This is a randomized controlled trial to explore the efficacy of antibiotic pretreatment on the efficacy of WMT in the treatment of chronic constipation in adults: a multi-center, randomized, placebo-controlled clinical study
All included in the standard but do not accord with standard of any rule out subjects will be included in this study. Demographic characteristics, complete spontaneous bowel movements(CSBM), Constipation assessment scale (CAS), Patient-Assessment of Constipation Quality Of Life(PAC-QOL) and clinical outcomes were collected. After the treatment, the efficacy and safety were evaluated during the follow-up period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
96
Patients will receive three consecutive enemas of ornidazole 0.5g+50ml saline through the TET tube, followed by WMT treatment once daily for a duration of 3 days
Patients will receive three consecutive enemas of placebo of equal volume through the TET tube, followed by WMT treatment once daily for a duration of 3 days
Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Response rate of complete spontaneous bowel movements(CSBM)
Overall CSBM respondents defined in the study of drug treatment in patients with the number of weeks of at least 50% of the time meet the CSBM weeks response week (4/8). Response was defined as a CSBM of at least three times in the week and an increase of at least one CSBM from baseline. CSBM was defined as the number of voluntary bowel movements with complete defecation sensation without taking remedial laxatives or manual assistance.
Time frame: One-week, Four-week and Eight-week post-WMT
The extent of change observed in Constipation assessment scale (CAS) of participants
The CAS consisted of 8 items, including abdominal distension, changes in exhaust volume, decreased frequency of defecation, watery stool, rectal obstruction or pressure, rectal pain during defecation, thinness of stool, and unsuccessful defecation. Each item was scored from 0 to 2 according to the severity of symptoms. Each item score was summed, with 0 as no constipation and 16 as the most severe constipation.
Time frame: One-week, Four-week and Eight-week post-WMT
The extent of change observed in Patient-Assessment of Constipation Quality Of Life(PAC-QOL)of participants
The Constipation Quality of Life Scale (PAC-QOL) contains 28 items, including physical discomfort, anxiety, psychosocial discomfort, and satisfaction. It reflects the impact of constipation on daily life in the past two weeks.
Time frame: One-week, Four-week and Eight-week post-WMT
The extent of change observed in stool properties of participants
Bristol stool form scale(BSFS) was used, which can be divided into seven types.
Time frame: One-week post-WMT
Rate of Adverse Events
The rate of adverse events after antibiotic pretreatment
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Time frame: One-week, Four-week and Eight-week post-WMT