Gastro Esophageal RefluxNCT06524271
Effect of Fermented Soybean (FSB) Supplementation on Gas-troesophageal Reflux Disease (GERD)
A study testing Fermented Soybean and Supplement without fermented soybean in people with Gastro Esophageal Reflux, run by NATTOME SDN BHD at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastro Esophageal Reflux
- What is being tested?
- Fermented Soybean and Supplement without fermented soybean
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Nov 2023to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 1) 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Fermented Soybean, Supplement without fermented soybean
- Keywords
- Gastroesophageal Reflux Disease (GERD), Reflux Disease Questionnaire (RDQ), inflammatory markers, Quality of Life in Reflux and Dyspepsia (QOLRAD)
- Medical subject headings
- Gastroesophageal Reflux, Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fermented SoybeanDietary supplement
Also called Nattome
Same as described earlier
Supplement without fermented soybeanDietary supplement
Same as described earlier
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Fermented Soybean |
| Placebo control | Placebo comparator | The placebo supplement had the exact composition of ingredients but excluding FSB. Receives: Dietary Supplement: Supplement without fermented soybean |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 4 weeks
Inflammatory Markers
Three markers were assessed, namely IL-4, IL-6 and IL-8
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start1 Nov 2023
- Primary completion30 Apr 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gastro Esophageal RefluxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- NATTOME SDN BHD
- Sponsor type
- University, hospital or other
- Collaborators
- UCSI University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06524271
- Sponsor's protocol ID
- Nat0001
- Status last verified
- Jul 2024
- First submitted
- 23 Jul 2024
- Last updated
- 29 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request. All of the individual participant data collected during the trial, after deidentification will be shared upon reasonable request. Additional docu-ments including study protocol, statistical analysis plan, informed consent form and clinical study report will also be made available. The data will be available immediately following pub-lication with no end date. Data will be shared with anyone who wishes to access with reasonable request. The data can be used for any types of analyses.
Publications
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.
PubMed 18447946Wiklund 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.
PubMed 10027672
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Fermented Soybean (FSB) Supplementation on Gas-troesophageal Reflux Disease (GERD)
- ClinicalTrials.gov ID
- NCT06524271
- Acronym / sponsor ID
- Nat0001
- Conditions
- Gastro Esophageal Reflux
- Keywords
- Gastroesophageal Reflux Disease (GERD), Reflux Disease Questionnaire (RDQ), inflammatory markers, Quality of Life in Reflux and Dyspepsia (QOLRAD)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- NATTOME SDN BHDUniversity, hospital or other
- Collaborators
- UCSI University
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 29 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fermented soybean supplementation | Experimental | Dietary Supplement: Fermented SoybeanThe 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. |
| Placebo control | Placebo comparator | Dietary Supplement: Supplement without fermented soybeanThe placebo supplement had the exact composition of ingredients but excluding FSB. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 1) 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fermented SoybeanAlso: NattomeSame as described earlier | Dietary supplement | Fermented soybean supplementation |
| Supplement without fermented soybeanSame as described earlier | Dietary supplement | Placebo control |
Primary outcome
Reflux Disease Questionnaire (RDQ)
Time frame: 4 weeks
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
Quality of Life in Reflux and Dyspepsia (QOLRAD)
Time frame: 4 weeks
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.
Inflammatory Markers
Time frame: 4 weeks
Three markers were assessed, namely IL-4, IL-6 and IL-8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
- Background: PubMed 18447946Shaw 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.
- Background: PubMed 10027672Wiklund 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.
- Individual participant dataSharing planned: Undecided. The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request. All of the individual participant data collected during the trial, after deidentification will be shared upon reasonable request. Additional docu-ments including study protocol, statistical analysis plan, informed consent form and clinical study report will also be made available. The data will be available immediately following pub-lication with no end date. Data will be shared with anyone who wishes to access with reasonable request. The data can be used for any types of analyses.
Related trials for Gastro Esophageal Reflux
Not yet recruitingPhase 4
Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
Obese Adults
Recruiting
SPADE Clinical Trial.
Early Gastric Cancer, Adenocarcinoma of the Stomach
Enrolling by invitation
Endoscopic Treatment of Gastroesophageal Reflux Disease
Gastro Esophageal Reflux Disease
Enrolling by invitationObservational study
Assessment of Esophageal Epithelium Integrity With Use of a Novel Mucosal Impedance Device
Gastro Esophageal Reflux
RecruitingObservational study
Efficacy and Safety of Esomeprazole 40 mg IV in Post-Surgical Patients Admitted to the ICU
Stress Ulcers, Reflux Episodes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fermented Soybean and Supplement without fermented soybean in people with Gastro Esophageal Reflux, run by NATTOME SDN BHD at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reflux Disease Questionnaire (RDQ) (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06524271, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2024.