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

Inflammatory Bowel Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02016469
• Other study ID #: IBDBP-1
• Status: Recruiting
• Phase: N/A
• First received: December 10, 2013
• Last updated: December 15, 2013
• Start date: December 2013
• Est. completion date: February 2016

Study information

• Verified date: December 2013
• Source: Jinling Hospital, China
• Contact: Ning Li, MD
• Phone: +86-25-80863736
• Email: liningrigs[@]vip.sina.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: February 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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-a monoclonal antibody 2 month before transplantation or planned to take within one month after transplantation, a history of megacolon -

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Other:
• 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
• single fecal microbiota transplantation
single fecal microbiota transplantation once the first day

Dietary Supplement:
• pure give pectin 20g/d for five days
pure give pectin 20g/d for five days

Locations

Country	Name	City	State
China	Department of General Surgery, Jinling hosptal,Medical School of Nanjing University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Jinling Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 months	No
Secondary	Erythrocyte sedimentation rate	Change from Baseline in ESR 1st,3st,6st month after intervention	6 months	No
Secondary	C-reactive protein	Change from Baseline in CRP 1st,3st,6st month after intervention	6 months	No
Secondary	Fecal calcium protein	Change from Baseline in Fecal calcium protein 1st,3st,6st month after intervention	6 months	No
Secondary	Adverse reactions after fecal microbiota transplantation and/or take pectin	every day within one week after the intervention	1 week	Yes
Secondary	Crohn's disease activity index	Change from Baseline in CDAI two weeks,one,three and six months after intervention	6 months	No
Secondary	Ulcerative Colitis disease activity index	Change from Baseline in UCDAItwo weeks,one,three and six months after intervention	6 months	No
Secondary	the simple endoscopic score for CD	Change from Baseline in SEC-CD 3st,6st months after intervention	6 months	No
Secondary	Ulcerative Colitis endoscopic index of severity	Change from Baseline in UCDEIS 3st and 6st month after intervention	6 months	No
Secondary	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	6 months	No