This is a randomized controlled trial to explore the efficacy of antibiotic pretreatment on the efficacy of WMT in the treatment of Irritable bowel syndrome 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, Gastrointestinal Symptoms Rating Scales(GSRS),IBS Symptom Severity Scaleand(IBS-SSS) 、Pittsburgh Sleep Quality Index(PSQI)、Self-rating Anxiety Scale(SAS)、Self-rating Depression Scale(SDS)and clinical outcomes will be collected. After the treatment, the efficacy and safety will be 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
Gastrointestinal Symptoms Rating Scales(GSRS)
Gastrointestinal Symptom Rating Scale (GSRS) included 5 items: abdominal pain (3 items), reflux (2 items), dyspepsia (4 items), diarrhea (3 items) and constipation (3 items). The severity of each symptom was assessed using a 4-point Likert scale, with a score of 0 indicating no symptoms and a score of 3 indicating very severe symptoms.
Time frame: One-week, Four-week and Eight-week post-WMT
IBS Symptom Severity Scaleand(IBS-SSS)
IBS symptom severity scale (IBS-SSS) consists of five items, which assess the severity of abdominal pain, the frequency of abdominal pain, the degree of abdominal distention and discomfort, the satisfaction of bowel habit and behavior, and the impact of intestinal symptoms on life. Each item was divided into 5 levels, increasing by 20 points, and the total score was 500 points. A score of 75 to 175 is mild, 176 to 300 is moderate, and more than 300 is severe.
Time frame: One-week, Four-week and Eight-week post-WMT
Pittsburgh Sleep Quality Index(PSQI)
PSQI was used to assess the sleep quality of the subjects in the last month. It consisted of 19 self-rated items and 5 patient-rated items.
Time frame: One-week, Four-week and Eight-week post-WMT
Self-rating Anxiety Scale(SAS)
Self-rating anxiety Scale (SAS) is a self-rating scale used to evaluate the subjective feelings of patients with anxiety. It contains 20 items and is divided into 4 grades.
Time frame: One-week, Four-week and Eight-week post-WMT
Self-rating Depression Scale(SDS)
Self-rating Depression Scale,SDS is a self-rating scale that measures subjective feelings of depression. It contains 20 items and is scored on a 4-point scale.
Time frame: One-week, Four-week and Eight-week post-WMT
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