NCT02016469

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

December 10, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 20, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

December 20, 2013

Status Verified

December 1, 2013

Enrollment Period

2 years

First QC Date

December 10, 2013

Last Update Submit

December 15, 2013

Conditions

Inflammatory Bowel Disease

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (9)

  • Erythrocyte sedimentation rate

    6 months

  • C-reactive protein

    6 months

  • Fecal calcium protein

    6 months

  • Adverse reactions after fecal microbiota transplantation and/or take pectin

    1 week

  • Crohn's disease activity index

    6 months

  • +4 more secondary outcomes

Study Arms (3)

co-transplantation of FMT and pectin

EXPERIMENTAL

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

Other: co-transplantation of FMT and pectin

single fecal microbiota transplantation

ACTIVE COMPARATOR

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

Other: single fecal microbiota transplantation

give pectin 20g/d

ACTIVE COMPARATOR

pure give pectin 20g/d for five days

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

Interventions

co-transplantation of FMT and pectinOTHER

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

co-transplantation of FMT and pectin
single fecal microbiota transplantationOTHER

single fecal microbiota transplantation once the first day

single fecal microbiota transplantation
pure give pectin 20g/d for five daysDIETARY_SUPPLEMENT

pure give pectin 20g/d for five days

give pectin 20g/d

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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 -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Nanjing, Jiangsu, 210002, China

RECRUITING

Related Publications (2)

  • 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.

    PMID: 28000190DERIVED

  • 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.

    PMID: 27809778DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

PectinsFecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

BiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydratesPlant ExtractsPlant PreparationsBiological ProductsComplex MixturesBiological TherapyTherapeutics

Central Study Contacts

Ning Li, MD

CONTACT

+86-25-80863736liningrigs@vip.sina.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

December 10, 2013

First Posted

December 20, 2013

Study Start

December 1, 2013

Primary Completion

December 1, 2015

Study Completion

February 1, 2016

Last Updated

December 20, 2013

Record last verified: 2013-12

Locations

CN(1)