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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.
In order to clarify the effectiveness of precision fecal bacteria transplantation, we have independently developed precision transplantation capsules. Seventy patients with diarrhea-type irritable bowel syndrome were selected and randomly divided into 2 groups. The patients in the first group were treated with standard fecal bacteria transplantation once, and the patients in other group were treated with precision transplantation capsules for 28 days. The clinical symptoms of the patients of the two groups were observed before and 2, 4, 8, 12, 24, and 48 weeks after the treatment, and stool samples were collected for intestinal flora detection. The purpose is to observe and compare the efficacy of the two treatment methods and their influence on the intestinal flora.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FMT group | Active Comparator | 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. |
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| JZ group | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standardized FMT | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical remission rate | Proportion of people in clinical remission after treatment | 2、4、8、12 Week after treatment |
| GSRS score | Gastrointestinal Symptom Rating Scale.The score varies from 16 to 112. Higher scores suggest more severe gastrointestinal pathology. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yanling Wei | Contact | 15310354666 | lingzi016@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Yanling Wei | Army Medical Center of PLA | Principal Investigator |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| D003967 | Diarrhea |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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Diarrhea-type irritable bowel syndrome patients were randomly divided into 2 groups, and each group was given a different treatment method
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The assessor of the scale does not know the grouping of patients when assessing the patient.
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| Precision Flora Transplantation | Combination Product | 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. |
|
| 0、2、4、8、12Week after treatment |
| IBS-QoL score | Quality of life score for IBS patients.The score varies from 0 to 136. Higher scores suggest greater impact of disease on life | 0、2、4、8、12Week after treatment |
| PHQ-9 | Patient Health Questionnaire-9.The score varies from 0 to 27. Higher scores suggest more severe the depression | 0、2、4、8、12Week after treatment |
| GAD-7 | Generalized Anxiety Scale-7.The score varies from 0 to 21. Higher scores suggest heavier the anxiety. | 0、2、4、8、12Week after treatment |
| SAS | Self-rating Anxiety Scale.The score varies from 25 to 100. Higher scores suggest greater degree of anxiety. | 0、2、4、8、12Week after treatment |
| SDS | Self-rating Depression Scale.The score varies from 25 to 100. Higher scores suggest more severe depression. | 0、2、4、8、12after treatment |
| Intestinal flora | Use metagenomics technology to detect intestinal flora | 0、2、4、8、12Week after treatment |
| D004066 | Digestive System Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |