DyspepsiaNCT06760897
Effect of Gastrogenic Microbiota in FD
A study testing Gastrogenic Microbiota in people with Dyspepsia and Dysbiosis, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
Single-center prospective interventional study aimed at demonstrating the effect of gastric-origin probiotics on dyspeptic symptoms, tryptophan metabolism, and microbiome parameters in FD patients without Helicobacter pylori infection, compared to a placebo group Read more about this study
- Who is it for?
- Ages 18 to 70 years
- What is being tested?
- Gastrogenic Microbiota
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2024to 31 Dec 2025
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Clinical Efficacy Study of Selective Gastrogenic Microbiota Transplantation in the Treatment of Functional Dyspepsia
Single-center prospective interventional study aimed at demonstrating the effect of gastric-origin probiotics on dyspeptic symptoms, tryptophan metabolism, and microbiome parameters in FD patients without Helicobacter pylori infection, compared to a placebo group
Read the detailed description
Prospective randomized placebo-controlled study in 2 parallel FD cohorts (8 weeks) :
cohort 1FD : Receiving 8 weeks of Gastrogenic Microbiota cohort 2FD : Receiving 8 weeks of placebo Clinical outcomes and Tryptophan metabolism, Microbiome parameters will be assessed at the beginning and end of each treatment period (week 0, 8).
- Being tested
- Gastrogenic Microbiota, Placebo
- Medical subject headings
- Dyspepsia, Dysbiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastrogenic MicrobiotaDietary supplement
Take 1 sachet of gastric-origin probiotic powder (containing 5 x 1011 CFU per sachet) twice daily for 8 weeks.
PlaceboOther
similar powder administered twice daily
| Study group | Role | What they receive |
|---|---|---|
| cohort 1FD | Experimental | Receiving 8 weeks of Gastrogenic Microbiota Receives: Dietary Supplement: Gastrogenic Microbiota |
| cohort 2FD | Placebo comparator | Receiving 8 weeks of placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of relief of functional dyspepsia symptoms in Lactobacillus vs. placebo
The rate of relief of functional dyspepsia symptoms in Lactobacillus vs. placebo [Time Frame: 8 weeks] (using the the Patient Assessment of Upper Gastrointestinal Symptom Severity Index PAGI-SYM).The PAGI-SYM scale is specifically developed for the assessment of functional upper gastrointestinal diseases and is used to evaluate the severity of symptoms associated with these diseases. The scale comprises 21 symptoms of functional upper gastrointestinal diseases, with each symptom rated on a scale from none to very severe, scored as 0, 1, 2, 3, 4, or 5, respectively. The total score is calculated and used to assess the severity of functional upper gastrointestinal diseases.
Measured: 8 weeks
Secondary outcomes (7)
Changes in the Clinical Rating Scale for The Gastrointestinal Symptoms Rating Scale (GSRS) scores in the Lactobacillus vs. the placebo.
The Gastrointestinal Symptom Rating Scale (GSRS) is specifically designed for the assessment of gastrointestinal symptoms, particularly in patients with gastroesophageal reflux disease. This scale consists of a series of questions aimed at evaluating the severity of various gastrointestinal symptoms experienced by the patient over the past week. The GSRS includes items such as pain or discomfort in the upper abdomen, heartburn, and acid reflux, each rated on a scale from 'no discomfort at all' to 'very severe discomfort'. The ratings are scored on a seven-point Likert scale, ranging from 0 to 6, with higher scores indicating more severe symptoms. The total score is calculated by summing the scores of all items, providing a comprehensive assessment of the patient's gastrointestinal symptom severity.
Measured: 8 weeks
Changes in the Quality of Life scores (PAGI-QOL) in the Lactobacillus vs. the placebo.
The Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life (PAGI-QOL) is specifically designed to assess the quality of life in patients with upper gastrointestinal disorders, including dyspepsia, gastroesophageal reflux disease (GERD), and gastroparesis. This questionnaire consists of 30 items covering five domains: Daily Activities, Clothing, Diet and Food Habits, Relationship, and Psychological Well-Being and Distress. Each item is scored to reflect the impact of the disorder on the patient's quality of life, with higher scores indicating a greater impact. The PAGI-QOL has demonstrated excellent internal consistency, with a Cronbach's alpha ranging from 0.83 to 0.96, ensuring its reliability and validity in assessing the quality of life in these patients.
Measured: 8 weeks
Changes in the Self-Rating Anxiety Scale (SAS) scores in the Lactobacillus vs. the placebo.
The Self-Rating Anxiety Scale (SAS) is a widely-used psychological assessment tool, developed by Dr. William W. K. Zung, specifically designed to quantify the level of anxiety in individuals. The SAS is structured to assess various dimensions of anxiety, including cognitive, affective, somatic, and autonomic symptoms, providing a comprehensive overview of an individual's anxiety level. This scale consists of 20 items, each scored on a four-point scale ranging from 1 (none or some of the time) to 4 (most or all of the time), with a total score ranging from 20 to 80, with higher scores indicating more severe anxiety symptoms. The items are phrased to reflect common experiences of people with anxiety, making it a practical tool for both clinical and research settings. It is primarily used to evaluate the presence and intensity of anxiety symptoms, serving as a valuable instrument in the assessment and monitoring of anxiety disorders.
Measured: 8 weeks
Changes in the Self-Rating Depression Scale (SDS) scores in the Lactobacillus vs. the placebo.
The Self-Rating Depression Scale (SDS) is a widely-used psychological assessment tool developed by Dr. William W. K. Zung, designed to measure the presence and severity of depressive symptoms in individuals. This scale consists of 20 items, each assigned a rating on a scale from 1 (none or some of the time) to 4 (most or all of the time), with a total score ranging from 20 to 80, with higher scores indicating more severe depressive symptoms. The SDS is designed to measure the affective, psychological, and somatic aspects of depression, enabling clinicians to better understand and diagnose the condition in their patients. The SDS is a valuable tool in clinical and research settings for assessing depression and its associated factors across diverse populations. Its simple structure and straightforward administration make it an accessible and effective method for measuring depressive symptoms.
Measured: 8 weeks
Differences in the composition of gastric mucosal and fecal microbiota before and after treatment in the probiotic group
Differences in the composition of gastric mucosal and fecal microbiota before and after treatment in the probiotic group
Measured: 8 weeks
Differences in serum and urine neurotransmitters before and after treatment in the probiotic group
Differences in serum and urine neurotransmitters before and after treatment in the probiotic group
Measured: 8 weeks
Safety of Lactobacillus vs. placebo
number of adverse events with sporebiotics vs. placebo
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start31 Dec 2024
- Primary completion28 Nov 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspepsiaStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- 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
- Model description
- randomized placebo-controlled study in 2 parallel FD cohorts
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06760897
- Sponsor's protocol ID
- NFEC-2024-670
- Status last verified
- Dec 2025
- First submitted
- 30 Dec 2024
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Efficacy Study of Selective Gastrogenic Microbiota Transplantation in the Treatment of Functional Dyspepsia
- ClinicalTrials.gov ID
- NCT06760897
- Acronym / sponsor ID
- NFEC-2024-670
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 31 Dec 2024 (actual)
- Primary completion
- 28 Nov 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 7 Jan 2025 (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.
Single-center prospective interventional study aimed at demonstrating the effect of gastric-origin probiotics on dyspeptic symptoms, tryptophan metabolism, and microbiome parameters in FD patients without Helicobacter pylori infection, compared to a placebo group
Detailed description
Prospective randomized placebo-controlled study in 2 parallel FD cohorts (8 weeks) :
cohort 1FD : Receiving 8 weeks of Gastrogenic Microbiota cohort 2FD : Receiving 8 weeks of placebo Clinical outcomes and Tryptophan metabolism, Microbiome parameters will be assessed at the beginning and end of each treatment period (week 0, 8).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- randomized placebo-controlled study in 2 parallel FD cohorts
| Arm | Type | Receives |
|---|---|---|
| cohort 1FD | Experimental | Dietary Supplement: Gastrogenic MicrobiotaReceiving 8 weeks of Gastrogenic Microbiota |
| cohort 2FD | Placebo comparator | Other: PlaceboReceiving 8 weeks of placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Gastrogenic MicrobiotaTake 1 sachet of gastric-origin probiotic powder (containing 5 x 1011 CFU per sachet) twice daily for 8 weeks. | Dietary supplement | cohort 1FD |
| Placebosimilar powder administered twice daily | Other | cohort 2FD |
Primary outcome
The rate of relief of functional dyspepsia symptoms in Lactobacillus vs. placebo
Time frame: 8 weeks
The rate of relief of functional dyspepsia symptoms in Lactobacillus vs. placebo [Time Frame: 8 weeks] (using the the Patient Assessment of Upper Gastrointestinal Symptom Severity Index PAGI-SYM).The PAGI-SYM scale is specifically developed for the assessment of functional upper gastrointestinal diseases and is used to evaluate the severity of symptoms associated with these diseases. The scale comprises 21 symptoms of functional upper gastrointestinal diseases, with each symptom rated on a scale from none to very severe, scored as 0, 1, 2, 3, 4, or 5, respectively. The total score is calculated and used to assess the severity of functional upper gastrointestinal diseases.
7 secondary outcomes
Changes in the Clinical Rating Scale for The Gastrointestinal Symptoms Rating Scale (GSRS) scores in the Lactobacillus vs. the placebo.
Time frame: 8 weeks
Changes in the Quality of Life scores (PAGI-QOL) in the Lactobacillus vs. the placebo.
Time frame: 8 weeks
Changes in the Self-Rating Anxiety Scale (SAS) scores in the Lactobacillus vs. the placebo.
Time frame: 8 weeks
Changes in the Self-Rating Depression Scale (SDS) scores in the Lactobacillus vs. the placebo.
Time frame: 8 weeks
Differences in the composition of gastric mucosal and fecal microbiota before and after treatment in the probiotic group
Time frame: 8 weeks
Differences in serum and urine neurotransmitters before and after treatment in the probiotic group
Time frame: 8 weeks
Safety of Lactobacillus vs. placebo
Time frame: 8 weeks
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 5 Jan 2026.
- Individual participant dataSharing planned: No
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Body Surface Gastric Mapping to Evaluate Patients With Upper Gastrointestinal Symptoms and Controls
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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.
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 Gastrogenic Microbiota in people with Dyspepsia and Dysbiosis, run by Nanfang Hospital, Southern Medical University at 1 site in China.
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 2 inclusion and 3 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 5 Jan 2026. 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 China. 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?
The rate of relief of functional dyspepsia symptoms in Lactobacillus vs. placebo (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jan 2026.