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

Primary Purpose

Crohn's Diseases

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
WMT
EEN
Sponsored by
The Second Hospital of Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Diseases focused on measuring fecal microbiota transplantation, exclusive enteral nutrition, washed microbiota transplantation, malnutrition

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Early WMT and EEN

Late WMT and EEN

Arm Description

WMT (day1), EEN (day1-15)

WMT (day8), EEN (day1-15)

Outcomes

Primary Outcome Measures

changes in hemoglobin
changes in albumin and prealbumin in g/L
changes in lymphocyte count in 10^9/L

Secondary Outcome Measures

rate of clinical remission
HBI score ≤ 4

Full Information

First Posted
August 14, 2016
Last Updated
July 22, 2020
Sponsor
The Second Hospital of Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02897661
Brief Title
Washed Microbiota Transplantation Improves Nutritional Status of Patients With Crohn's Disease
Official Title
Washed Microbiota Transplantation Combining Exclusive Enteral Nutrition Contribute to Nutritional Improvement of Patients With Crohns' Disease
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (undefined)
Primary Completion Date
August 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Second Hospital of Nanjing Medical University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Diseases
Keywords
fecal microbiota transplantation, exclusive enteral nutrition, washed microbiota transplantation, malnutrition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Early WMT and EEN
Arm Type
Experimental
Arm Description
WMT (day1), EEN (day1-15)
Arm Title
Late WMT and EEN
Arm Type
Experimental
Arm Description
WMT (day8), EEN (day1-15)
Intervention Type
Procedure
Intervention Name(s)
WMT
Intervention Description
Washed microbiota transplantation (WMT) through mid-gut
Intervention Type
Dietary Supplement
Intervention Name(s)
EEN
Intervention Description
Exclusive enteral nutrition (EEN) through feeding tube
Primary Outcome Measure Information:
Title
changes in hemoglobin
Time Frame
Day 8 and day 15
Title
changes in albumin and prealbumin in g/L
Time Frame
Day 8 and day 15
Title
changes in lymphocyte count in 10^9/L
Time Frame
Day 8 and day 15
Secondary Outcome Measure Information:
Title
rate of clinical remission
Description
HBI score ≤ 4
Time Frame
day 15
Other Pre-specified Outcome Measures:
Title
rate of adverse events
Description
abdominal pain, fever, increased frequency of defecation, etc.
Time Frame
in 1 month following WMT

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Faming Zhang, MD; PHD
Phone
15005160838
Email
fzhang@njmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Faming Zhang, MD; PHD
Organizational Affiliation
Nanjing Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Faming Zhang, MD, PhD
Phone
086-25-58509883
Email
fzhang@njmu.edu.cn

12. IPD Sharing Statement

Citations:
PubMed Identifier
23016828
Citation
Tjellstrom B, Hogberg L, Stenhammar L, Magnusson KE, Midtvedt T, Norin E, Sundqvist T. Effect of exclusive enteral nutrition on gut microflora function in children with Crohn's disease. Scand J Gastroenterol. 2012 Dec;47(12):1454-9. doi: 10.3109/00365521.2012.703234. Epub 2012 Sep 28.
Results Reference
background
PubMed Identifier
25168749
Citation
Cui B, Feng Q, Wang H, Wang M, Peng Z, Li P, Huang G, Liu Z, Wu P, Fan Z, Ji G, Wang X, Wu K, Fan D, Zhang F. Fecal microbiota transplantation through mid-gut for refractory Crohn's disease: safety, feasibility, and efficacy trial results. J Gastroenterol Hepatol. 2015 Jan;30(1):51-8. doi: 10.1111/jgh.12727.
Results Reference
background
PubMed Identifier
31919742
Citation
Zhang T, Lu G, Zhao Z, Liu Y, Shen Q, Li P, Chen Y, Yin H, Wang H, Marcella C, Cui B, Cheng L, Ji G, Zhang F. Washed microbiota transplantation vs. manual fecal microbiota transplantation: clinical findings, animal studies and in vitro screening. Protein Cell. 2020 Apr;11(4):251-266. doi: 10.1007/s13238-019-00684-8. Epub 2020 Jan 9.
Results Reference
background
PubMed Identifier
34746161
Citation
Xiang L, Yu Y, Ding X, Zhang H, Wen Q, Cui B, Zhang F. Exclusive Enteral Nutrition Plus Immediate vs. Delayed Washed Microbiota Transplantation in Crohn's Disease With Malnutrition: A Randomized Pilot Study. Front Med (Lausanne). 2021 Oct 22;8:666062. doi: 10.3389/fmed.2021.666062. eCollection 2021.
Results Reference
derived

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

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