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
Male and female, aged ≥18 years old, provided written informed consent;
Presence of outlet obstruction and constipation, such as rectal mucosal prolapse
Combined with the results of colonoscopy in the past 24 months, those with intestinal stenosis caused by organic lesions of the digestive tract (such as tumor, inflammation, anal fissure, Crohn's disease, ulcerative colitis, intestinal adhesion, intestinal tuberculosis, etc.) and constipation;
Constipation caused by other systemic diseases involving the digestive tract, such as nervous system diseases (such as Parkinson's disease, spinal cord injury, multiple sclerosis, etc.), muscle diseases (such as amyloidosis, dermatomyositis, etc.), mental disorders (such as depression, etc.), metabolic and endocrine disorders (such as diabetes, hypothyroidism, etc.) or opioids, etc.
Has a history of abdominal pelvic surgery, but after cystic resection, cesarean section, does not appear after appendectomy postoperative intestinal complications, and intestinal polyps except after treatment;
Parallel
Ornidazole
DrugPatients 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
Placebo
DrugPatients 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
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.
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.
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.
The extent of change observed in stool properties of participants
Bristol stool form scale(BSFS) was used, which can be divided into seven types.
Rate of Adverse Events
The rate of adverse events after antibiotic pretreatment
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Faming Zhang
Lead sponsor
The Second Hospital of Nanjing Medical University
Sponsor institution
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