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

NCT02897661 | Unknown

• 1 other identifier: NEU-CN-160814
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohn's Diseases

Keywords

fecal microbiota transplantation; exclusive enteral nutrition; washed microbiota transplantation; malnutrition

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• rate of clinical remission

  day 15

Other Outcomes (1)

• rate of adverse events

  in 1 month following WMT

Study Arms (2)

Early WMT and EEN

EXPERIMENTAL

WMT (day1), EEN (day1-15)

Procedure: WMT; Dietary Supplement: EEN

Late WMT and EEN

EXPERIMENTAL

WMT (day8), EEN (day1-15)

Procedure: WMT; Dietary Supplement: EEN

Interventions

WMT PROCEDURE

Washed microbiota transplantation (WMT) through mid-gut

Early WMT and EEN; Late WMT and EEN

EEN DIETARY_SUPPLEMENT

Exclusive enteral nutrition (EEN) through feeding tube

Early WMT and EEN; Late WMT and EEN

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Second Hospital of Nanjing Medical University: lead

Study Sites (1)

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

Nanjing, Jiangsu, 210011, China

RECRUITING

Related Publications (4)

• 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.

  PMID: 23016828 BACKGROUND

• 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.

  PMID: 25168749 BACKGROUND

• 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.

  PMID: 31919742 BACKGROUND

• 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.

  PMID: 34746161 DERIVED

MeSH Terms

Conditions

Crohn Disease; Malnutrition

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Faming Zhang, MD; PHD

  Nanjing Medical University

  STUDY CHAIR

Central Study Contacts

Faming Zhang, MD; PHD

CONTACT

15005160838; fzhang@njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, Gastroenterology

Study Record Dates

• First Submitted: August 14, 2016
• First Posted: September 13, 2016
• Study Start: August 1, 2016
• Primary Completion: August 1, 2020
• Study Completion: December 1, 2020
• Last Updated: July 23, 2020

Record last verified: 2020-07

Locations

CN (1)