Effects of Pectin on Flora Intestinal Colonization and Maintenance After Fecal Transplantation

NCT ID: NCT02016469

Last Updated: 2013-12-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2016-02-29

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.

Conditions

Inflammatory Bowel Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

co-transplantation of FMT and pectin

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

Group Type: EXPERIMENTAL

co-transplantation of FMT and pectin

Intervention Type: OTHER

300ml Bacterial suspension (from 60g fresh stool )for fecal microbiota transplantation the first day and 20g pectin given continuously for total five days

single fecal microbiota transplantation

300ml Bacterial suspension (from 60g fresh stool )given for the first day

Group Type: ACTIVE_COMPARATOR

single fecal microbiota transplantation

Intervention Type: OTHER

single fecal microbiota transplantation once the first day

give pectin 20g/d

pure give pectin 20g/d for five days

Group Type: ACTIVE_COMPARATOR

pure give pectin 20g/d for five days

Intervention Type: DIETARY_SUPPLEMENT

pure give pectin 20g/d for five days

Interventions

co-transplantation of FMT and pectin

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

single fecal microbiota transplantation

single fecal microbiota transplantation once the first day

Intervention Type: OTHER

pure give pectin 20g/d for five days

pure give pectin 20g/d for five days

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

for UC

1. Patients should be in the age range of 18 - 70 years;

2. Patients should have clinical, imaging, endoscopic and histological diagnosis of UC;

3. Patients should have a UCDAI score of more than 2 and less than 10 or stage at S1/S2 in Montreal Rank at enrollment;

4. Patients receiving a stable dose of concomitant medication (aminosalicylates, oral corticosteroids) for at least 4 weeks are eligible;

5. Patients are capable of providing written informed consent and obtained at the time of enrollment;

6. Patients are willing to adhere to the study visit schedule and other protocol requirements.

for CD:

1. Patients should be in the age range of 18 - 40 years;

2. Patients should have clinical, imaging, endoscopic and histological diagnosis of early CD*;

3. 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;

4. Patients receiving a stable dose of concomitant medication (aminosalicylates, oral corticosteroids) for at least 4 weeks are eligible;

5. Patients are capable of providing written informed consent and obtained at the time of enrollment;

6. Patients are willing to adhere to the study visit schedule and other protocol requirements.

Exclusion Criteria

1. Women who are pregnant or lactating at the time of enrollment, or who intend to be during the study period

2. Patients may confuse the findings or there exist any other additional risk history

3. Patients with end-stage disease or is expected likely to die during the study

4. Patients are participating in other clinical trials or participated within 3 months prior to transplantation

5. 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 -

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jinling Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

weiyao

doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of General Surgery, Jinling hosptal,Medical School of Nanjing University

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ning Li, MD

Role: CONTACT

Phone: +86-25-80863736

Email: liningrigs@vip.sina.com

Facility Contacts

Ning Li, MD

Role: primary

References

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.

Reference Type: DERIVED

PMID: 28000190 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 27809778 (View on PubMed)

Other Identifiers

IBDBP-1

Identifier Type: -

Identifier Source: org_study_id