Clinical trial NCT04449887: The Role of Intestinal Flora in the Pathogenesis of FD and the Intervention of Xiangsha Liujunzi
Official title: The Role of Intestinal Flora in the Pathogenesis of FD and the Intervention of Xiangsha Liujunzi
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Functional Dyspepsia
Keywords: xiangshaliujunzi,functional dyspepsia，Intestinal flora
Lead sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2020-06-29
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief 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 Criteria:

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

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.

Primary outcomes:
measure: General impression scale
timeFrame: 4 weeks
measure: Symptom severity scale
timeFrame: 4 weeks
Secondary outcomes:
measure: SF-36 scale
timeFrame: 4 weeks
measure: TCM symptom score (TCMSS)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Digestive department of Xi Yuan Hospital of China Academy of Chinese Medical Sciences
state: Beijing
Study officials:
References: