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

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ClinicalTrials.gov Identifier: NCT02897661
Recruitment Status : Recruiting
First Posted : September 13, 2016
Last Update Posted : July 23, 2020
Sponsor:
Information provided by (Responsible Party):
Faming Zhang, 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.


Condition or disease Intervention/treatment Phase
Crohn's Diseases Procedure: WMT Dietary Supplement: EEN Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Washed Microbiota Transplantation Combining Exclusive Enteral Nutrition Contribute to Nutritional Improvement of Patients With Crohns' Disease
Study Start Date : August 2016
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
Experimental: Early WMT and EEN
WMT (day1), EEN (day1-15)
Procedure: WMT
Washed microbiota transplantation (WMT) through mid-gut

Dietary Supplement: EEN
Exclusive enteral nutrition (EEN) through feeding tube

Experimental: Late WMT and EEN
WMT (day8), EEN (day1-15)
Procedure: WMT
Washed microbiota transplantation (WMT) through mid-gut

Dietary Supplement: EEN
Exclusive enteral nutrition (EEN) through feeding tube




Primary Outcome Measures :
  1. changes in hemoglobin [ Time Frame: Day 8 and day 15 ]
  2. changes in albumin and prealbumin in g/L [ Time Frame: Day 8 and day 15 ]
  3. changes in lymphocyte count in 10^9/L [ Time Frame: Day 8 and day 15 ]

Secondary Outcome Measures :
  1. rate of clinical remission [ Time Frame: day 15 ]
    HBI score ≤ 4


Other Outcome Measures:
  1. rate of adverse events [ Time Frame: in 1 month following WMT ]
    abdominal pain, fever, increased frequency of defecation, etc.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02897661


Contacts
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Contact: Faming Zhang, MD; PHD 15005160838 fzhang@njmu.edu.cn

Locations
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China, Jiangsu
Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University Recruiting
Nanjing, Jiangsu, China, 210011
Contact: Faming Zhang, MD, PhD    086-25-58509883    fzhang@njmu.edu.cn   
Sponsors and Collaborators
The Second Hospital of Nanjing Medical University
Investigators
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Study Chair: Faming Zhang, MD; PHD Nanjing Medical University
Publications:
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Responsible Party: Faming Zhang, Associate professor, Gastroenterology, The Second Hospital of Nanjing Medical University
ClinicalTrials.gov Identifier: NCT02897661    
Other Study ID Numbers: NEU-CN-160814
First Posted: September 13, 2016    Key Record Dates
Last Update Posted: July 23, 2020
Last Verified: July 2020
Keywords provided by Faming Zhang, The Second Hospital of Nanjing Medical University:
fecal microbiota transplantation
exclusive enteral nutrition
washed microbiota transplantation
malnutrition
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases