NCT06760897

Effect of Gastrogenic Microbiota in FD

The Clinical Efficacy Study of Selective Gastrogenic Microbiota Transplantation in the Treatment of Functional Dyspepsia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Nanfang Hospital, Southern Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Dyspepsia
• Dysbiosis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Gastrogenic Microbiota	Take 1 sachet of gastric-origin probiotic powder (containing 5 x 1011 CFU per sachet) twice daily for 8 weeks.
OTHER	Placebo	similar powder administered twice daily

Timeline

• Start date: 2024-12-31
• Primary completion: 2025-11-28
• Completion: 2025-12-31
• First posted: 2025-01-07
• Last updated: 2026-01-05

Locations

1 site across 1 country: China