The Role of Intestinal Flora in the Pathogenesis of FD and the Intervention of Xiangsha Liujunzi

Last updated: June 26, 2020
Sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heartburn (Pediatric)

Functional Dyspepsia

Heartburn

Treatment

N/A

Clinical Study ID

NCT04449887
ZZ13-YQ-006
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

Functional dyspepsia (FD) is a common digestive system disease in clinic. Although it has not reached the level of life-threatening, it seriously affects the quality of life of patients. The pathogenesis of FD mainly involves gastric motility disorder and visceral hypersensitivity. At present, there are gastric motility promoting drugs and gastric acid inhibiting drugs, but they can not achieve satisfactory therapeutic effect. Traditional Chinese medicine has a good clinical effect on FD, but the specific mechanism is not clear. With the gradual deepening of intestinal flora research, it provides a useful tool for elucidating the mechanism of action of traditional Chinese medicine compound. The role of intestinal flora in the pathogenesis of FD, especially in the pathogenesis of symptoms, has not been studied, and the mechanism of Spleen-strengthening and motility-promoting effects of Xiangsha Liujun has not been studied from the perspective of intestinal flora. In this study, 16S rRNA high-throughput sequencing technology was used to observe the difference of intestinal flora between FD patients and normal people, and then to observe the effect of Xiangsha Liujun on intestinal flora of FD patients. The aim of this study was to explore the role of intestinal flora in the pathogenesis of FD and to elucidate the therapeutic mechanism of Xiangsha Liujunzi by regulating intestinal flora of FD patients, so as to provide support for follow-up clinical and experimental studies.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Clinical diagnosis of functional dyspepsia by Rome IV . ② Clinical diagnosis of spleendeficiency and qi stagnation by CTM. ③ Must be able to swallow potion.

Exclusion

Exclusion Criteria:

  • Gastric ulcer

  • Duodenal ulcer.

  • Gastroesophageal reflux disease .

  • Chronic gastritis with HP (+).

  • Chronic pancreatitis.

  • Diabetes.

  • Chronic renal insufficiency.

  • Hematological disease.

  • tumor or AIDS.

  • Pregnant or lactating women.

Study Design

Total Participants: 90
Study Start date:
July 07, 2020
Estimated Completion Date:
August 30, 2022

Connect with a study center

  • Digestive department of Xi Yuan Hospital of China Academy of Chinese Medical Sciences

    Beijing, Beijing 100091
    China

    Active - Recruiting

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