Examining duodenal microbiota in patients with functional dyspepsia

The Difference of Duodenal Microbiota Between Patients With Functional Dyspepsia and Control: a Pilot Study

This study is trying to see if the bacteria in the intestines of people with functional dyspepsia are different from those without digestive issues to better understand how it might affect their condition.

Quick facts

• Study type: Observational
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: King Chulalongkorn Memorial Hospital (other)
• Locations: 1 site (Bangkok)
• Trial ID: NCT06326918 on ClinicalTrials.gov

What this trial studies

This observational study aims to compare the duodenal microbiota and microbiome diversity between patients diagnosed with functional dyspepsia (FD) and a control group without upper gastrointestinal symptoms. It will utilize mucosal brushing and biopsy sampling methods to assess differences in microbiota composition. The study seeks to clarify conflicting results from previous research regarding the role of the gut microbiome in FD, which is a common gastrointestinal disorder affecting many individuals. By understanding these differences, the study hopes to shed light on the potential implications of the microbiome in the management of FD.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with a diagnosis of functional dyspepsia exhibiting specific gastrointestinal symptoms.

Not a fit: Patients with known organic causes of dyspepsia or significant upper GI symptoms may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved understanding and management strategies for patients suffering from functional dyspepsia.

How similar studies have performed: While there have been limited studies on duodenal microbiota in functional dyspepsia, this study aims to provide clearer insights, making it a novel approach.

Eligibility criteria

Inclusion Criteria:

1. 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.
2. 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.

Exclusion Criteria:

* 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

Where this trial is running

Bangkok

• King Chulalongkorn Memorial Hospital — Bangkok, Thailand (RECRUITING)

Study contacts

• Study coordinator: Chatpol Samuthpongtorn, MD

Conditions: Functional Dyspepsia, Duodenal microbiota, Gut microbiome, Functional dyspepsia, Next generation sequencing