Clinical Trials of N-acetyl Glucosamine Capsule for IBS-D Treatment
- Conditions
- Irritable Bowel Syndrome
- Interventions
- Drug: Starch Placebo
- Registration Number
- NCT02504060
- Lead Sponsor
- Third Military Medical University
- Brief Summary
This study is a randomized double-blind placebo-controlled clinical trail to evaluate the clinical efficacy and safety of 1.1 chemical drugs N-acetyl-D-glucosamine on Chinese IBS-D patients coming from thirty- six centers in Chinese. 720 IBS-D patients (360 for treatment group, 360 for placebo group) in this research are accord with the Rome III diagnostic criteria, screening/import period pain intensity scores of the NRS(numerical rating scale) 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 (12 weeks), follow-up period (2 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, defecation urgency and quality of life parameters (IBS-QOL scale).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 720
- Voluntarily signed the informed consent form.
- 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 accompanied with abdominal discomfort or not, 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 per week.
- During the screening period，patients should answer the questions of electronic log completely following the requirements for 10days or more.
- Patients are willing to stop drugs for abdominal symptoms or diarrhea which are in violation of the scheme, and take medicine prescribed in the scheme.
- Patients agree to not change the lifestyle significantly that may affect the symptoms of IBS-D from signing up the Informed Consent Form to the last experiment.
- The illness recured after a normal colonoscopy report within one year that was provided by this hospital or a grade first class teaching hospital, include polyp of colon (less than 3mm,the number of less than 5) patients who taked therapeutic endoscopy and recurrenced within one year; or those that get a normal colonoscopy report in this hospital or a grade first class teaching hospital before screening but have a history of bowel preparation, should be chosen when next attack.
- History of organic gastrointestinal diseases: Chronic pancreatitis (cp), inflammatory bowel disease, intestinal tuberculosis, malabsorption syndrome, celiac disease, gastrointestinal tumor, or other organic diseases etc.
- History of abdominal and pelvic surgery ( not including appendectomy and intestinal polyposis (<3mm) after treatment within one year ).
- The non-intestinal disease of digestive system such as Peptic ulcer, tuberculous peritonitis, cirrhosis etc.
- Heart, lung, kidney and other important organs have severe lesions, immune regulatory disease, metabolic disease (diabetes, thyroid disease) or malignant tumor, reproductive system diseases such as ovarian cysts, endometriosis, etc.
- Laboratory tests or Electrocardiogram were significantly abnormal, and judging by the researchers may damage the patient safety or successful completion of the clinical research:
Male hemoglobin <120g/L, female hemoglobin <100g/L;
Male serum creatinine≥133umol/L, female serum creatinine≥124umol/L; or creatinine clearance rate≤60ml/min;
Chronic liver disease and/or abnormal liver function, defined as AST (aspartate aminotransferase) > 1.5 x ULN (Upper Limit Of Normal) and/or ALT (alanine aminotransferase) > 1.5 x ULN and/or total bilirubin > 1.5x ULN;
- Serious psychiatric patients( Hamilton Depression Scale scores>20).
- History of drug abuse or alcohol abuse.
- Allergic to this study drug.
- Concomitant medication is unable to stop or use continuously for more than a week but affect the gastrointestinal movement and function in the experiment, such as antibiotic drugs, the drugs of regulating the intestinal microecology, parasympathetic inhibitors, muscle relaxants, antidiarrheal, opiates, etc.
- Do not fill in the electronic log of one week before entering the group (-1 week) completely.
- Pregnant or lactating women
- Is participating in clinical trials or have finished it less than 3 months.
- Other researchers think not suitable for the list.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Starch capsule Starch Placebo During the 12- weeks treatment phase of the study, the daily dose of 3 tablets will be taken 30 minutes after breakfast, lunch and supper. N-acetyl-D-glucosamine N-acetyl-D-glucosamine During the 12- weeks treatment phase of the study, the daily dose of 100mg\*3 (3 tablets) will be taken 30 minutes after breakfast, lunch and supper.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method General symptoms feel grading 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
abdominal distension one and a half years As measure by patient reported outcome measures
Defecation urgency 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
Trial Locations
- Locations (1)
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China