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Status unknownNCT02897661Updated Jul 23, 2020

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

An interventional study of WMT and EEN in Crohn's Diseases, sponsored by The Second Hospital of Nanjing Medical University. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-07-23.

Sponsored by The Second Hospital of Nanjing Medical University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

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Conditions studied

  • Crohn's Diseases

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Keywords

  • fecal microbiota transplantation
  • exclusive enteral nutrition
  • washed microbiota transplantation
  • malnutrition
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In context

Crohn Disease

1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.

This study's planned enrollment of 30 is below the median of 66 across 1,188 interventional studies indexed under Crohn Disease.

Browse Crohn Disease studies →

Lead sponsor

The Second Hospital of Nanjing Medical University is the lead sponsor of 67 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Early WMT and EEN

    WMT (day1), EEN (day1-15)

    Procedure: WMT · Dietary Supplement: EEN

  • Experimental
    Late WMT and EEN

    WMT (day8), EEN (day1-15)

    Procedure: WMT · Dietary Supplement: EEN

Interventions

  • ProcedureWMT

    Washed microbiota transplantation (WMT) through mid-gut

  • Dietary supplementEEN

    Exclusive enteral nutrition (EEN) through feeding tube

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What researchers measure

Primary outcomes

  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 outcomes

  1. rate of clinical remission

    HBI score ≤ 4

    Time frame: day 15

Other outcomes

  1. rate of adverse events

    abdominal pain, fever, increased frequency of defecation, etc.

    Time frame: in 1 month following WMT

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Study locations

1 of 1 sites recruiting
  • Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
    Nanjing, Jiangsu 210011, China
    Recruiting
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References and documents

Publications

  • 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. PubMed 23016828 ↗
  • 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. PubMed 25168749 ↗
  • 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. PubMed 31919742 ↗
  • 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. PubMed 34746161 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 23, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02897661
Lead sponsor
The Second Hospital of Nanjing Medical University
Responsible party
Faming Zhang (Associate professor, Gastroenterology, The Second Hospital of Nanjing Medical University) — Principal investigator
First posted
Sep 13, 2016
Start date
Aug 2016
Primary completion
Aug 2020 (estimated)
Completion
Dec 2020 (estimated)
Last update
Jul 23, 2020

Study contacts

Faming Zhang, MD; PHD
Contact
fzhang@njmu.edu.cn
15005160838
Faming Zhang, MD; PHD
study chair · Nanjing Medical University
View the source record on ClinicalTrials.gov ↗

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