Intestinal Microbiota Composition in Patients With Chronic Pancreatitis and Pancreatic Exocrine Insufficiency

NCT05132309 | Completed

• 1 other identifier: CP-2021
• Study Type: observational
• Target: 96
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Chronic Pancreatitis; Pancreatic Exocrine Insufficiency

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (4)

Chronic pancreatitis without pancreatic external insufficiency

Combination Product: enzyme replacement therapy

Chronic pancreatitis with mild pancreatic external insufficiency

Combination Product: enzyme replacement therapy

Chronic pancreatitis with severe pancreatic external insufficiency

Combination Product: enzyme replacement therapy

Chronic pancreatitis with severe pancreatic external insufficiency who underwent pancreatic surger

Combination Product: enzyme replacement therapy

Interventions

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

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; Chronic pancreatitis without pancreatic external insufficiency

Eligibility Criteria

• Age: 23 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

primary care clinic

You may qualify if:

• Age 18 to 80 years old; any gender;
• 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.

You may not qualify if:

• Acute pancreatitis;
• 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;
• 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.

Sponsors & Collaborators

• Federal Research and Clinical Center of Physical-Chemical Medicine: lead
• Moscow State University of Medicine and Dentistry: collaborator

Study Sites (2)

Federal Research and Clinical Center of Physical-Chemical Medicine, Moscow (FRCC PCM)

Moscow, 117312, Russia

Location

Moscow State University of Medicine and Dentistry

Moscow, 127473, Russia

Location

MeSH Terms

Conditions

Pancreatitis, Chronic; Exocrine Pancreatic Insufficiency

Interventions

Enzyme Replacement Therapy

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Enzyme Therapy; Drug Therapy; Therapeutics

Study Officials

• 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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2021
• First Posted: November 24, 2021
• Study Start: November 1, 2020
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: November 24, 2021

Record last verified: 2021-08

Locations

RU (2)