Acute PancreatitisPhase 1/2NCT03015467
Fecal Microbiota Transplantation (FMT) for Severe Acute Pancreatitis(SAP)
A Phase 1/2 study testing Fecal Microbiota Transplantation and normal saline in people with Acute Pancreatitis and Intestinal Bacteria Flora Disturbance, run by First Affiliated Hospital of Chengdu Medical College at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Pancreatitis, Intestinal Bacteria Flora Disturbance, Intestinal Dysfunction
- What is being tested?
- Fecal Microbiota Transplantation and normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Dec 2016to Mar 2020
- Phase
- Phase 1/2
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
- No chronic diseases of the digestive system ;
- No chronic diseases of the urinary system;
- No chronic metabolic disease;
- No chronic disease of immune system
- No chronic disease of mental disease
- no acute intestinal disease; taking antibiotics anti-inflammatory drugs and history of probiotics for one month;
- No use of addictive drugs and immune inhibitors
Who cannot join
- not to match the standard of AP
- with chronic diseases of the digestive system;
- with chronic diseases of the urinary system;
- with chronic metabolic disease;
- with chronic disease of immune system
- with chronic disease of mental disease
Show all 9Show fewer
- with acute intestinal disease; taking antibiotics anti-inflammatory drugs and history of probiotics for one month;pregnancy and lactation women
- with use of addictive drugs and immune inhibitors
- exceed the age limits
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
IEC of Chengdu Medical College
Chendu, 610500
Xiao-an Li, post doctor, +8613680868858, zqzy1983@163.com
About this study
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.
Read the detailed description
Patients with acute pancreatitis will be assessed depending on APACHE II and CT score and all of them also will be separated into two parts depending on acceptation or refusal of FMT. Blood specimens from patients will be collected to analysis inflammatory factors，and fecal microbiota samples will be detection.
- Conditions
- Acute Pancreatitis, Intestinal Bacteria Flora Disturbance, Intestinal Dysfunction, Fecal Microbiota Transplantation
- Being tested
- Fecal Microbiota Transplantation, normal saline
- Keywords
- acute pancreatitis, intestinal mucosal barrier, Fecal Microbiota Transplantation
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Microbiota TransplantationOther
Also called Fecal Microbiota Transplantation (FMT)
Fecal Microbiota Transplantation and the traditional treatments for Acute Pancreatitis with gut mucosal barrier dysfunction and unbalance of gut microflora in part 1
normal salineOther
Also called normal saline (NS)
normal saline and the traditional treatments for Acute Pancreatitis with gut mucosal barrier dysfunction and unbalance of gut microflora in part 2
| Study group | Role | What they receive |
|---|---|---|
| treatment for part 1 | Active comparator | Fecal Microbiota Transplantation (FMT) and traditional treatments according to associated guidelines will be used in patients with severe acute pancreatitis(SAP) in part 1. Receives: Other: Fecal Microbiota Transplantation |
| Placebo for part 2 | Placebo comparator | The traditional treatments and normal saline (NS) according to associated guidelines will be used in patients with severe acute pancreatitis(SAP) in part 2. Receives: Other: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: 3 months
Secondary outcomes (4)
C-reactive protein（CRP）
Measured: 2-4 weeks
Diamine oxidase（DAO）
Measured: 2-4 weeks
Interleukin
Measured: 2-4 weeks
tumor necrosis factor-a(TNF-a)
Measured: 2-4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2017 (estimated)
- Study startDec 2016
- Primary completionDec 2019 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Acute 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Chengdu Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Li Fang, Ph.D, Study chair, First Affiliated Hospital of Chengdu Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03015467
- Sponsor's protocol ID
- AM-FMT-SAP
- Status last verified
- Jan 2017
- First submitted
- 3 Jan 2017
- Last updated
- 11 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 21206096Murphy 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. Epub 2014 Sep 18.
PubMed 25234043Wu 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. Epub 2014 Oct 21.
PubMed 25334028Fishman 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.
PubMed 24978882Schwender 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.
PubMed 25872170Hall 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.
PubMed 25003605Senocak R, Yigit T, Kilbas Z, Coskun AK, Harlak A, Mentes MO, Kilic A, Gunal 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. Epub 2013 Jan 31.
PubMed 26730036Bongaerts 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.
PubMed 26744983Hansson 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. doi: 10.4161/gmic.1.1.10470.
PubMed 21327117Zhang 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.
PubMed 18257123
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alteration of Intestinal Microflora and Efficacy and Safety of Fecal Microbiota Transplantation for Severe Acute Pancreatitis
- ClinicalTrials.gov ID
- NCT03015467
- Acronym / sponsor ID
- AM-FMT-SAP
- Conditions
- Acute Pancreatitis, Intestinal Bacteria Flora Disturbance, Intestinal Dysfunction, Fecal Microbiota Transplantation
- Keywords
- acute pancreatitis, intestinal mucosal barrier, Fecal Microbiota Transplantation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Chengdu Medical CollegeUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 10 Jan 2017 (estimated)
- 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.
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.
Detailed description
Patients with acute pancreatitis will be assessed depending on APACHE II and CT score and all of them also will be separated into two parts depending on acceptation or refusal of FMT. Blood specimens from patients will be collected to analysis inflammatory factors，and fecal microbiota samples will be detection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment for part 1 | Active comparator | Other: Fecal Microbiota TransplantationFecal Microbiota Transplantation (FMT) and traditional treatments according to associated guidelines will be used in patients with severe acute pancreatitis(SAP) in part 1. |
| Placebo for part 2 | Placebo comparator | Other: normal salineThe traditional treatments and normal saline (NS) according to associated guidelines will be used in patients with severe acute pancreatitis(SAP) in part 2. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
- No chronic diseases of the digestive system ;
- No chronic diseases of the urinary system;
- No chronic metabolic disease;
- No chronic disease of immune system
Key exclusion criteria (9 listed)
- not to match the standard of AP
- with chronic diseases of the digestive system;
- with chronic diseases of the urinary system;
- with chronic metabolic disease;
- with chronic disease of immune system
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 |
|---|---|---|
| Fecal Microbiota TransplantationAlso: Fecal Microbiota Transplantation (FMT)Fecal Microbiota Transplantation and the traditional treatments for Acute Pancreatitis with gut mucosal barrier dysfunction and unbalance of gut microflora in part 1 | Other | treatment for part 1 |
| normal salineAlso: normal saline (NS)normal saline and the traditional treatments for Acute Pancreatitis with gut mucosal barrier dysfunction and unbalance of gut microflora in part 2 | Other | Placebo for part 2 |
Primary outcome
Mortality
Time frame: 3 months
4 secondary outcomes
C-reactive protein（CRP）
Time frame: 2-4 weeks
Diamine oxidase（DAO）
Time frame: 2-4 weeks
Interleukin
Time frame: 2-4 weeks
tumor necrosis factor-a(TNF-a)
Time frame: 2-4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2017.
- Background: PubMed 21206096Noor 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.
- Background: PubMed 25234043Murphy 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. Epub 2014 Sep 18.
- Background: PubMed 25334028Wu 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. Epub 2014 Oct 21.
- Background: PubMed 24978882Fishman 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.
- Background: PubMed 25872170Schwender 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.
- Background: PubMed 25003605Hall 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.
- Background: PubMed 26730036Senocak R, Yigit T, Kilbas Z, Coskun AK, Harlak A, Mentes MO, Kilic A, Gunal 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. Epub 2013 Jan 31.
- Background: PubMed 26744983Bongaerts 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.
- Background: PubMed 21327117Hansson 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. doi: 10.4161/gmic.1.1.10470.
- Background: PubMed 18257123Zhang 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.
- Individual participant dataSharing planned: No
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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.
Li Fang, Ph.D study chair
First Affiliated Hospital of Chengdu Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Fecal Microbiota Transplantation and normal saline in people with Acute Pancreatitis and Intestinal Bacteria Flora Disturbance, run by First Affiliated Hospital of Chengdu Medical College at 1 site in China.
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 8 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 11 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li Fang, Ph.D (+8613458555780, fangzjt@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03015467, which also lists 10 linked publications.
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 11 Jan 2017.