Washed Microbiota Transplantation Improves Nutritional St... | NCT02897661

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

NCT02897661

Sponsor

The Second Hospital of Nanjing Medical University

Status

Unknown status

Last Update Posted

Jul 23, 2020Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Crohn's Diseases

Interventions

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2016

Primary Completion Date

Aug 2020Estimated

Completion Date

Dec 2020Estimated

First Submitted Date

Aug 14, 2016

First Submission Date that Met QC Criteria

Sep 7, 2016

First Posted Date

Sep 13, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 22, 2020

Last Update Posted Date

Jul 23, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Faming Zhang, Associate professor, Gastroenterology, The Second Hospital of Nanjing Medical UniversityPrincipal Investigator

Lead Sponsor

The Second Hospital of Nanjing Medical UniversityOTHER

Collaborators

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
WMT	Procedure	Washed microbiota transplantation (WMT) through mid-gut	Early WMT and EEN Late WMT and EEN

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
rate of clinical remission	HBI score ≤ 4	day 15

Other Outcomes

Measure	Description	Time Frame
rate of adverse events	abdominal pain, fever, increased frequency of defecation, etc.	in 1 month following WMT

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Faming Zhang, MD; PHD	Contact	15005160838		fzhang@njmu.edu.cn

Overall Officials

Name	Affiliation	Role
Faming Zhang, MD; PHD	Nanjing Medical University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University	Recruiting	Nanjing	Jiangsu	210011	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23016828	Background	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.
25168749	Background

ID	Term
D003424	Crohn Disease
D044342	Malnutrition

ID	Term
D015212	Inflammatory Bowel Diseases
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases