Crohn's Diseases
Conditions
Keywords
fecal microbiota transplantation, exclusive enteral nutrition, washed microbiota transplantation, malnutrition
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.
Interventions
Sponsors
The Second Hospital of Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
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.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| rate of clinical remission | day 15 | HBI score ≤ 4 |
Other
| Measure | Time frame | Description |
|---|---|---|
| rate of adverse events | in 1 month following WMT | abdominal pain, fever, increased frequency of defecation, etc. |
Countries
China
Contacts
Primary ContactFaming Zhang, MD; PHD
Outcome results
None listed