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

Crohn's Diseases Clinical Trial

Official title:

Washed Microbiota Transplantation Combining Exclusive Enteral Nutrition Contribute to Nutritional Improvement of Patients With Crohns' Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02897661
• Other study ID #: NEU-CN-160814
• Status: Recruiting
• Phase: N/A
• Start date: August 2016
• Est. completion date: December 2020

Study information

• Verified date: July 2020
• Source: The Second Hospital of Nanjing Medical University
• Contact: Faming Zhang, MD; PHD
• Phone: 15005160838
• Email: fzhang[@]njmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Diseases

Intervention

Procedure:
• WMT
Washed microbiota transplantation (WMT) through mid-gut

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

Locations

Country	Name	City	State
China	Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The Second Hospital of Nanjing Medical University

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View Citation

Tjellström B, Högberg 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	rate of adverse events	abdominal pain, fever, increased frequency of defecation, etc.	in 1 month following WMT
Primary	changes in hemoglobin		Day 8 and day 15
Primary	changes in albumin and prealbumin in g/L		Day 8 and day 15
Primary	changes in lymphocyte count in 10^9/L		Day 8 and day 15
Secondary	rate of clinical remission	HBI score = 4	day 15