Irritable Bowel Syndrome
Conditions
Keywords
diarrhea, abdominal pain
Brief summary
This study is a withdrawal randomized clinical trail to evaluate the clinical efficacy and safety of 1.1 chemical drugs N-acetyl glucosamine on Chinese IBS-D patients coming from four centers in chongqing. 180 IBS-D patients in this research are accord with the Rome III diagnostic criteria, screening/import period pain intensity scores of the NRS week mean value are 3.0 plus and the days which at least more than one time a stool type are 6 or 7 type over 2 days/week. Test cycle includes screening/import period (2 weeks), open treatment period (8 weeks), a double-blind placebo-controlled randomized withdrawal period (8 weeks), the main outcome measures are pain intensity (NRS score 11 point scale) and stool type ( Bristol type). And secondary endpoints included overall symptoms sensory scores, defecation frequency, abdominal distension, mucous stool and quality of life parameters (IBS-36 scale). After the end of the treatment period, the participants whose pain intensity and stool type are effective subjects into a randomized withdrawal period, analysis and comparison of the difference between treatment group and placebo group withdrawal rate and curative effect index score reduces.
Interventions
DRUGplacebo
Sponsors
Third Military Medical University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Man or woman, aged 18 to 65 years, inclusive. * Based on the Roman III diagnostic criteria for diagnosis of IBS-D subjects, recurrent abdominal pain or discomfort (hard to describe the discomfort of pain), monthly attack within the past 3months at least 3 days. With two or more of the following three kinds of symptoms: At least a portion of the time abdominal pain or defecate increase when discomfort. At least a portion of the time abdominal pain or the row of loose stools when discomfort. At least a portion of the time abdominal pain or discomfort improved after defecation. Symptoms for at least 6 months before diagnosis * Screening/import period pain intensity scores of the NRS week mean value are 3.0 plus and the days which at least more than one time a stool type are 6 or 7 type over 2 days/week. * Voluntarily signed the informed consent form
Exclusion criteria
* The absorption of any known adverse * History of gastrointestinal surgery ( not including appendectomy) * History of organic gastrointestinal diseases: IBS, cancer etc. * History of chronic diseases: anemia (hemoglobin\<90g/L), pulmonary tuberculosis, diabetes or cardiovascular, liver, kidney, brain, and hematopoietic system and other serious diseases and psychiatric patients, AST(aspartate aminotransferase), ALT (alanine aminotransferase)\> 1.5 times, BUN (blood urea nitrogen)\> 1.2 times, Cr \> 1.0 times normal. * The disease of lactose intolerance, gallstones, endometriosis, easily confused with IBS symptoms of ; * Progressive weight loss; * Concomitant medication is unable to stop but affect the gastrointestinal movement and function in the experiment, such as antibiotic drugs, the drugs of regulating the intestinal microecology; * Concomitant medication use continuously for more than a week but affect the gastrointestinal movement and function in the experiment, such as parasympathetic inhibitors, nondepolarizing agent, antidiarrheal, opioid formulation, etc; * Other researchers think not suitable for the list;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Abdominal Pain Intensity | one and a half years | As measured by numerical rating scale |
| Stool Consistency | one and a half years | As measured by Bristol ' s scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| abdominal distension | one and a half years | As measure by patient reported outcome measures |
| General symptoms feel grading | one and a half years | As measure by patient reported outcome measures |
| life quality parameters | one and a half years | As measure by healthy survey, SF-36 |
| mucous stool | one and a half years | As measure by patient reported outcome measures |
| defecation frequency | one and a half years | As measure by patient reported outcome measures |
Countries
China
Contacts
Primary ContactJunkang Liu, Doctor
Backup ContactYanxia Liu, Master
Outcome results
None listed