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Fecal Microbiota Transplantation Improves Nutritional State of Patients With Crohn's Disease

This study is currently recruiting participants.
See Contacts and Locations
Verified January 2017 by Faming Zhang, The Second Hospital of Nanjing Medical University
Sponsor:
Information provided by (Responsible Party):
Faming Zhang, The Second Hospital of Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT02897661
First received: August 14, 2016
Last updated: January 26, 2017
Last verified: January 2017
  Purpose
Patients with Crohns' disease are always complicated with malnutrition. This trial aimed to assess whether FMT accompanied by enteral nutrition (EN) can make contributions to patients with Crohns' disease.

Condition Intervention Phase
Crohn's Diseases Procedure: FMT Drug: Metronidazole Dietary Supplement: EN Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fecal Microbiota Transplantation Combined Enteral Nutrition Therapy Contribute to Nutritional Improvement of Patients With Crohns' Disease

Resource links provided by NLM:


Further study details as provided by Faming Zhang, The Second Hospital of Nanjing Medical University:

Primary Outcome Measures:
  • changes in nutritional index [ Time Frame: Day 8 ]
    albumin and prealbumin in g/L


Secondary Outcome Measures:
  • changes in nutritional index [ Time Frame: Day 15 ]
    albumin and prealbumin in g/L

  • changes in inflammation markers [ Time Frame: Day 15 ]
    C-reactive protein in mg/L

  • changes in inflammation index [ Time Frame: Day 15 ]
    Erythrocyte Sedimentation Rate in mm/h


Other Outcome Measures:
  • adverse events [ Time Frame: two weeks ]
    aspiration of different gastric content, infection and allergy, etc.


Estimated Enrollment: 60
Study Start Date: August 2016
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MNZ plus Early FMT and EN
Metronidazole+EN (day-3~-1), FMT (day1), EN (day1-14)
Procedure: FMT
fecal microbiota transplantation (FMT) via mid-GI
Drug: Metronidazole
oral adminstration
Other Name: Methyl-5-nitroimidazole-1-ethanol
Dietary Supplement: EN
via nasal feeding tube
Experimental: MNZ plus late FMT and EN
Metronidazole+EN (day-3~-1), FMT (day8), EN (day1-14)
Procedure: FMT
fecal microbiota transplantation (FMT) via mid-GI
Drug: Metronidazole
oral adminstration
Other Name: Methyl-5-nitroimidazole-1-ethanol
Dietary Supplement: EN
via nasal feeding tube
Active Comparator: Early FMT plus EN
EN (day-3~-1), FMT (day1), EN (day1-14)
Procedure: FMT
fecal microbiota transplantation (FMT) via mid-GI
Dietary Supplement: EN
via nasal feeding tube

  Eligibility

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

Inclusion Criteria:

  1. patients aged from 18 to 65, regardless of gender;
  2. moderate to severe active CD patients(CDAI>220),accompanied with malnutrition;
  3. infection status;
  4. patients with high compliance;
  5. suitable for fecal microbiota transplantation and enteral nutrition therapy;
  6. history of safe mesalazine use.

Exclusion Criteria:

  1. severe infection which affected vital signs;
  2. parenteral infection such as urinary tract, lung and so on;
  3. mycobacterium tuberculosis infection;
  4. immunosuppressor or biologicals use within 6 week;
  5. allergic to metronidazole,salicylic acid preparation, etc;
  6. complicated with perianal Crohn's disease, intestinal fistula, intestinal obstruction;
  7. accompanied by any severe disease such as cancer or AIDS;
  8. patients who are in pregnant or going to pregnant;
  9. patients who has disability mentally and physically.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02897661

Contacts
Contact: Faming Zhang, associate chief physician 15005160838 fzhang@njmu.edu.cn

Locations
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
Study Chair: Faming Zhang, associate chief physician Nanjing Medical University
  More Information

Publications:
Responsible Party: Faming Zhang, Associate professor, Gastroenterology, The Second Hospital of Nanjing Medical University
ClinicalTrials.gov Identifier: NCT02897661     History of Changes
Other Study ID Numbers: NEU-CN-160814
Study First Received: August 14, 2016
Last Updated: January 26, 2017

Keywords provided by Faming Zhang, The Second Hospital of Nanjing Medical University:
fecal microbiota transplantation
enteral nutrition

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Metronidazole
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on September 19, 2017