Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210011, China
NCT Number: NCT06437041
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
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Nanjing, Jiangsu, 210011, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
(1) associated with defecation; (2) changes in defecation frequency; (3) changes in stool characteristics (appearance).
The following symptoms were not included in the diagnostic criteria but supported the diagnosis: (1) abnormal bowel frequency: bowel movements less than 3 times per week or more than 3 times per day; (2) the excrement characters and abnormal: dry bulb dung or hard dung, or paste dung/dilute waste water; (3) bowel effort; (4) Defecation urgency, endless defecation, mucus excretion and abdominal distension.
Diagnostic considerations: (1) Diagnosis should be based on the exclusion of organic diseases; (2) the intestinal symptoms of irritable bowel syndrome has certain characteristics, such as abdominal pain or discomfort with bowel movements, this group of symptoms is different from the other functional bowel disease, such as functional constipation, functional diarrhea, functional abdominal pain). (3) Irritable bowel syndrome often coexists with other functional gastrointestinal disorders.
Exclusion criteria
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.
Other names: washed microbiota transplantation
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
Other names: washed microbiota transplantation
Time frame: One-week, Four-week and Eight-week post-WMT
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 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
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) 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 is a self-rating scale that measures subjective feelings of depression. It contains 20 items and is scored on a 4-point scale.
Contact information is provided by the study sponsor or research team.
Bota Cui
CONTACT
Faming Zhang, PhD
CONTACT
Faming Zhang
Other
Effect of Antibiotic Pretreatment on the Efficacy of WMT in the Treatment of Irritable Bowel Syndrome in Adults: a Multi-center, Randomized, Placebo-controlledClinical Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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