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

Study Overview
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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.

Official Title
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Washed Microbiota Transplantation Combining Exclusive Enteral Nutrition Contribute to Nutritional Improvement of Patients With Crohns' Disease

Conditions
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Crohn's Diseases

Intervention / Treatment
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* Procedure: WMT
* Dietary Supplement: EEN


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients aged 18 to 65 years with active CD, as defined by Harvey-Bradshaw Index (HBI) score >4; patients accompanied with malnutrition as assessed by Nutritional Risk Screening 2002 (NRS2002) score ≥ 3 or Patient-Generated Subjective Global Assessment (PG-SGA) score ≥ 4; patients with high compliance. Exclusion Criteria: accompanying with contraindications of enteral nutrition (EN) such as ileus, active gastrointestinal bleeding and shock; severe comorbidities (e.g., Clostridium difficile infection, diabetes, cancer, cardiopulmonary failure and severe liver and kidney diseases; parenteral infection such as urinary infection, pneumonia, etc; steroids or biologicals use within 6 week; intestinal fibrotic stenosis; patients who are pregnant or going to be pregnant; patients with mental disorders.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early WMT and EEN<br>WMT (day1), EEN (day1-15) | Procedure: WMT<br>* Washed microbiota transplantation (WMT) through mid-gut<br>Dietary Supplement: EEN<br>* Exclusive enteral nutrition (EEN) through feeding tube<br>|
| Experimental: Late WMT and EEN<br>WMT (day8), EEN (day1-15) | Procedure: WMT<br>* Washed microbiota transplantation (WMT) through mid-gut<br>Dietary Supplement: EEN<br>* Exclusive enteral nutrition (EEN) through feeding tube<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in hemoglobin |  | Day 8 and day 15 | 
| changes in albumin and prealbumin in g/L |  | Day 8 and day 15 | 
| changes in lymphocyte count in 10^9/L |  | Day 8 and day 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of clinical remission | HBI score ≤ 4 | day 15 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fecal microbiota transplantation, exclusive enteral nutrition, washed microbiota transplantation, malnutrition