Standardized Fecal Microbiota Transplantation for Crohn&Apos;s Diseases
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorThe Second Hospital of Nanjing Medical University
About this trial
The gut microbiota is considered to constitute a "microbial organ" which has pivotal roles in the intestinal diseases and body's metabolism. Evidence from animal and human studies strongly supports the link between intestinal bacteria and inflammatory bowel diseases (IBD). Dozens of studies reported its efficacy in treatment of severe Clostridium difficile colitis. Preliminary studies using fecal microbiota transplantation (FMT) for Ulcerative Colitis (UC), Crohn's diseases (CD), irritable bowel syndrome (IBS) and constipation have also met with some success. However, the results on CD is very limited. This marks the initial step in exploring the potential efficacy of fecal bacteriotherapy for CD. The investigators aim to evaluate the effectiveness, durability, and safety of FMT in a cohort of at least 500 patients with CD over a ten-year period
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
FMT
Procedure/SurgeryStandard FMT
Treatment groups
800 Participants
are divided into 2 treatment groupsGroup A: Fecal microbiota transplantationExperimental treatment 1 intervention
Group B: Traditional treatmentsNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Clinical remission
Clinical remission defined as HBI score ≦ 4. For patients with complications such as intestinal obstruction, Clinical remission can be defined as obstruction improvement. The endpoint of follow-up is the time of clinical recurrence.
Time frame
Up to one yearSecondary outcomes
1
Costs
Social and medical costs
Time frame
Up to one year2
Adverse events
All possible adverse events:fever,abdominal pain,infectious diseases and others
Time frame
During FMT and ten years after FMT3
Sleep quality
evaluated by Pittsburgh Sleep Quality Index (PSQI), with a score range of 0 to 21. Higher PSQI score indicates poorer sleep quality. Insomnia Severity Index (ISI), with a score range of 0 to 28. Higher ISI score indicates more severe insomnia.
Time frame
before FMT, 1 month after FMT, 12 weeks after FMT4
Fatigue
evaluated by Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), with a score range of 0 to 52. Higher FACIT-F score indicates lower levels of fatigue and better quality of life.
Time frame
before FMT, 1 month after FMT, 12 weeks after FMTSponsors and contacts
Click on the lead sponsor to view all of their trials.
The Second Hospital of Nanjing Medical University
Lead sponsor
The Affiliated Huaian NO.1 People's Hospital of Nanjing Medical University
Collaborator
The First Affiliated Hospital of Air Force Medicial University
Collaborator
Source ClinicalTrials.gov