Clinical trial NCT06760897: Effect of Gastrogenic Microbiota in FD
Official title: The Clinical Efficacy Study of Selective Gastrogenic Microbiota Transplantation in the Treatment of Functional Dyspepsia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dyspepsia
Dysbiosis
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2025-01-07
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized placebo-controlled study in 2 parallel FD cohorts
Primary purpose: TREATMENT

Brief 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

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).

Eligibility 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.

Primary outcomes:
measure: The rate of relief of functional dyspepsia symptoms in Lactobacillus vs. placebo
timeFrame: 8 weeks
Secondary outcomes:
measure: Changes in the Clinical Rating Scale for The Gastrointestinal Symptoms Rating Scale (GSRS) scores in the Lactobacillus vs. the placebo.
timeFrame: 8 weeks
measure: Changes in the Quality of Life scores (PAGI-QOL) in the Lactobacillus vs. the placebo.
timeFrame: 8 weeks
measure: Changes in the Self-Rating Anxiety Scale (SAS) scores in the Lactobacillus vs. the placebo.
timeFrame: 8 weeks
measure: Changes in the Self-Rating Depression Scale (SDS) scores in the Lactobacillus vs. the placebo.
timeFrame: 8 weeks
measure: Differences in the composition of gastric mucosal and fecal microbiota before and after treatment in the probiotic group
timeFrame: 8 weeks
measure: Differences in serum and urine neurotransmitters before and after treatment in the probiotic group
timeFrame: 8 weeks
measure: Safety of Lactobacillus vs. placebo
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: NanfangH
state: Guangdong
Study officials:
References: