Effects of Pectin on Flora Intestinal Colonization and Maintenance After Fecal Transplantation
Primary Purpose
Inflammatory Bowel Disease
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
co-transplantation of FMT and pectin
single fecal microbiota transplantation
pure give pectin 20g/d for five days
Sponsored by
About this trial
This is an interventional treatment trial for Inflammatory Bowel Disease
Eligibility Criteria
Inclusion Criteria:
for UC
- Patients should be in the age range of 18 - 70 years;
- Patients should have clinical, imaging, endoscopic and histological diagnosis of UC;
- Patients should have a UCDAI score of more than 2 and less than 10 or stage at S1/S2 in Montreal Rank at enrollment;
- Patients receiving a stable dose of concomitant medication (aminosalicylates, oral corticosteroids) for at least 4 weeks are eligible;
- Patients are capable of providing written informed consent and obtained at the time of enrollment;
- Patients are willing to adhere to the study visit schedule and other protocol requirements.
for CD:
- Patients should be in the age range of 18 - 40 years;
- Patients should have clinical, imaging, endoscopic and histological diagnosis of early CD*;
- Patients should have a CDAI score of more than 150 and less than 400and have a C-reactive protein (CRP) level of more than10mg/L at enrollment;
- Patients receiving a stable dose of concomitant medication (aminosalicylates, oral corticosteroids) for at least 4 weeks are eligible;
- Patients are capable of providing written informed consent and obtained at the time of enrollment;
- Patients are willing to adhere to the study visit schedule and other protocol requirements.
Exclusion Criteria:
- Women who are pregnant or lactating at the time of enrollment, or who intend to be during the study period
- Patients may confuse the findings or there exist any other additional risk history
- Patients with end-stage disease or is expected likely to die during the study
- Patients are participating in other clinical trials or participated within 3 months prior to transplantation
- Outbreaks, infectious (viruses, bacteria, parasites, or other microorganisms) colitis, scheduled for abdominal surgery,take probiotics / prebiotics / synbiotics / antibiotic / PPI (past 1 month) orally, severe anemia (Hbg <6g/dl), heart cerebrovascular accident, bypass, stent implantation surgery in the last 6 months, coagulation disorders, immune suppression status (defined as: immunosuppressive drugs, a history of opportunistic infections within one year recurrent ,oral ulcers, multiple lymphadenopathy, neutropenia, etc.), major abdominal transplant surgery in the last 3 months, have took TNF-α monoclonal antibody 2 month before transplantation or planned to take within one month after transplantation, a history of megacolon -
Sites / Locations
- Department of General Surgery, Jinling hosptal,Medical School of Nanjing UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
co-transplantation of FMT and pectin
single fecal microbiota transplantation
give pectin 20g/d
Arm Description
300ml Bacterial suspension (from 60g fresh stool )given for the first day and 20g pectin given from the second to the sixth day for total five days
300ml Bacterial suspension (from 60g fresh stool )given for the first day
pure give pectin 20g/d for five days
Outcomes
Primary Outcome Measures
diversity and steady state of the stool
Change from Baseline in diversity and steady state of the stool every week within one month after the intervention and three and six months after intervention
Secondary Outcome Measures
Erythrocyte sedimentation rate
Change from Baseline in ESR 1st,3st,6st month after intervention
C-reactive protein
Change from Baseline in CRP 1st,3st,6st month after intervention
Fecal calcium protein
Change from Baseline in Fecal calcium protein 1st,3st,6st month after intervention
Adverse reactions after fecal microbiota transplantation and/or take pectin
every day within one week after the intervention
Crohn's disease activity index
Change from Baseline in CDAI two weeks,one,three and six months after intervention
Ulcerative Colitis disease activity index
Change from Baseline in UCDAItwo weeks,one,three and six months after intervention
the simple endoscopic score for CD
Change from Baseline in SEC-CD 3st,6st months after intervention
Ulcerative Colitis endoscopic index of severity
Change from Baseline in UCDEIS 3st and 6st month after intervention
diversity and steady state of the Intestinal mucosa
Change from Baseline in diversity and steady state of the intestinal mucosa three and six months after intervention
Full Information
NCT ID
NCT02016469
First Posted
December 10, 2013
Last Updated
December 15, 2013
Sponsor
Jinling Hospital, China
1. Study Identification
Unique Protocol Identification Number
NCT02016469
Brief Title
Effects of Pectin on Flora Intestinal Colonization and Maintenance After Fecal Transplantation
Official Title
A Randomized, Controlled, Single-blind Study of Effects of Pectin on Flora Intestinal Colonization and Maintenance After Fecal Transplantation to Patients With Inflammatory Bowel Disease
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Unknown status
Study Start Date
December 2013 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
February 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jinling Hospital, China
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the effect and safety of pectin and fecal microbiota transplantation on patients with inflammatory bowel disease. The investigators hypothesize that patients who take pectin can promote the migration of probiotics in intestine engraftment, reduce pathogenic agents'adhesion to intestinal mucosa, cut down the inflammation, and to maintain intestinal flora diversity and steady state in a long time.
Detailed Description
Inflammatory bowel disease (IBD) is a chronic relapsing disease, including ulcerative colitis (UC) and Crohn's disease (CD). Although the etiology of IBD is unknown, but more and more evidence show that the inappropriate immune response to intestinal commensal bacteria leading to dysbiosis, and pathogens further act to the mucosal lymphoid tissue, causing IBD. Has yet not to determine the specific one or more pathogens as the cause of IBD,but literatures confirm the changes of diversity of the intestine flora.Based on the current awareness of changes in the intestinal flora in IBD, fecal microbiota transplantation (FMT) proposed in recent years to rebuild the intestine flora balance to achieve therapeutic purposes. But fecal bacteria of patients can not consistent with donor's for a long term after transplantation and therefore it is not an ideal way for disease control. Maintaining the diversity of flora in a long time so that well controlled the disease become the breakthrough of fecal microbiota transplantation in the treatment of inflammatory bowel disease.
Pectin is a soluble dietary fiber (DF), produced by the gut flora after a series of fermentation with many metabolites such as short chain fatty acids (SCFA) which supply the energy for epithelial cells, regulate intestinal PH and intestinal motility and join effort in immune regulation with intestinal lymphoid tissue. Previous studies showed that: water-soluble dietary fiber with the action of intestinal flora can cut the inflammatory cytokines, prevent inflammation and induce regulatory T cells, but the type and dose of dietary fiber used were different in different studies, and no studies have confirmed whether dietary fiber could adjusted the flora colonization ability in patients with IBD. We conceive that pectin by some mechanism to promote the migration of probiotics in intestine engraftment, reduce pathogenic agents' adhesion of intestinal mucosa, cut inflammation, and to maintain intestinal flora diversity and steady state in a long time, and than achieve the goal of continue to ease IBD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
co-transplantation of FMT and pectin
Arm Type
Experimental
Arm Description
300ml Bacterial suspension (from 60g fresh stool )given for the first day and 20g pectin given from the second to the sixth day for total five days
Arm Title
single fecal microbiota transplantation
Arm Type
Active Comparator
Arm Description
300ml Bacterial suspension (from 60g fresh stool )given for the first day
Arm Title
give pectin 20g/d
Arm Type
Active Comparator
Arm Description
pure give pectin 20g/d for five days
Intervention Type
Other
Intervention Name(s)
co-transplantation of FMT and pectin
Intervention Description
300ml Bacterial suspension (from 60g fresh stool )for fecal microbiota transplantation the first day and 20g pectin given continuously for total five days
Intervention Type
Other
Intervention Name(s)
single fecal microbiota transplantation
Intervention Description
single fecal microbiota transplantation once the first day
Intervention Type
Dietary Supplement
Intervention Name(s)
pure give pectin 20g/d for five days
Intervention Description
pure give pectin 20g/d for five days
Primary Outcome Measure Information:
Title
diversity and steady state of the stool
Description
Change from Baseline in diversity and steady state of the stool every week within one month after the intervention and three and six months after intervention
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Erythrocyte sedimentation rate
Description
Change from Baseline in ESR 1st,3st,6st month after intervention
Time Frame
6 months
Title
C-reactive protein
Description
Change from Baseline in CRP 1st,3st,6st month after intervention
Time Frame
6 months
Title
Fecal calcium protein
Description
Change from Baseline in Fecal calcium protein 1st,3st,6st month after intervention
Time Frame
6 months
Title
Adverse reactions after fecal microbiota transplantation and/or take pectin
Description
every day within one week after the intervention
Time Frame
1 week
Title
Crohn's disease activity index
Description
Change from Baseline in CDAI two weeks,one,three and six months after intervention
Time Frame
6 months
Title
Ulcerative Colitis disease activity index
Description
Change from Baseline in UCDAItwo weeks,one,three and six months after intervention
Time Frame
6 months
Title
the simple endoscopic score for CD
Description
Change from Baseline in SEC-CD 3st,6st months after intervention
Time Frame
6 months
Title
Ulcerative Colitis endoscopic index of severity
Description
Change from Baseline in UCDEIS 3st and 6st month after intervention
Time Frame
6 months
Title
diversity and steady state of the Intestinal mucosa
Description
Change from Baseline in diversity and steady state of the intestinal mucosa three and six months after intervention
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
for UC
Patients should be in the age range of 18 - 70 years;
Patients should have clinical, imaging, endoscopic and histological diagnosis of UC;
Patients should have a UCDAI score of more than 2 and less than 10 or stage at S1/S2 in Montreal Rank at enrollment;
Patients receiving a stable dose of concomitant medication (aminosalicylates, oral corticosteroids) for at least 4 weeks are eligible;
Patients are capable of providing written informed consent and obtained at the time of enrollment;
Patients are willing to adhere to the study visit schedule and other protocol requirements.
for CD:
Patients should be in the age range of 18 - 40 years;
Patients should have clinical, imaging, endoscopic and histological diagnosis of early CD*;
Patients should have a CDAI score of more than 150 and less than 400and have a C-reactive protein (CRP) level of more than10mg/L at enrollment;
Patients receiving a stable dose of concomitant medication (aminosalicylates, oral corticosteroids) for at least 4 weeks are eligible;
Patients are capable of providing written informed consent and obtained at the time of enrollment;
Patients are willing to adhere to the study visit schedule and other protocol requirements.
Exclusion Criteria:
Women who are pregnant or lactating at the time of enrollment, or who intend to be during the study period
Patients may confuse the findings or there exist any other additional risk history
Patients with end-stage disease or is expected likely to die during the study
Patients are participating in other clinical trials or participated within 3 months prior to transplantation
Outbreaks, infectious (viruses, bacteria, parasites, or other microorganisms) colitis, scheduled for abdominal surgery,take probiotics / prebiotics / synbiotics / antibiotic / PPI (past 1 month) orally, severe anemia (Hbg <6g/dl), heart cerebrovascular accident, bypass, stent implantation surgery in the last 6 months, coagulation disorders, immune suppression status (defined as: immunosuppressive drugs, a history of opportunistic infections within one year recurrent ,oral ulcers, multiple lymphadenopathy, neutropenia, etc.), major abdominal transplant surgery in the last 3 months, have took TNF-α monoclonal antibody 2 month before transplantation or planned to take within one month after transplantation, a history of megacolon -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ning Li, MD
Phone
+86-25-80863736
Email
liningrigs@vip.sina.com
Facility Information:
Facility Name
Department of General Surgery, Jinling hosptal,Medical School of Nanjing University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ning Li, MD
Phone
+86-25-80863736
Email
liningrigs@vip.sina.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
28000190
Citation
Ge X, Ding C, Gong J, Tian H, Wei Y, Chen Q, Gu L, Li N. [Short-term efficacy on fecal microbiota transplantation combined with soluble dietary fiber and probiotics in the treatment of slow transit constipation]. Zhonghua Wei Chang Wai Ke Za Zhi. 2016 Dec 25;19(12):1355-1359. Chinese.
Results Reference
derived
PubMed Identifier
27809778
Citation
Wei Y, Gong J, Zhu W, Tian H, Ding C, Gu L, Li N, Li J. Pectin enhances the effect of fecal microbiota transplantation in ulcerative colitis by delaying the loss of diversity of gut flora. BMC Microbiol. 2016 Nov 3;16(1):255. doi: 10.1186/s12866-016-0869-2.
Results Reference
derived
Learn more about this trial
Effects of Pectin on Flora Intestinal Colonization and Maintenance After Fecal Transplantation
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