Regulation of Vitamin D Metabolism by Washed Microbiota Transplantation in Patients With IBD

October 30, 2021 updated by: The Second Hospital of Nanjing Medical University

Regulation of Vitamin D Metabolism by Washed Microbiota Transplantation in Patients With Inflammatory Bowel Disease

WMT could effectively induce clinical response and maintain remission in patients with Inflammatory bowel disease (IBD). VD maintains gut microbiota and gut microbiota alter intestinal vitamin D metabolism (VDM),The aim of this study was to evaluate the effect of WMT on VD metabolism by measuring the level of serum 25(OH)D in IBD patients before and after treatment

Study Overview

Status

Recruiting

Conditions

Detailed Description

Inflammatory bowel disease (IBD) is a chronic, relapsing disorder that is represented by Crohn's disease (CD) and Ulcerative colitis (UC), the pathogenesis of IBD is not completely understood, but it is now acknowledged that it is related to intestinal microbiota. The gut microbiota is a central regulator of host metabolism, More and more evidences show that the gut microbiota plays an important physiological role in the pathogenesis of a variety of human metabolic, immune and neurological diseases, including IBD. Fecal microbiota transplantation (FMT) transplants the gut microbiota of healthy donors into the patients' intestines, This is an effective strategy to restore the intestinal microbiota and it is also a hot research topic in recent years. Our previous studies and other studies have proved that FMT could effectively induce clinical response and maintain remission in patients with IBD. Washed microbiota transplantation (WMT) is a fecal bacteria transplantation based on Intelligent fecal bacteria separation system and strict quality control of washing process, It is a new stage of FMT development, our group have proved that WMT is safer, more precise and more quality-controllable than the crude FMT by manual.

Vitamin D(VD) has been shown to have multifaced effects on the skeletal environment,immune system and infection. A number of diseases, including tumors, Type I diabetes, IBD and autoimmune diseases are associated with VD deficiency, VD could have an important role in the prevention and possible treatment of these conditions. Several studies have shown that intestinal microbiota is closely related to VD，VD maintains gut microbiota and gut microbiota alter intestinal vitamin D metabolism (VDM). A clinical trial shows that probiotics supplementation can change the level of 25 hydroxyvitaminD(25(OH)D). Serum 25(OH)D correlates with overall storage of VD, which is the preferred clinical measure to assess VD sufficiency. The aim of this study was to evaluate the effect of WMT on VD metabolism by measuring the level of serum 25(OH)D in IBD patients before and after treatment

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Recruiting
        • The Secon affiliated hospital of Nanjing Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

all patients with UC or CD were recruited from the Second Affiliated Hospital of Nanjing Medical University between March 2016 and June 2021

Description

Inclusion Criteria:

  • IBD patients aged 16-65years

Exclusion Criteria:

  • previous history of partial small bowel resection;
  • Abnormal thyroid and parathyroid function;
  • Complicated with complicated intestinal fistula and severe infection and treated with antibiotics
  • Women during pregnancy, lactation and oral contraceptives.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
CD patients treated with WMT
the gastrointestinal experts decided the treatment plan according to the patient's condition and the patient's wishes, these CD patients treated with WMT
CD patients treated without WMT
the gastrointestinal experts decided the treatment plan according to the patient's condition and the patient's wishes, these CD patients treated without WMT
UC patients treated with WMT
the gastrointestinal experts decided the treatment plan according to the patient's condition and the patient's wishes, these UC patients treated with WMT
UC patients treated without WMT
the gastrointestinal experts decided the treatment plan according to the patient's condition and the patient's wishes, these UC patients treated without WMT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of vitamin D levels in IBD patients after FMT treatment
Time Frame: 3 months
After WMT treatment, the level of vitamin d in IBD patients increased
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Second Hospital of Nanjing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Anticipated)

December 30, 2021

Study Completion (Anticipated)

December 30, 2021

Study Registration Dates

First Submitted

July 22, 2021

First Submitted That Met QC Criteria

August 3, 2021

First Posted (Actual)

August 4, 2021

Study Record Updates

Last Update Posted (Actual)

November 8, 2021

Last Update Submitted That Met QC Criteria

October 30, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • WMT-CN-160301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on IBD

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Indonesia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe