Efficacy, Safety and Microbiota of Intestinal Microbiota Transplantation for Inflammatory Bowel Diseases
Phase: NA
Conditions: Inflammatory Bowel Disease(IBD)
Sponsor: Zhongshan Hospital Xiamen University

The Effect of Intestinal Microbiota
Transplantation for Inflammatory
Bowel Diseases (IBD)
Date:
2017.05

1.Method
Intestinal microbiota transplantation(IMT) refers to make fecal from the health
into a suspension of microbes through an intelligent bacteria processing system, and
then infuse the suspension into the gastrointestinal tract of patients through naso
intestinal tube, gastroscope, enteroscope or capsule intake which can reconstruct
intestinal microbiota and play the role of treatment without obvious side effect.
2.Plan
1)Patient recruitment
Inclusion Criteria:
•
Standard or conventional medicine treatment ineffective of Inflammatory
Bowel Diseases(IBD) patients
•
IBD patients with recurrent symptoms
•
IBD patients who had drug dependence or recurrence when reduced or
discontinued use
•
Untreated IBD patients who voluntarily received Standardized Intestinal
Microbiota Transplantation(IMT)
•
Written informed consent/assent as appropriate
Exclusion Criteria:
•
IBD patients with contraindications for gastrointestinal endoscopy
•
IBD patients with indication of surgery
•
Moderate and severe renal injuty(serum creatinine>2mg/dL or 177mmol/L),
moderate and severe chronic obstructive pulmonary disease, severe
hypertension, cerebrovascular accident, congestive heart failure, unstable
angina pectoris
•
Other serious diseases that may interfere the recruitment or affect the survival,
such as cancer or acquired immune deficiency syndrome
•
Mentally or legally disabled person
•
Preparing for pregnancy
•
Medical or social condition which in the opinion of the principal investigator
would interfere with or prevent regular follow up
•
Participating in other clinical trials.
Recruit the patients who meet the inclusion criteria, and fail to meet the
exclusion criteria. Introduce this clinical trial to the patients and obtain the informed
consent. Assess the condition of the disease.
2)Arms and Interventions
Randomly divided the patients into experimental arm and control arm and

intervene them as described in the following table.
arms
Assigned interventions
Experimental: Standardized IMT
30 patients with inflammatory bowel
disease ongoing traditional drugs will be
recruited for the study, which taking
intestinal
microbiota
transplant
three
times a week.
Interventions:
Procedure:
Intestinal
Microbiota
Transplantation
Procedure: traditional drugs
intestinal microbiota transplant
Participants in Experimental group
take IMT three times a week.
Drug: traditional drugs such as
Mesalazine\glucocorticoid, All
participants continue his or her therapy.
Traditional drugs
30 patients with inflammatory bowel
disease ongoing traditional drugs will be
recruited for the study
Interventions:
Procedure: traditional drugs such as
Mesalazine\glucocorticoid
Drug: Mesalazine\glucocorticoid
All participants continue his or her
therapy.
3)Outcome Measures
Primary Outcome Measure:
The change of the modified Mayo score
Clinical remission defined as modified Mayo score≦2. Change from baseline
will
be assessed at different time point. The endpoint of follow-up is the time of
clinical
recurrence.
[Time Frame: 1 month, 3 months, 6months，12 months]
Secondary Outcome Measure:
1
The change of CDAI
Clinical remission defined as CDAI (Crohn's disease activity index)
≦150.Change from baseline will be assessed at different time point. The

endpoint of follow-up is the time of clinical recurrence.
[Time Frame: 1 month, 3 months, 6months，12 months]
2
Relief of gastrointestinal symptoms
The onset and duration of gastrointestinal symptoms will be assessed by
"Evaluation Score Table of Gastrointestinal Symptoms". Change from
baseline
will be assessed at different time point.
[Time Frame: 1 month, 3 months, 6months，12 months]
3
Changes of gut microbiota
Alpha and Beta diversity of GI microbiota by High-throughput sequencing
on
baseline line and1 month, 3 months, 6months ,12 months after treatment.
[Time Frame: 1 month, 3 months, 6months]