Washed Microbiota Transplantation Improves Nutritional Status of Patients With Crohn's Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2020-12-31

Brief Summary

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Patients with Crohns' disease (CD) are always complicated with malnutrition. Exclusive enteral nutrition (EEN) is an effective treatment to improve nutritional status and induce remission in patients with CD however a reduction in microbiota diversity was the most frequently reported effect of EEN. There was a raised critical question that whether EEN combining microbiota transplantation can bring much more benefits to those CD patients with malnutrition.

Fecal microbiota transplantation (FMT) is an effective way of remodeling microbiota. The improved methodology of FMT in our group since 2014 was different from the traditional manual FMT and was recently coined as washed microbiota transplantation (WMT), which is dependent on the automatic facilities and washing process in a laboratory room with biosafety level 3.

Importantly, the worse nutritional status might decrease the efficacy of FMT. Therefore, there was a raised critical question that when is the proper time to combine WMT for those CD patients requiring EEN. This trial aimed to explore the timing of WMT in CD patients with malnutrition and assess the efficacy and safety of the strategy using WMT combined with EEN in CD patients.

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Detailed Description

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Conditions

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Crohn's Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Early WMT and EEN

WMT (day1), EEN (day1-15)

Group Type EXPERIMENTAL

WMT

Intervention Type PROCEDURE

Washed microbiota transplantation (WMT) through mid-gut

EEN

Intervention Type DIETARY_SUPPLEMENT

Exclusive enteral nutrition (EEN) through feeding tube

Late WMT and EEN

WMT (day8), EEN (day1-15)

Group Type EXPERIMENTAL

WMT

Intervention Type PROCEDURE

Washed microbiota transplantation (WMT) through mid-gut

EEN

Intervention Type DIETARY_SUPPLEMENT

Exclusive enteral nutrition (EEN) through feeding tube

Interventions

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WMT

Washed microbiota transplantation (WMT) through mid-gut

Intervention Type PROCEDURE

EEN

Exclusive enteral nutrition (EEN) through feeding tube

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

1. patients aged 18 to 65 years with active CD, as defined by Harvey-Bradshaw Index (HBI) score \>4;
2. patients accompanied with malnutrition as assessed by Nutritional Risk Screening 2002 (NRS2002) score ≥ 3 or Patient-Generated Subjective Global Assessment (PG-SGA) score ≥ 4;
3. patients with high compliance.

Exclusion Criteria

1. accompanying with contraindications of enteral nutrition (EN) such as ileus, active gastrointestinal bleeding and shock;
2. severe comorbidities (e.g., Clostridium difficile infection, diabetes, cancer, cardiopulmonary failure and severe liver and kidney diseases;
3. parenteral infection such as urinary infection, pneumonia, etc;
4. steroids or biologicals use within 6 week;
5. intestinal fibrotic stenosis;
6. patients who are pregnant or going to be pregnant;
7. patients with mental disorders.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No