Effect of Gastrogenic Microbiota in FD

Nanfang Hospital, Southern Medical University

Status

Completed

Conditions

Dysbiosis

Dyspepsia

Treatments

Other: Placebo

Dietary Supplement: Gastrogenic Microbiota

Study type

Interventional

Funder types

Other

Identifiers

NCT06760897

NFEC-2024-670

Details and patient eligibility

About

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

Full 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).

Enrollment

74 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.