NCT02897661

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: The Second Hospital of Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	WMT	Washed microbiota transplantation (WMT) through mid-gut
DIETARY_SUPPLEMENT	EEN	Exclusive enteral nutrition (EEN) through feeding tube

Timeline

• Start date: 2016-08-01
• Primary completion: 2020-08-01
• Completion: 2020-12-01
• First posted: 2016-09-13
• Last updated: 2020-07-23

Locations

1 site across 1 country: China