Multicenter Withdrawal Clinical Trials of N-acetyl Glucosamine Capsule for IBS-D Treatment

Study Overview
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Brief Summary
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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.

Official Title
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Multicenter Randomized Withdrawal Clinical Trials of N-acetyl Glucosamine Capsule for Irritable Bowel Syndrome With Diarrhea (IBS-D) Treatment

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Drug: N-acetyl-D-glucosamine
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Starch capsule<br>During the two weeks screening phase of the study, the daily dose of 3 tablets will be taken before breakfast, lunch and supper. | Drug: placebo<br> <br> |
| Experimental: N-acetyl-D-glucosamine<br>During the 8-week treatment phase of the study,the dose of 100mg(3 tablets)per day will be taken. | Drug: N-acetyl-D-glucosamine<br> <br> * Other names: Atysamine (ATSM);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abdominal Pain Intensity | As measured by numerical rating scale | one and a half years | 
| Stool Consistency | As measured by Bristol ' s scale | one and a half years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General symptoms feel grading | As measure by patient reported outcome measures | one and a half years | 
| defecation frequency | As measure by patient reported outcome measures | one and a half years | 
| abdominal distension | As measure by patient reported outcome measures | one and a half years | 
| mucous stool | As measure by patient reported outcome measures | one and a half years | 
| life quality parameters | As measure by healthy survey, SF-36 | one and a half years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diarrhea, abdominal pain