Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years - 65 Years|
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.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|The Second Hospital of Nanjing Medical University|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Faming Zhang, MD; PHD|
|Principal Investigator Affiliation||Nanjing Medical University|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
Experimental: Early WMT and EEN
WMT (day1), EEN (day1-15)
Experimental: Late WMT and EEN
WMT (day8), EEN (day1-15)
Procedure: - WMT
Washed microbiota transplantation (WMT) through mid-gut
Dietary Supplement: - EEN
Exclusive enteral nutrition (EEN) through feeding tube
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.