Chronic PancreatitisNCT05132309
Intestinal Microbiota Composition in Patients With Chronic Pancreatitis and Pancreatic Exocrine Insufficiency
An observational study of Chronic Pancreatitis and Pancreatic Exocrine Insufficiency, run by Federal Research and Clinical Center of Physical-Chemical Medicine at 2 sites in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 23 to 80 years
- Conditions the study is for
- Chronic Pancreatitis, Pancreatic Exocrine Insufficiency
- What is being tested?
- enzyme replacement therapy
- How many people
- 96 participants
- Where
- 2 sitesRussia
- Study dates
- 1 Nov 2020to 1 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: primary care clinic
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 16Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
Russia2 sites
Federal Research and Clinical Center of Physical-Chemical Medicine, Moscow (FRCC PCM)
Moscow, 117312
Moscow State University of Medicine and Dentistry
Moscow, 127473
About this study
Official title: Study of Influence of Chronic Pancreatitis Severity Degree With Possible Complication of Pancreatic External Secretory Insufficiency on Intestinal Microbiota Composition Patterns
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
- Being tested
- enzyme replacement therapy
- Medical subject headings
- Pancreatitis, Chronic, Exocrine Pancreatic Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enzyme replacement therapyCombination 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
| Study group | Role | What they receive |
|---|---|---|
| Chronic pancreatitis without pancreatic external insufficiency | Not described Receives: Combination Product: enzyme replacement therapy | |
| Chronic pancreatitis with mild pancreatic external insufficiency | Not described Receives: Combination Product: enzyme replacement therapy | |
| Chronic pancreatitis with severe pancreatic external insufficiency | Not described Receives: Combination Product: enzyme replacement therapy | |
| Chronic pancreatitis with severe pancreatic external insufficiency who underwent pancreatic surger | Not described Receives: Combination Product: enzyme replacement therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start1 Nov 2020
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PancreatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal Research and Clinical Center of Physical-Chemical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Moscow State University of Medicine and Dentistry
- Responsible party
- Sponsor
- Investigators
- Elena Ilina, Prof, Study director, Federal Research and Clinical Center of Physical-Chemical MedicineIgor Maev, Prof, Study director, Moscow State University of Medicine and Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05132309
- Sponsor's protocol ID
- CP-2021
- Status last verified
- Aug 2021
- First submitted
- 30 Jul 2021
- Last updated
- 24 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Influence of Chronic Pancreatitis Severity Degree With Possible Complication of Pancreatic External Secretory Insufficiency on Intestinal Microbiota Composition Patterns
- ClinicalTrials.gov ID
- NCT05132309
- Acronym / sponsor ID
- CP-2021
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Federal Research and Clinical Center of Physical-Chemical MedicineUniversity, hospital or other
- Collaborators
- Moscow State University of Medicine and Dentistry
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 24 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 23 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- primary care clinic
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| enzyme replacement therapyCorrection of the previously prescribed dose of enzyme replacement therapy (ERT)/first time selection of ERT according to the severity of pancreatic exocrine insufficiency | Combination product | 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 |
Primary outcome
Genetic study of fecal samples of patients with CP
Time frame: 1 week
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.
Genetic study of fecal samples of patients with CP
Time frame: 6 months
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.
Analysis of intestinal microbiota composition of patients with CP receiving 40,000 units of pancreatin per meal per day
Time frame: 6 months
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
Analysis of intestinal microbiota composition of patients with CP receiving inadequate dosage of pancreatin per meal per day
Time frame: 6 month
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elena Ilina, Prof study director
Federal Research and Clinical Center of Physical-Chemical Medicine
Igor Maev, Prof study director
Moscow State University of Medicine and Dentistry
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pancreatitis and Pancreatic Exocrine Insufficiency, run by Federal Research and Clinical Center of Physical-Chemical Medicine at 2 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genetic study of fecal samples of patients with CP (time frame: 1 week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2021.