Clinical Comparative Study of Precision Flora Transplantation and Standardized Fecal Microbiota Transplantation in Patients With Irritable Bowel Syndrome.
Sponsor study identifier
interventional
70
0 countries
N/A
Study Start
May 20, 2021
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Primary Completion
October 1, 2021
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Study Completion
October 1, 2022
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In order to seek a more precise and convenient treatment, we made a self-made precise transplant capsule that is effective against diarrhea. Compared with standardized fecal microbiota transplantation transplantation on the treat of diarrhea-type irritable bowel syndrome. To observe the similarities and differences of the effect between the two treatment methods on the disease. and the changes in intestinal bacteria was also observed.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 1, 2022
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 5, 2021
Actual (reported)May 18, 2021
Actual (reported)May 20, 2021
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October 1, 2021
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October 1, 2022
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IBS-SSS score
Severity of irritable bowel syndrome.The score varies from 0 to 500. Higher scores suggest more severe condition.
12 Week after treatment
Clinical remission rate
2、4、8、12 Week after treatment
GSRS score
0、2、4、8、12Week after treatment
IBS-QoL score
0、2、4、8、12Week after treatment
PHQ-9
0、2、4、8、12Week after treatment
GAD-7
0、2、4、8、12Week after treatment
Standardized FMT once.Extract all the flora from the feces provided by the donor to make fecal bacteria transplant capsules. The patient took orally on an empty stomach, each time using 3.2g of fecal bacteria.
1.6g Po perday,for 28 days. probiotics that are effective against diarrhea were selected to make precise flora capsules, which are taken when the patient is on an empty stomach, once a day, using 1.6 g of bacteria per day, orally for 28 consecutive days.
The group includes 35 patients. They will receive standardized FMT. Fecal bacteria capsules are used for fecal bacteria transplantation, 16 capsules are used each time, each capsule contains 200mg of fecal bacteria, and it is used orally. It was given only once.
The group includes 35 patients. They will receive Precision Flora Transplantation. They were used self-developed precision transplant capsules for precision flora transplantation. 4 capsules are used each time. Each capsule contains 400mg of various probiotics effective against diarrhea. It is used orally, once a day,for 28 days.
Yanling Wei
Army Medical Center of PLA
First Submitted
May 5, 2021
First Posted
May 18, 2021
Study Start
May 20, 2021
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
October 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 1, 2022
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Last Updated
May 18, 2021
Record last verified: 2021-05
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