Constipation
Conditions
Brief summary
Chronic constipation is a prevalent, burdensome gastrointestinal disorder whose treatment remains challenging. There exist effective pharmacological therapies for chronic constipation, however, many patients do not well respond to current medications. Evidence suggests that disturbance in the gastrointestinal microbiota may be implicated in chronic constipation. Although, E.coli Nissle 1917 (Mutaflor®) has been used for chronic constipation, there are limited data regarding the efficacy of E.coli Nissle 1917 (Mutaflor®) in these patients. Therefore, this study aimed to investigate the efficacy of E.coli Nissle 1917 (Mutaflor®) in patients with chronic constipation.
Interventions
DRUGE. coli Nissle 1917(Mutaflor®)
DRUGPlacebo
Sponsors
Keimyung University Dongsan Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Adult male or female outpatients aged from 20 to 75 years old. * Patients meet International Congress of Gastroenterology (ROME III) clinical criteria for constipation\*: A. Must include two or more of the following: 1. Straining in \> 1/4 defecations; 2. Lumpy or hard stools \> 1/4 defecations; 3. Sensation of incomplete evacuation in 1/4 defecations; 4. Sensation of anorectal obstruction/blockage in \> 1/4 defecations; 5. \<3 defecations/week. B.Loose stools are rarely present without the use of laxatives. C.There are insufficient criteria for irritable bowel syndrome. \*Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis.
Exclusion criteria
* Pregnant or lactating woman * Known organic gastrointestinal disease * Subjects who diagnosed advanced adenoma within 3 years * Prior gastrointestinal surgery (except appendectomy, herniotomy) * Subjects who diagnosed irritable bowel syndrome * Use of one or more of listed medications within 2 weeks (Laxative, Metoclopramide, Domperidone, Itopride, Levosulpride, Cisapride, Mosapride, Tegaserod, Prucalopride, Renzapride, Erythromycin, buspirone, Sumatriptan, Alosetron, Cilansetron, ondansetron, Citalopram, Paroxetine, Baclofen, Sildenafil, Nitroglycerin) * Subjects who diagnosed lactulose malabsorption * Subjects who diagnosed liver cirrhosis, severe congestive heart failure, severe renal insufficiency, uncontrolled hypertension, endocrine disorder, metabolic disorder, prior malignancy, immune deficiency * Suspected obstruction, gastric retention, ileus, perforation, fecal impaction or inflammatory bowel disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relief of constipation defined by improvement of complete spontaneous bowel movements(CSBMs/week) | 28days | Subjects will report symptoms by questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of average number of CSBMs/week | 28days | Subjects will report symptoms by questionnaire |
| The time to 1st CSBM or SBM | 28days | Subjects will report symptoms by questionnaire |
| Improvement of constipation related quality of life | 28days | Subjects will report symptoms by questionnaire |
| Improvement of constipation related symptom | 28days | Subjects will report symptoms by questionnaire |
Countries
South Korea
Outcome results
None listed