18 years or older; (3) demonstrated the ability to comprehend the study protocol and information provided by the investigators; and (4) provided in-formed consent.

You may not qualify if:

• \) use of medications related to GERD, such as acid inhibitors, antacids, prokinetics, gastric mucosal protectors, herbs, probiotics, or related preparations within the past two weeks; (2) a history of gastro-esophageal or duodenal surgery; (3) diagnosis of peptic ulcer, gastrointestinal bleeding, esophageal or gastric varices, or upper GI malignancies confirmed by endoscopy at tertiary hospitals; and (4) pregnancy or lactation

Sponsors & Collaborators

• NATTOME SDN BHD: lead
• UCSI University: collaborator

Study Sites (1)

UCSI University

Cheras, Kuala Lumpur, 56000, Malaysia

Location

Related Publications (2)

• Shaw M, Dent J, Beebe T, Junghard O, Wiklund I, Lind T, Johnsson F. The Reflux Disease Questionnaire: a measure for assessment of treatment response in clinical trials. Health Qual Life Outcomes. 2008 Apr 30;6:31. doi: 10.1186/1477-7525-6-31.

  PMID: 18447946 BACKGROUND

• Wiklund IK, Junghard O, Grace E, Talley NJ, Kamm M, Veldhuyzen van Zanten S, Pare P, Chiba N, Leddin DS, Bigard MA, Colin R, Schoenfeld P. Quality of Life in Reflux and Dyspepsia patients. Psychometric documentation of a new disease-specific questionnaire (QOLRAD). Eur J Surg Suppl. 1998;(583):41-9.

  PMID: 10027672 BACKGROUND

MeSH Terms

Conditions

Gastroesophageal Reflux; Dyspepsia

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Same appearance of the supplements given. Identity of participant was masked during examination.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2024
• First Posted: July 29, 2024
• Study Start: November 1, 2023
• Primary Completion: April 30, 2024
• Study Completion: May 31, 2024
• Last Updated: July 29, 2024

Record last verified: 2024-07

Locations

MY (1)