Acute Pancreatitis Clinical Trial
Official title:
Alteration of Intestinal Microflora and Efficacy and Safety of Fecal Microbiota Transplantation for Severe Acute Pancreatitis
Severe acute pancreatitis is an acute and rapid progress of the digestive system disease.Most patients with severe pancreatitis associated with intestinal mucosal barrier dysfunction.Intestinal microflora,an important part of the intestinal mucosal barrier, play an important role in the development process in the course of severe acute pancreatitis. At this stage of the study that infection of pancreas and other organs is the leading cause of death in patients with severe acute pancreatitis,and the main pathogens from intestinal micro-organisms, but the intestinal flora changes did not be mentioned. Fecal Microbiota Transplantation that has been used for treatment of inflammatory bowel disease and Clostridium difficile infection may be a new technology for regulation of intestinal mucosal dysfunction and intestinal flora unbalance.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | March 2020 |
Est. primary completion date | December 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: 1. The diagnosis of acute pancreatitis: elevated serum amylase and/or lipase levels (more than 3-fold the upper reference limit) and evidence of pancreatitis on computed tomography (CT) of the abdomen; 2. No chronic diseases of the digestive system ; 3. No chronic diseases of the urinary system; 4. No chronic metabolic disease; 5. No chronic disease of immune system 6. No chronic disease of mental disease 7. no acute intestinal disease; taking antibiotics anti-inflammatory drugs and history of probiotics for one month; 8. No use of addictive drugs and immune inhibitors Exclusion Criteria: 1. not to match the standard of AP 2. with chronic diseases of the digestive system; 3. with chronic diseases of the urinary system; 4. with chronic metabolic disease; 5. with chronic disease of immune system 6. with chronic disease of mental disease 7. with acute intestinal disease; taking antibiotics anti-inflammatory drugs and history of probiotics for one month;pregnancy and lactation women 8. with use of addictive drugs and immune inhibitors 9. exceed the age limits |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | IEC of Chengdu Medical College | Chendu |
Lead Sponsor | Collaborator |
---|---|
First Affiliated Hospital of Chengdu Medical College |
China,
Bongaerts GP, Severijnen RS. A reassessment of the PROPATRIA study and its implications for probiotic therapy. Nat Biotechnol. 2016 Jan;34(1):55-63. doi: 10.1038/nbt.3436. — View Citation
Fishman JE, Levy G, Alli V, Zheng X, Mole DJ, Deitch EA. The intestinal mucus layer is a critical component of the gut barrier that is damaged during acute pancreatitis. Shock. 2014 Sep;42(3):264-70. doi: 10.1097/SHK.0000000000000209. — View Citation
Hall JC, Crawford HC. The conspiracy of autophagy, stress and inflammation in acute pancreatitis. Curr Opin Gastroenterol. 2014 Sep;30(5):495-9. doi: 10.1097/MOG.0000000000000097. Review. — View Citation
Hansson GC, Johansson ME. The inner of the two Muc2 mucin-dependent mucus layers in colon is devoid of bacteria. Gut Microbes. 2010 Jan;1(1):51-54. — View Citation
Murphy SF, Rhee L, Grimm WA, Weber CR, Messer JS, Lodolce JP, Chang JE, Bartulis SJ, Nero T, Kukla RA, MacDougall G, Binghay C, Kolodziej LE, Boone DL. Intestinal epithelial expression of TNFAIP3 results in microbial invasion of the inner mucus layer and induces colitis in IL-10-deficient mice. Am J Physiol Gastrointest Liver Physiol. 2014 Nov 1;307(9):G871-82. doi: 10.1152/ajpgi.00020.2014. — View Citation
Noor MT, Radhakrishna Y, Kochhar R, Ray P, Wig JD, Sinha SK, Singh K. Bacteriology of infection in severe acute pancreatitis. JOP. 2011 Jan 5;12(1):19-25. — View Citation
Schwender BJ, Gordon SR, Gardner TB. Risk factors for the development of intra-abdominal fungal infections in acute pancreatitis. Pancreas. 2015 Jul;44(5):805-7. doi: 10.1097/MPA.0000000000000334. — View Citation
Senocak R, Yigit T, Kilbas Z, Coskun AK, Harlak A, Mentes MÖ, Kiliç A, Günal A, Kozak O. The Effects of Total Colectomy on Bacterial Translocation in a Model of Acute Pancreatitis. Indian J Surg. 2015 Dec;77(Suppl 2):412-8. doi: 10.1007/s12262-013-0855-y. — View Citation
Wu LM, Sankaran SJ, Plank LD, Windsor JA, Petrov MS. Meta-analysis of gut barrier dysfunction in patients with acute pancreatitis. Br J Surg. 2014 Dec;101(13):1644-56. doi: 10.1002/bjs.9665. Review. — View Citation
Zhang XP, Zhang J, Song QL, Chen HQ. Mechanism of acute pancreatitis complicated with injury of intestinal mucosa barrier. J Zhejiang Univ Sci B. 2007 Dec;8(12):888-95. doi: 10.1631/jzus.2007.B0888. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mortality | 3 months | Yes | |
Secondary | C-reactive protein(CRP) | 2-4 weeks | No | |
Secondary | Diamine oxidase(DAO) | 2-4 weeks | No | |
Secondary | Interleukin | 2-4 weeks | No | |
Secondary | tumor necrosis factor-a(TNF-a) | 2-4 weeks | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Enrolling by invitation |
NCT05410795 -
Establishment and Verification of Pancreatic Volume Formula Based on Imaging
|
||
Recruiting |
NCT04195347 -
Study of CM4620 to Reduce the Severity of Pancreatitis Due to Asparaginase
|
Phase 1/Phase 2 | |
Completed |
NCT04735055 -
Artificial Intelligence Prediction for the Severity of Acute Pancreatitis
|
||
Completed |
NCT02928718 -
The Association Between Post-ERCP Acute Pancreatitis and Various Genetic Mutations
|
||
Terminated |
NCT02885441 -
Treatment of Acute Pancreatitis With Ketorolac
|
Phase 4 | |
Completed |
NCT02563080 -
Pancreatic Exocrine Insufficiency in Acute Pancreatitis
|
||
Recruiting |
NCT01626911 -
Continuous Regional Arterial Infusion of Low Molecular Weight Heparin in Patients With Severe Acute Pancreatitis
|
N/A | |
Completed |
NCT01507766 -
The Correlations Between Early Enteral Nutrition and Intra-abdominal Pressure in Severe Acute Pancreatitis
|
Phase 4 | |
Completed |
NCT04901949 -
The Course of Acute Pancreatitis in Patients With Different BMI Groups
|
||
Recruiting |
NCT04814693 -
Conventional Endoscopic Techniques Versus EndoRotor® System for Necrosectomy of Walled of Necrosis
|
N/A | |
Completed |
NCT02743364 -
Simvastatin in Reducing Pancreatitis in Patients With Recurrent, Acute or Chronic Pancreatitis
|
Phase 2 | |
Recruiting |
NCT05281458 -
Early Versus Standard Endoscopic Interventions for Peripancreatic Fluid Collections
|
N/A | |
Not yet recruiting |
NCT04990336 -
Dachaihu Decoction Compound and Rhubarb Single Medicine in the Treatment of Acute Pancreatitis
|
N/A | |
Not yet recruiting |
NCT03259880 -
Searching the Best Prognostic Factor in Out Come Evaluation in Patients With Acute Pancreatitis Admitted at Assiut University Hospitals
|
N/A | |
Completed |
NCT02543658 -
Neostigmine Treatment of Acute Pancreatitis Combined With Intra-abdominal Hypertension
|
Phase 2 | |
Recruiting |
NCT06023771 -
Invasive Intervention of Local Complications of Acute Pancreatitis
|
||
Not yet recruiting |
NCT05501314 -
Remote Home Monitoring Acute Pancreatitis
|
N/A | |
Completed |
NCT02897206 -
Imipenem Prophylaxis in Patients With Acute Pancreatitis
|
Phase 4 | |
Recruiting |
NCT03634787 -
Heat Shock Proteins: a Pathogenic Driver and Potential Therapeutic Target in Acute Pancreatitis
|
||
Active, not recruiting |
NCT04989166 -
Effect of Nano-curcumin Supplementation in Acute Pancreatitis
|
N/A |