Inflammatory Bowel DiseaseNCT02016469
Effects of Pectin on Flora Intestinal Colonization and Maintenance After Fecal Transplantation
A study testing co-transplantation of FMT and pectin, single fecal microbiota transplantation and pure give pectin 20g/d for five days in people with Inflammatory Bowel Disease, run by Jinling Hospital, China at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Inflammatory Bowel Disease
- What is being tested?
- co-transplantation of FMT and pectin, single fecal microbiota transplantation and pure give pectin 20g/d for five days
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Dec 2013to Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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 -
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of General Surgery, Jinling hosptal,Medical School of Nanjing University
Nanjing, Jiangsu, 210002
Ning Li, MD, +86-25-80863736, liningrigs@vip.sina.com
About this study
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
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.
Read the 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
- Being tested
- co-transplantation of FMT and pectin, single fecal microbiota transplantation, pure give pectin 20g/d for five days
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
single fecal microbiota transplantationOther
single fecal microbiota transplantation once the first day
pure give pectin 20g/d for five daysDietary supplement
pure give pectin 20g/d for five days
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: single fecal microbiota transplantation |
| give pectin 20g/d | Active comparator | pure give pectin 20g/d for five days Receives: Dietary Supplement: pure give pectin 20g/d for five days |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (9)
Erythrocyte sedimentation rate
Change from Baseline in ESR 1st,3st,6st month after intervention
Measured: 6 months
C-reactive protein
Change from Baseline in CRP 1st,3st,6st month after intervention
Measured: 6 months
Fecal calcium protein
Change from Baseline in Fecal calcium protein 1st,3st,6st month after intervention
Measured: 6 months
Adverse reactions after fecal microbiota transplantation and/or take pectin
every day within one week after the intervention
Measured: 1 week
Crohn's disease activity index
Change from Baseline in CDAI two weeks,one,three and six months after intervention
Measured: 6 months
Ulcerative Colitis disease activity index
Change from Baseline in UCDAItwo weeks,one,three and six months after intervention
Measured: 6 months
the simple endoscopic score for CD
Change from Baseline in SEC-CD 3st,6st months after intervention
Measured: 6 months
Ulcerative Colitis endoscopic index of severity
Change from Baseline in UCDEIS 3st and 6st month after intervention
Measured: 6 months
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionDec 2015 (estimated)
- Study completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinling Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, weiyao, Jinling Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02016469
- Sponsor's protocol ID
- IBDBP-1
- Status last verified
- Dec 2013
- First submitted
- 10 Dec 2013
- Last updated
- 20 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 28000190Wei 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.
PubMed 27809778
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02016469
- Acronym / sponsor ID
- IBDBP-1
- Conditions
- Inflammatory Bowel Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Jinling Hospital, ChinaUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 20 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| co-transplantation of FMT and pectin | Experimental | Other: co-transplantation of FMT and pectin300ml 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 |
| single fecal microbiota transplantation | Active comparator | Other: single fecal microbiota transplantation300ml Bacterial suspension (from 60g fresh stool )given for the first day |
| give pectin 20g/d | Active comparator | Dietary Supplement: pure give pectin 20g/d for five dayspure give pectin 20g/d for five days |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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;
Key exclusion criteria (5 listed)
- 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 -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| co-transplantation of FMT and pectin300ml Bacterial suspension (from 60g fresh stool )for fecal microbiota transplantation the first day and 20g pectin given continuously for total five days | Other | co-transplantation of FMT and pectin |
| single fecal microbiota transplantationsingle fecal microbiota transplantation once the first day | Other | single fecal microbiota transplantation |
| pure give pectin 20g/d for five dayspure give pectin 20g/d for five days | Dietary supplement | give pectin 20g/d |
Primary outcome
diversity and steady state of the stool
Time frame: 6 months
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
9 secondary outcomes
Erythrocyte sedimentation rate
Time frame: 6 months
C-reactive protein
Time frame: 6 months
Fecal calcium protein
Time frame: 6 months
Adverse reactions after fecal microbiota transplantation and/or take pectin
Time frame: 1 week
Crohn's disease activity index
Time frame: 6 months
Ulcerative Colitis disease activity index
Time frame: 6 months
the simple endoscopic score for CD
Time frame: 6 months
Ulcerative Colitis endoscopic index of severity
Time frame: 6 months
diversity and steady state of the Intestinal mucosa
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2013.
- Derived from this study: PubMed 28000190Ge 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.
- Derived from this study: PubMed 27809778Wei 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing co-transplantation of FMT and pectin, single fecal microbiota transplantation and pure give pectin 20g/d for five days in people with Inflammatory Bowel Disease, run by Jinling Hospital, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ning Li, MD (+86-25-80863736, liningrigs@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diversity and steady state of the stool (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02016469, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2013.