Clinical trial NCT02016469: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Inflammatory Bowel Disease
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
First posted: 2013-12-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 -

Primary outcomes:
measure: diversity and steady state of the stool
timeFrame: 6 months
Secondary outcomes:
measure: Erythrocyte sedimentation rate
timeFrame: 6 months
measure: C-reactive protein
timeFrame: 6 months
measure: Fecal calcium protein
timeFrame: 6 months
measure: Adverse reactions after fecal microbiota transplantation and/or take pectin
timeFrame: 1 week
measure: Crohn's disease activity index
timeFrame: 6 months
measure: Ulcerative Colitis disease activity index
timeFrame: 6 months
measure: the simple endoscopic score for CD
timeFrame: 6 months
measure: Ulcerative Colitis endoscopic index of severity
timeFrame: 6 months
measure: diversity and steady state of the Intestinal mucosa
timeFrame: 6 months
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Department of General Surgery, Jinling hosptal,Medical School of Nanjing University
state: Jiangsu
Study officials:
References:
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.
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.