Functional DyspepsiaNCT06326918
Duodenal Microbiota in Functional Dyspepsia
An observational study of Functional Dyspepsia, run by King Chulalongkorn Memorial Hospital at 1 site in Thailand.
Trial summary
The goal of this observational study is to assess the type of duodenal microbiota and duodenal microbiome in in FD patients compared to control group. The main questions it aims to answer are: What are the differences in the type of duodenal microbiota and is there a difference in duodenal microbiome diversity between… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Functional Dyspepsia
- What is being tested?
- Duodenal mucosal brushing and Duodenal mucosal biopsy
- How many people
- 40 participants
- Where
- 1 siteThailand
- Study dates
- 12 Feb 2024to 30 Jun 2025
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants who were diagnosed with functional dyspepsia according to the ROME IV criteria at King Chulalongkorn Memorial Hospital.
Who may be able to join
- Functional dyspepsia group 1.1 Patients who are 18 years old or more and exhibit at least one of the following four symptoms for the last 3 months, with symptom onset occurring at least 6 months prior to diagnosis.
- 1.1.1 Postprandial distress syndrome (symptoms occurring at least 3 days per week), including:
- Postprandial fullness and/or
- Early satiation 1.1.2 Epigastric pain syndrome (symptoms occurring at least 1 day per week), including:
- Epigastric pain and/or
- Epigastric burning 1.2 Participants undergo esophago-gastro duodenoscopy (EGD) to confirm the absence of any structural abnormalities.
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- Control group
- Patients with no or minimal upper GI symptoms (not match the criteria of FD) and current EGD appear normal or insignificant gastritis
- Age- and sex-matched to the functional dyspepsia (FD) patient group.
Who cannot join
- Participants with known organic causes of dyspepsia, including peptic ulcers, gastrointestinal malignancies, or inflammatory bowel disease
- Participants with a history of gastric or hepatobiliary surgery
- Participants who have taken antibiotics and probiotics (as supplements) within 4 weeks before the study
- Participants with significant systemic illnesses, including severe liver or kidney disease, immunodeficiency disorders, or autoimmune diseases
- Pregnant or breastfeeding participants
- Participants who are unable or unwilling to undergo endoscopic procedures for duodenal mucosa collection
- Participants who have taken PPI within 2 weeks before the study
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
King Chulalongkorn Memorial Hospital
Bangkok, 10330
Rapat Pittayanon, MD, +66813132112, rapat125@gmail.com
Chatpol Samuthpongtorn, MD, +66813462108, csamuthpongtorn@gmail.com
About this study
Official title: The Difference of Duodenal Microbiota Between Patients With Functional Dyspepsia and Control: a Pilot Study
The goal of this observational study is to assess the type of duodenal microbiota and duodenal microbiome in in FD patients compared to control group. The main questions it aims to answer are:
- What are the differences in the type of duodenal microbiota and is there a difference in duodenal microbiome diversity between patients diagnosed with functional dyspepsia (FD) and the control group?
- Are there any significant variations in the composition and diversity of gut microbiota between patients with FD and the control group, considering the method of sample collection (duodenal brushing vs. duodenal biopsy)?
Read the detailed description
Dyspepsia, a common GI disorder, affects a significant portion of the global population, with a prevalence as high as 66% in Thailand. Functional dyspepsia (FD) is characterized by no detectable structural abnormalities during endoscopic examinations and significantly impacts health-related quality of life. Dysregulation of the gut-brain axis is hypothesized to contribute to motility disorders, visceral hypersensitivity, and mucosal/immune function changes in FD.
Recent studies have characterized the microbiota of the duodenal mucosal-associated microbiome (MAM) in patients with functional dyspepsia (FD). However, duodenal microbiota in FD patients compared to healthy control remains unclear with conflicting results. The number of studies evaluating this is limited, and a well-designed study comparing the duodenal microbiota of patients with functional dyspepsia to control group will advance our understanding of the potential role of the microbiome in FD. Therefore, the aim of this study is to compare the duodenal microbiota of patients with FD and those without upper GI symptoms.
This study is pilot phase, cross-sectional and case-control study that aims to evaluate microbiota profile in patients with functional dyspepsia, compared to those without functional dyspepsia by using mucosal brush sampling and mucosal biopsy sampling.
Study protocol include Age, gender, BMI, smoking history, history of PPI use within 2 weeks, history of antibiotic use within 4 weeks, history of probiotic use within 4 weeks will be recorded in case record form.
After consent, standard EGD will be performed. The duodenal mucosa using mucosal brushing with sterile sheathed brush, duodenal mucosal biopsy by standard forceps biopsy will be done respectively. ㆍ The duodenal mucosal specimen will be keep in sterile tube and immediate keep in freezing at -80C (allow room temperature <2 hr) for 16sRNA sequencing analysis.
- Conditions
- Functional Dyspepsia
- Being tested
- Duodenal mucosal brushing, Duodenal mucosal biopsy
- Keywords
- Duodenal microbiota, Gut microbiome, Functional dyspepsia, Next generation sequencing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Duodenal mucosal brushingDiagnostic test
Duodenal mucosal brushing will be performed at duodenal bulb.
Duodenal mucosal biopsyDiagnostic test
Duodenal mucosal biopsy will be performed at duodenal bulb.
| Study group | Role | What they receive |
|---|---|---|
| Functional dyspepsia | 1. Patients who are 18 years old or more and exhibit at least one of the following four symptoms for the last 3 months, with symptom onset occurring at least 6 months prior to diagnosis.
1.1 Postprandial distress syndrome (symptoms occurring at least 3 days per week), including:
* Postprandial fullness and/or
* Early satiation
1.2 Epigastric pain syndrome (symptoms occurring at least 1 day per week), including:
* Epigastric pain and/or
* Epigastric burning
2. Participants undergo esophago-gastro duodenoscopy (EGD) to confirm the absence of any structural abnormalities. Receives: Diagnostic Test: Duodenal mucosal brushing; Diagnostic Test: Duodenal mucosal biopsy | |
| Control | * Patients with no or minimal upper GI symptoms (not match the criteria of FD) and current EGD appear normal or insignificant gastritis
* Age- and sex-matched to the functional dyspepsia (FD) patient group. Receives: Diagnostic Test: Duodenal mucosal brushing; Diagnostic Test: Duodenal mucosal biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specific microbial genus using mucosal brushing
The difference of specific duodenal microbiota between patients with functional dyspepsia (FD) and control.
Measured: Through study completion, estimated 1.5 years
Microbiome diversity using mucosal brushing
The difference of specific duodenal microbiome diversity between patients with functional dyspepsia (FD) and control.
Measured: Through study completion, estimated 1.5 years
Secondary outcomes (2)
Specific microbial genus using mucosal biopsy
The difference of specific duodenal microbiota between patients with functional dyspepsia (FD) and control.
Measured: Through study completion, estimated 1.5 years
Microbiome diversity using mucosal biopsy
The difference of specific duodenal microbiome diversity between patients with functional dyspepsia (FD) and control.
Measured: Through study completion, estimated 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start12 Feb 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Functional DyspepsiaStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Chulalongkorn Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rapat Pittayanon, King Chulalongkorn Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06326918
- Sponsor's protocol ID
- RP026
- Status last verified
- Mar 2024
- First submitted
- 18 Mar 2024
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Samuthpongtorn C, Vimonsuntirungsri T, Tangkijvanich P, Pittayanon R. Comparative pilot study using mucosal brushing and mucosal biopsy for detecting duodenal microbiome in functional dyspepsia. Gut Pathog. 2026 Jul 28;18(1):83. doi: 10.1186/s13099-026-00863-z.
PubMed 42947191
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Difference of Duodenal Microbiota Between Patients With Functional Dyspepsia and Control: a Pilot Study
- ClinicalTrials.gov ID
- NCT06326918
- Acronym / sponsor ID
- RP026
- Conditions
- Functional Dyspepsia
- Keywords
- Duodenal microbiota, Gut microbiome, Functional dyspepsia, Next generation sequencing
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- King Chulalongkorn Memorial HospitalUniversity, hospital or other
- Study start
- 12 Feb 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 22 Mar 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.
The goal of this observational study is to assess the type of duodenal microbiota and duodenal microbiome in in FD patients compared to control group. The main questions it aims to answer are:
- What are the differences in the type of duodenal microbiota and is there a difference in duodenal microbiome diversity between patients diagnosed with functional dyspepsia (FD) and the control group?
- Are there any significant variations in the composition and diversity of gut microbiota between patients with FD and the control group, considering the method of sample collection (duodenal brushing vs. duodenal biopsy)?
Detailed description
Dyspepsia, a common GI disorder, affects a significant portion of the global population, with a prevalence as high as 66% in Thailand. Functional dyspepsia (FD) is characterized by no detectable structural abnormalities during endoscopic examinations and significantly impacts health-related quality of life. Dysregulation of the gut-brain axis is hypothesized to contribute to motility disorders, visceral hypersensitivity, and mucosal/immune function changes in FD.
Recent studies have characterized the microbiota of the duodenal mucosal-associated microbiome (MAM) in patients with functional dyspepsia (FD). However, duodenal microbiota in FD patients compared to healthy control remains unclear with conflicting results. The number of studies evaluating this is limited, and a well-designed study comparing the duodenal microbiota of patients with functional dyspepsia to control group will advance our understanding of the potential role of the microbiome in FD. Therefore, the aim of this study is to compare the duodenal microbiota of patients with FD and those without upper GI symptoms.
This study is pilot phase, cross-sectional and case-control study that aims to evaluate microbiota profile in patients with functional dyspepsia, compared to those without functional dyspepsia by using mucosal brush sampling and mucosal biopsy sampling.
Study protocol include Age, gender, BMI, smoking history, history of PPI use within 2 weeks, history of antibiotic use within 4 weeks, history of probiotic use within 4 weeks will be recorded in case record form.
After consent, standard EGD will be performed. The duodenal mucosa using mucosal brushing with sterile sheathed brush, duodenal mucosal biopsy by standard forceps biopsy will be done respectively. ㆍ The duodenal mucosal specimen will be keep in sterile tube and immediate keep in freezing at -80C (allow room temperature <2 hr) for 16sRNA sequencing analysis.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functional dyspepsia | – | Diagnostic Test: Duodenal mucosal brushing, Diagnostic Test: Duodenal mucosal biopsy1. Patients who are 18 years old or more and exhibit at least one of the following four symptoms for the last 3 months, with symptom onset occurring at least 6 months prior to diagnosis. 1.1 Postprandial distress syndrome (symptoms occurring at least 3 days per week), including: * Postprandial fullness and/or * Early satiation 1.2 Epigastric pain syndrome (symptoms occurring at least 1 day per week), including: * Epigastric pain and/or * Epigastric burning 2. Participants undergo esophago-gastro duodenoscopy (EGD) to confirm the absence of any structural abnormalities. |
| Control | – | Diagnostic Test: Duodenal mucosal brushing, Diagnostic Test: Duodenal mucosal biopsy* Patients with no or minimal upper GI symptoms (not match the criteria of FD) and current EGD appear normal or insignificant gastritis * Age- and sex-matched to the functional dyspepsia (FD) patient group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants who were diagnosed with functional dyspepsia according to the ROME IV criteria at King Chulalongkorn Memorial Hospital.
Key inclusion criteria (9 listed)
- Functional dyspepsia group 1.1 Patients who are 18 years old or more and exhibit at least one of the following four symptoms for the last 3 months, with symptom onset occurring at least 6 months prior to diagnosis.
- 1.1.1 Postprandial distress syndrome (symptoms occurring at least 3 days per week), including:
- Control group
Key exclusion criteria (7 listed)
- Participants with known organic causes of dyspepsia, including peptic ulcers, gastrointestinal malignancies, or inflammatory bowel disease
- Participants with a history of gastric or hepatobiliary surgery
- Participants who have taken antibiotics and probiotics (as supplements) within 4 weeks before the study
- Participants with significant systemic illnesses, including severe liver or kidney disease, immunodeficiency disorders, or autoimmune diseases
- Pregnant or breastfeeding participants
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 |
|---|---|---|
| Duodenal mucosal brushingDuodenal mucosal brushing will be performed at duodenal bulb. | Diagnostic test | Control, Functional dyspepsia |
| Duodenal mucosal biopsyDuodenal mucosal biopsy will be performed at duodenal bulb. | Diagnostic test | Control, Functional dyspepsia |
Primary outcome
Specific microbial genus using mucosal brushing
Time frame: Through study completion, estimated 1.5 years
The difference of specific duodenal microbiota between patients with functional dyspepsia (FD) and control.
Microbiome diversity using mucosal brushing
Time frame: Through study completion, estimated 1.5 years
The difference of specific duodenal microbiome diversity between patients with functional dyspepsia (FD) and control.
2 secondary outcomes
Specific microbial genus using mucosal biopsy
Time frame: Through study completion, estimated 1.5 years
Microbiome diversity using mucosal biopsy
Time frame: Through study completion, estimated 1.5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Derived from this study: PubMed 42947191Samuthpongtorn C, Vimonsuntirungsri T, Tangkijvanich P, Pittayanon R. Comparative pilot study using mucosal brushing and mucosal biopsy for detecting duodenal microbiome in functional dyspepsia. Gut Pathog. 2026 Jul 28;18(1):83. doi: 10.1186/s13099-026-00863-z.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Functional Dyspepsia, run by King Chulalongkorn Memorial Hospital at 1 site in Thailand.
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 9 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 22 Mar 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 Thailand. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chatpol Samuthpongtorn, MD (+66813462108, csamuthpongtorn@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Specific microbial genus using mucosal brushing (time frame: Through study completion, estimated 1.5 years). The study lists 2 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 NCT06326918, which also lists 1 linked publication.
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 22 Mar 2024.