Clinical trial NCT04454996: Study on the Rule and Mechanism of Treating Functional Gastrointestinal Diseases From the Perspective of Liver and Spleen
Official title: Major Achievements in Traditional Chinese Medicine Science and Technology Guidance Projects-Study on the Rule and Mechanism of Treating Functional Gastrointestinal Diseases
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Non-erosive Reflux Disease/Diarrheal Irritable Bowel Syndrome
Lead sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2020-07-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To clarify the changes of intestinal flora - gut - brain axis in FGIDs patients represented by NERD disharmony of liver and stomach and IBS-D disharmony of liver and spleen, and confirm that the imbalance between intestinal flora and host co-metabolism is the key to the pathogenesis of functional gastrointestinal disease. To reveal the common mechanism of regulating liver and spleen (stomach) in treating FGIDs dynamic disorder and visceral hypersensitivity by regulating intestinal flora - intestine - brain axis disorder.


Eligibility criteria: Inclusion Criteria:

1. Healthy volunteers with no abnormal clinical manifestations;
2. Meet the diagnostic criteria of NERD syndrome of disharmony of liver and stomach and IBS-D syndrome of liver depression and spleen deficiency.
3. Aged between 18 and 70.
4. Did not take antibiotics, steroids or other hormones, Chinese herbal preparations (including oral and intravenous administration), microecological preparations or probiotics such as yogurt for nearly a week;
5. Subjects are informed and sign informed consent voluntarily;
6. Have certain reading ability.

Exclusion Criteria:

1. Patients with severe lesions of the heart, liver, kidney and other major organs, hematopoietic system, nervous system or mental diseases;
2. Complicated with other organic diseases of the digestive system (such as peptic ulcer), or systemic diseases that affect the dynamics of the digestive tract (such as hyperthyroidism and diabetes);
3. Ongoing or ongoing use of drugs that may affect gastrointestinal function (antidiarrals, antidepressants, anti-anxiety drugs, intestinal microflora regulation drugs, antibiotics, etc.);
4. Those with a history of allergy to related drugs or severe food allergy used in the research.
5. The body is colonized with metal medical devices. (6) Having a pregnancy plan within three months.

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Primary outcomes:
measure: Changes in 7 point Likert scale scores
timeFrame: Baseline, 2 weeks and 4 weeks during treatment period,4 weeks , 8 weeks , 12 weeks and 16 weeks during follow-up period
measure: Changes in irritable bowel syndrome symptom severity scale scores
timeFrame: Baseline, 2 weeks and 4 weeks during treatment period,4 weeks , 8 weeks , 12 weeks and 16 weeks during follow-up period
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xiyuan Hospital of China Academy of Chinese Medical Science
state: Beijing
Study officials:
References: