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

Not Applicable

• Conditions: Crohn's Diseases
• Interventions: Procedure: WMT; Dietary Supplement: EEN

• Registration Number: NCT02897661
• Lead Sponsor: The Second Hospital of Nanjing Medical University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-08-14
• Study First Submitted QC: 2016-09-07
• Study First Posted: 2016-09-13
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-22
• Last Update Posted: 2020-07-23
• Primary Completion: 2020-08
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early WMT and EEN	EEN	WMT (day1), EEN (day1-15)
Late WMT and EEN	EEN	WMT (day8), EEN (day1-15)
Early WMT and EEN	WMT	WMT (day1), EEN (day1-15)
Late WMT and EEN	WMT	WMT (day8), EEN (day1-15)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
rate of clinical remission	day 15	HBI score ≤ 4

Trial Locations

Locations (1)

Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China