Irritable bowel syndrome with predominant diarrhea
Conditions
Interventions
Duloxetine Group:Duloxetine capsules + simulated Escitalopram placebo tablets
Escitalopram group:Escitalopram tablets + simulated duloxetine placebo capsules
Placebo group:Simulated duloxetine placebo capsule + simulated Escitalopram placebo tablet
Sponsors
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Age range from 18 ~ 65 years old, male and female. (2) Patients who meet the diagnostic criteria of Rome IV IBS-D, recurrent abdominal pain, at least 1 day per week in the past 3 months, accompanied by two or more of the following: 1) related to defecation (refers to abdominal pain before, during or just after defecation); 2)associated with an increase of bowel movements; 3) assocaited with changes in stool form (mushy and watery), and with or without abdominal discomfort and bloating. Symptoms appeared at least 6 months before diagnosis, and the above criteria were met in the last 3 months. (3) Organic diseases were excluded by colonoscopy, abdominal ultrasound or CT in the past 1 year; In the past 3 months, there were no obvious abnormalities in blood routine and liver and kidney function tests. (4) IBS symptom Severity score (IBS-SSS) >=175 (IBS symptom severity is at least moderate). (5) During the 1-week baseline screening period, the heaviest abdominal pain score was =4 points (using the 0-10 VAS scale) for at least 1 day. (6) In the past 1 year, conventional treatment for IBS accumulated =8 weeks, which was ineffective (meaning that symptoms were reduced by less than 50%, that is, refractory IBS), and/or measured by the Hamilton Anxiety Scale (HAMA) and Hamilton Depression Scale (HAMD). Anxiety (HAMA>=14) and/or depression (HAMD>=17) were assessed. (7) Duloxetine and Escitalopram have not been used in the past. (8) Patients participating in the therapeutic mechanism study should also meet the following conditions: 1) no metal in the body, including pacemakers, metal dentures, metal debris, etc.; 2) No contraindications for MRI, including claustrophobia; 3) Right-handedness: It is determined according to the "Chinese handedness Classification Standard" scale . (9) Patients have the ability to cooperate with the relevant contents of the study and voluntarily sign the informed consent.
Exclusion criteria
Exclusion criteria: (1) Patients with gastrointestinal and abdominal organic diseases, such as inflammatory bowel disease, celiac disease, intestinal obstruction, peritonitis, peptic ulcer, cholelithiasis with biliary colic, endometriosis, gastrointestinal and abdominal and pelvic malignancies, etc. (2) History of abdominal and pelvic surgery (except appendectomy, cesarean section without complications, endoscopic removal or resection of gastrointestinal polyps for more than 3 months). (3) Subjects with other systemic diseases, including serious diseases of the heart, lungs,liver, kidney and other organs and metabolic diseases, immune diseases; Blood routine test and liver and kidney function tests were abnormal before enrollment. (4) Subjects with diagnosis of anxiety, depression and other mental disorders. (5) A history of drug or alcohol abuse. (6) Pregnant or lactating women, or those who have a family plan recently. (7) Less than 3 months after participating in or completing other clinical trials. (8) Other candidates deemed unsuitable by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical efficacy rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients with significant relief of IBS symptoms for more than 6 weeks during 12 weeks medication;IBS-SSS scores and changes from baseline;HAMA and HAMD scores;Irritable Bowel Syndrome Quality of Life (IBS-QOL);Therapeutic mechanism of two neuromodulators;Efficacy and patient compliance of different neuromodulators; | — |
Countries
China
Contacts
Public ContactFang Xiucai
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed