Effect of stomach bacteria on dyspepsia symptoms
The Clinical Efficacy Study of Selective Gastrogenic Microbiota Transplantation in the Treatment of Functional Dyspepsia
NA · Nanfang Hospital, Southern Medical University · NCT06760897
This study is testing whether probiotics from stomach bacteria can help people with functional dyspepsia feel better compared to a placebo.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 68 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Nanfang Hospital, Southern Medical University (other) |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06760897 on ClinicalTrials.gov |
What this trial studies
This interventional study aims to evaluate the impact of probiotics derived from gastric microbiota on patients with functional dyspepsia (FD) who do not have Helicobacter pylori infection. Participants will be randomly assigned to receive either the probiotics or a placebo for eight weeks. Clinical outcomes, tryptophan metabolism, and microbiome parameters will be measured at the start and end of the treatment period to assess the effectiveness of the intervention. The study is designed to provide insights into how gut bacteria influence dyspeptic symptoms and overall gut health.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with functional dyspepsia symptoms and a negative C13 urea breath test.
Not a fit: Patients with a history of significant abdominal surgery, severe organ diseases, or those currently taking certain medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new probiotic treatment option for patients suffering from dyspepsia.
How similar studies have performed: While the specific approach of using gastric-origin probiotics is novel, similar studies have shown promise in using probiotics for gastrointestinal conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults aged ≥18 and ≤70 years, with symptoms such as upper abdominal pain or burning sensation, postprandial bloating, early satiety, etc., and who meet the diagnostic criteria for functional dyspepsia (FD) according to the Rome IV criteria. * Negative result on the C13 urea breath test, and no organic changes observed on gastroscopy. Exclusion Criteria: * Use of acid-suppressing drugs, prokinetic agents, antibiotic or anxiolytics within 4 weeks prior to enrollment. * History of abdominal surgery, abdominal or inflammatory bowel disease, diabetes, active psychiatric disorders, or severe diseases of vital organs such as the heart, lungs, liver, or kidneys. * Pregnant or breastfeeding participants, or those currently involved in other clinical research studies.
Where this trial is running
Guangzhou, Guangdong
- NanfangH — Guangzhou, Guangdong, China (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Dyspepsia, Dysbiosis