Irritable Bowel Syndrome
Conditions
Keywords
Fecal microflora, IBS, Sequential treatment, Probiotic, Laxative
Brief summary
the laxative-probiotic sequential treatment might reduce the symptoms of IBS and alter the fecal microbiota of the patients in a more robust manner .
Detailed description
Probiotics can regulate intestinal immunity, repair mucosal barrier, and reportedly exert therapeutic effects on IBS patients. The laxatives could also alter the gut microflora significantly, thus the laxative-probiotic sequential treatment might affect the symptoms and the composition of fecal microbiota in the IBS patients in a more robust manner .
Interventions
DRUGProbiotic Clostridium Butyricum
probiotic:2 tablets/ times, 3 times / day for 2 weeks
DRUGLaxative Polyethylene Glycol
laxative：2000 ml.
Sponsors
Shandong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* the presence of Rome III criteria for IBS ; * Patients scheduled for colonoscopy examination or having negative screening examinations * Aged between 18 and 65 years old
Exclusion criteria
* Antibiotic, probiotic or laxative usage within 4 weeks. * organic gastrointestinal diseases * Severe systematic disease: diabetes mellitus, hepatic, renal or cardiac dysfunction, thyroid disease or tumor etc. * pregnancy or lactation. * previous major or complicated abdominal surgery. * severe endometriosis and dementia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subject's Global Assessment of Relief | 8 months | The SGA (subjective global assessment) of Relief was assessed by answering the following question: Please consider how you felt this past week in regard to your IBS, in particular your overall wellbeing, symptoms and altered bowel habit. Compared to the way you usually felt before entering the study, how would you rate your relief of symptoms during the past week? The scale contained five possible answers: (1) completely relieved, (2) considerably relieved, (3) somewhat relieved, (4) unchanged, or (5) worse. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The changes of symptom scores | 8 months | The symptom score includes abdominal pain, discomfort, bloating, stool frequency, stool consistency according to Bristol stool form scale and defecation urgency，imcomplete，straining. |
| IBS patients'quality of life | 8 months | Quality of life was determined by using IBS-QOL scoring system for patients with IBS. This questionnaire comprises a range of 34 items with response options on a 5-point rating scale. The items contribute to 8 domains as follows: Dysphoria, Interference with activity, Body image, Health worry, Food avoidance, Social reaction, Sexual, Relationship. |
| Composition of Microorganisms in stool | 8 months | Primary coordination of fecal samples' 16s rDNA (ribosomal deoxyribonucleic acid) will be compared between two Groups using Braycurtis distance based Primary coordination analysis (PCoA). |
Countries
China
Outcome results
None listed