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Inflammatory Bowel Disease(IBD)IBDNCT03426683

The Effect of Intestinal Microbiota Transplantation for Inflammatory Bowel Diseases

A study testing Intestinal Microbiota Transplantation in people with Inflammatory Bowel Disease(IBD), run by Zhongshan Hospital Xiamen University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

There are many limitations in the current treatments of Inflammatory Bowel Diseases(IBD) which includes Ulcerative Colitis（UC) and Crohn's Disease(CD). Some patients have no or little reaction to the traditional drugs. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Inflammatory Bowel Disease(IBD)
What is being tested?
Intestinal Microbiota Transplantation
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteChina
Study dates
21 Nov 2017to 30 Dec 2022
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Standard or conventional medicine treatment ineffective of Inflammatory Bowel Diseases(IBD) patients
  • IBD patients with recurrent symptoms
  • IBD patients who had drug dependence or recurrence when reduced or discontinued use
  • Untreated IBD patients who voluntarily received Standardized Intestinal Microbiota Transplantation(IMT)
  • Written informed consent/assent as appropriate

Who cannot join

  • IBD patients with contraindications for gastrointestinal endoscopy
  • IBD patients with indication of surgery
  • Moderate and severe renal injuty(serum creatinine>2mg/dL or 177mmol/L), moderate and severe chronic obstructive pulmonary disease, severe hypertension, cerebrovascular accident, congestive heart failure, unstable angina pectoris
  • Other serious diseases that may interfere the recruitment or affect the survival, such as cancer or acquired immune deficiency syndrome
  • Mentally or legally disabled person
  • Preparing for pregnancy
  • Medical or social condition which in the opinion of the principal investigator would interfere with or prevent regular follow up
  • Participating in other clinical trials.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Zhongshan Hospital Affiliated to Xiamen University

    Xiamen, Fujian, 361000

Other trials in China

About this study

Official title: Efficacy, Safety and Microbiota of Intestinal Microbiota Transplantation for Inflammatory Bowel Diseases

There are many limitations in the current treatments of Inflammatory Bowel Diseases(IBD) which includes Ulcerative Colitis（UC) and Crohn's Disease(CD). Some patients have no or little reaction to the traditional drugs. Now the investigators realized that the intestinal microbiota is closely associated with the development of Inflammatory Bowel Diseases. In recent years, a retrospective study showed that the overall efficiency of intestinal microbiota transplantation for IBD was 79%, the overall remission rate was 43%, which opened a new chapter in the treatment of IBD. So the standardized intestinal microbiota transplantation is considered to be simple but effective emerging therapies for the treatment of IBD. In this project the investigators intend to carry out a single-center, randomized, single-blind clinical intervention study. The investigators plan to recruit patients with IBD in China. The patients will be randomly divided into two groups, one group will be given treatment of standardized intestinal microbiota transplantation, the other will be simply treated with traditional drugs, followed up for at least 1 year. The investigators aim to determine the efficiency, durability and safety of Intestinal Microbiota Transplantation for IBD treatment, and further to explore which major bacteria may effect in this project.

Read the detailed description

In this projects the investigators aim to re-establish a gut balance of intestinal microbiota through Standardized Intestinal Microbiota Transplantation for Ulcerative Colitis(UC) and Crohn's Disease(CD).Investigators have established a standardized isolation, store, and transport steps of fecal bacteria from donated fresh stool in the laboratory. Then the bacteria will be transplanted to mid-gut by nose-jejunum nutrition tube or capsules.Participants in this study will be assigned to receive Standardized Intestinal Microbiota Transplantation three times a week or traditional medicine and would be followed up for at least 1 year. The clinical symptoms, sign, blood tests, endoscopy and questionnaire will be used to assess the efficiency, durability and safety of Standardized Intestinal Microbiota Transplantation at the start and end of the projects. At last, investigators will use 16S-rDNA to estimate the change of intestinal microbiota.

Being tested
Intestinal Microbiota Transplantation
Keywords
Inflammatory Bowel Disease(IBD), Ulcerative colitis(UC), Crohn's disease(CD), intestinal microbiota transplantation, microbiota
Medical subject headings
Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intestinal Microbiota TransplantationOther

    the bacteria will be transplanted to mid-gut by nose-jejunum nutrition tube. Patients in this study will be assigned to receive standardized IMT three times or traditional medicine and would be followed up for at least 3 year.

Study groups in NCT03426683
Study groupRoleWhat they receive
Standardized IMTExperimentalThe patients will receive Standardized Intestinal Microbiota Transplantation(Standardized IMT). The IMT was given to mid-gut by nose-jejunum nutrition tube or capsules. It was given three times a week.
Receives: Other: Intestinal Microbiota Transplantation
traditional drugsNo interventionThe patients will receive traditional medicine treatment as usual.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The change of the modified Mayo score

    Clinical remission defined as modified Mayo score≦2. Change from baseline will be assessed at different timepoint.The endpoint of follow-up is the time of clinical recurrence.

    Measured: 1 month, 3 months, 6months, 12 months

Secondary outcomes (3)

  1. The change of CDAI

    Clinical remission defined as CDAI(Crohn's disease activity index )≦150.Change from baseline will be assessed at different timepoint. The endpoint of follow-up is the time of clinical recurrence.

    Measured: 1 month, 3 months, 6months,12 months

  2. Relief of gastrointestinal symptoms

    The onset and duration of gastrointestinal symptoms will be assessed by "Evaluation Score Table of Gastrointestinal Symptoms".Change from baseline will be assessed at different timepoint.

    Measured: 1 months, 3 months, 6 months, 12months

  3. Changes of gut microbiota

    Alpha and Beta diversity of GI microbiota by High-throughput sequencing on baseline line and1 month, 3 months, 6months ,12 months after treatment.

    Measured: 1 months, 3 months, 6 months, 12months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2018
  2. Study start21 Nov 2017
  3. Primary completion29 Oct 2021
  4. Study completion30 Dec 2022

Resources

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
Model description
an open label, parallel study
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03426683
Sponsor's protocol ID
2017004
Acronym
IBD
Status last verified
Nov 2023
First submitted
27 Oct 2017
Last updated
14 Nov 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Chen Q, Fan Y, Zhang B, Yan C, Zhang Q, Ke Y, Chen Z, Wang L, Shi H, Hu Y, Huang Q, Su J, Xie C, Zhang X, Zhou L, Ren J, Xu H. Capsulized Fecal Microbiota Transplantation Induces Remission in Patients with Ulcerative Colitis by Gut Microbial Colonization and Metabolite Regulation. Microbiol Spectr. 2023 Jun 15;11(3):e0415222. doi: 10.1128/spectrum.04152-22. Epub 2023 Apr 24.

    PubMed 37093057

  • Chen Q, Fan Y, Zhang B, Yan C, Chen Z, Wang L, Hu Y, Huang Q, Su J, Ren J, Xu H. Specific fungi associated with response to capsulized fecal microbiota transplantation in patients with active ulcerative colitis. Front Cell Infect Microbiol. 2023 Jan 5;12:1086885. doi: 10.3389/fcimb.2022.1086885. eCollection 2022.

    PubMed 36683707

Questions about this trial

What is this clinical trial studying?

A study testing Intestinal Microbiota Transplantation in people with Inflammatory Bowel Disease(IBD), run by Zhongshan Hospital Xiamen University 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 5 inclusion and 8 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: finished, as of the sponsor's last update on 14 Nov 2023. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The change of the modified Mayo score (time frame: 1 month, 3 months, 6months, 12 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 NCT03426683, 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 14 Nov 2023.

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