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| Name | Class |
|---|---|
| Moscow State University of Medicine and Dentistry | OTHER |
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Assessment of qualitative and quantitative composition of the intestinal microbiota in patients with CP; in patients with CP and PEI complication of mild to severe degree; patients with CP and PEI who underwent surgical intervention on the pancreas. Intergroup comparison of the microbial compositional characteristics and their analysis. Correction of enzyme replacement therapy in selected groups of patients with regard to the identified microbial characteristics. Assessment of the intestinal microbiota composition in dynamics after 6 (+1) months on the background of allocated therapy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chronic pancreatitis without pancreatic external insufficiency |
| ||
| Chronic pancreatitis with mild pancreatic external insufficiency |
| ||
| Chronic pancreatitis with severe pancreatic external insufficiency |
| ||
| Chronic pancreatitis with severe pancreatic external insufficiency who underwent pancreatic surger |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| enzyme replacement therapy | Combination Product | Correction of the previously prescribed dose of enzyme replacement therapy (ERT)/first time selection of ERT according to the severity of pancreatic exocrine insufficiency |
| Measure | Description | Time Frame |
|---|---|---|
| Genetic study of fecal samples of patients with CP | Fecal samples of patients with CP from selected patient groups with/without PEI meet inclusion criteria will undergo 16s rRNA gene sequencing for further comparative intergroup analysis of the obtained data. | 1 week |
| Genetic study of fecal samples of patients with CP | Fecal samples of patients with CP from selected patient groups with/without PEI meet inclusion criteria will undergo 16s rRNA gene sequencing for further comparative intergroup analysis of the obtained data. | 6 months |
| Analysis of intestinal microbiota composition of patients with CP receiving 40,000 units of pancreatin per meal per day | Analysis of intestinal microbiota composition of patients with CP from selected patient groups with/without PEI receiving adequate dosage of enzyme replacement therapy: 40,000 units of pancreatin per meal per day | 6 months |
| Analysis of intestinal microbiota composition of patients with CP receiving inadequate dosage of pancreatin per meal per day | Analysis of intestinal microbiota composition of patients with CP from selected patient groups with/without PEI receiving inadequate dosage of enzyme replacement therapy: (less then adequate dosage) of pancreatin per meal per day | 6 month |
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Inclusion Criteria:
Exclusion Criteria:
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primary care clinic
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| Name | Affiliation | Role |
|---|---|---|
| Elena Ilina, Prof | Federal Research and Clinical Center of Physical-Chemical Medicine | Study Director |
| Igor Maev, Prof | Moscow State University of Medicine and Dentistry | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal Research and Clinical Center of Physical-Chemical Medicine, Moscow (FRCC PCM) | Moscow | 117312 | Russia | |||
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| Moscow State University of Medicine and Dentistry |
| Moscow |
| 127473 |
| Russia |
| ID | Term |
|---|---|
| D050500 | Pancreatitis, Chronic |
| D010188 | Exocrine Pancreatic Insufficiency |
| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D056947 | Enzyme Replacement Therapy |
| ID | Term |
|---|---|
| D057487 | Enzyme Therapy |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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