Intestinal Microbiota Composition in Patients With Chronic Pancreatitis and Pancreatic Exocrine Insufficiency
NCT ID: NCT05132309
Last Updated: 2021-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
96 participants
OBSERVATIONAL
2020-11-01
2021-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Chronic pancreatitis without pancreatic external insufficiency
enzyme replacement therapy
Correction of the previously prescribed dose of enzyme replacement therapy (ERT)/first time selection of ERT according to the severity of pancreatic exocrine insufficiency
Chronic pancreatitis with mild pancreatic external insufficiency
enzyme replacement therapy
Correction of the previously prescribed dose of enzyme replacement therapy (ERT)/first time selection of ERT according to the severity of pancreatic exocrine insufficiency
Chronic pancreatitis with severe pancreatic external insufficiency
enzyme replacement therapy
Correction of the previously prescribed dose of enzyme replacement therapy (ERT)/first time selection of ERT according to the severity of pancreatic exocrine insufficiency
Chronic pancreatitis with severe pancreatic external insufficiency who underwent pancreatic surger
enzyme replacement therapy
Correction of the previously prescribed dose of enzyme replacement therapy (ERT)/first time selection of ERT according to the severity of pancreatic exocrine insufficiency
Interventions
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enzyme replacement therapy
Correction of the previously prescribed dose of enzyme replacement therapy (ERT)/first time selection of ERT according to the severity of pancreatic exocrine insufficiency
Eligibility Criteria
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Inclusion Criteria
* Chronic pancreatitis etiology: idiopathic, biliary dependent, drug-induced, alcoholic, dysmetabolic, CP as a consequence of recurrent and severe acute pancreatitis (postnecrotic);
* History of confirming diagnostic criteria of CP (in accordance with 1) Clinical guidelines of the Russian Gastroenterological Association on the diagnosis and treatment of exocrine pancreatic insufficiency 2018; 2) Clinical guidelines of the unified European guidelines for gastroenterology, on the diagnosis and therapy of chronic pancreatitis 2017; 3) Clinical guidelines of the American College of Gastroenterology 2020);
* CP diagnosis according to multispiral computed tomography of the abdominal cavity and/or endoscopic ultrasonography of pancreas: size changes; dilatation of the main pancreatic duct more than 2 mm; increased echogenicity of the walls, uneven contours and heterogeneity of the BP parenchyma, concrements or calcification of the parenchyma;
* Clinical manifestations of exocrine insufficiency of pancreas: stool disorders (mushy/liquid stool, number of defecation acts \>3 p/day, undigested food remains), steatorrhea, abdominal distention, nausea/vomiting, weight loss progression with adequate caloric intake and no other objective reasons of weight loss;
* Fecal elastase-1 values less than 200 µg/g (for CP groups with EPI) or more than 200 µg/g (for CP group without concomitant EPI);
* Informed patient consent to participate in the study.
Exclusion Criteria
* Hepatitis, cirrhosis of any etiology;
* Any acid-dependent diseases requiring immediate or long-term proton pump inhibitor therapy (PPI): gastroesophageal reflux disease, acute gastroduodenal erosions of any etiology; Zollinger-Ellison syndrome, etc;
* Stenosis of pylorys or duodenum;
* Condition after gastric resection or gastrectomy;
* Obstructive and autoimmune CP;
* Mesenteric ischemia syndrome;
* Any other cause of chronic diarrhea (irritable bowel syndrome with diarrhea predominance, gluten enteropathy, lactase deficiency, inflammatory bowel disease, etc.);
* Concomitant administration of drugs directly affecting exocrine pancreatic secretion (octreotide);
* Any concomitant diseases in the stage of decompensation (cardiovascular, renal failure, diabetes mellitus, etc.);
* Chronic infectious diseases requiring constant (long-term) supportive therapy, including HIV infection, etc;
* Hypersensitivity to pancreatin;
* Use of pro-, pre-, synbiotics, week prior to inclusion in this study;
* Use of antibiotics within 4 weeks prior to inclusion in this study;
* Pregnancy and lactation;
* Use of prohibited concomitant therapy during the study: pro-, pre-, synbiotics, including dietary fiber preparations and lactulose, as well as antibiotics, intestinal antiseptics, loperamide, intestinal sorbents.
23 Years
80 Years
ALL
No
Sponsors
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Moscow State University of Medicine and Dentistry
OTHER
Federal Research and Clinical Center of Physical-Chemical Medicine
OTHER
Responsible Party
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Principal Investigators
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Elena Ilina, Prof
Role: STUDY_DIRECTOR
Federal Research and Clinical Center of Physical-Chemical Medicine
Igor Maev, Prof
Role: STUDY_DIRECTOR
Moscow State University of Medicine and Dentistry
Locations
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Federal Research and Clinical Center of Physical-Chemical Medicine, Moscow (FRCC PCM)
Moscow, , Russia
Moscow State University of Medicine and Dentistry
Moscow, , Russia
Countries
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Other Identifiers
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CP-2021
Identifier Type: -
Identifier Source: org_study_id