Study on the Rule and Mechanism of Treating Functional Gastrointestinal Diseases From the Perspec… (NCT04454996) | Clinical Trial Compass
UnknownPhase 4
Study on the Rule and Mechanism of Treating Functional Gastrointestinal Diseases From the Perspective of Liver and Spleen
China100 participantsStarted 2020-06-25
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Healthy volunteers with no abnormal clinical manifestations;
✓. Meet the diagnostic criteria of NERD syndrome of disharmony of liver and stomach and IBS-D syndrome of liver depression and spleen deficiency.
✓. Aged between 18 and 70.
✓. 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;
✓. Subjects are informed and sign informed consent voluntarily;
✓. Have certain reading ability.
Exclusion criteria
✕. Patients with severe lesions of the heart, liver, kidney and other major organs, hematopoietic system, nervous system or mental diseases;
✕. 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);
What they're measuring
1
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
2
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
Trial details
NCT IDNCT04454996
SponsorXiyuan Hospital of China Academy of Chinese Medical Sciences
. Ongoing or ongoing use of drugs that may affect gastrointestinal function (antidiarrals, antidepressants, anti-anxiety drugs, intestinal microflora regulation drugs, antibiotics, etc.);
✕. Those with a history of allergy to related drugs or severe food allergy used in the research.
✕. The body is colonized with metal medical devices. (6) Having a pregnancy plan within three months.