Irritable Bowel Syndrom. Irritable bowel syndrome
Conditions
Interventions
Intervention 1: Intervention group: will receive one synbiotic capsule containing Bacillus coagulans(0.1) g and inulin(0.9 g) per day plus low FODMAP diet for 8 weeks. Intervention 2: Control group: w
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 18-65 years Patients with irritable bowel syndrome, according to gastroenterologist diagnosed according to the ROME- IV criteria (1.Improvement with defecation 2.Onset associated with a change in stool frequency 3.Onset associated with a change in stool form (appearance) At least three days a month, three months a year and no pathological findings in the clinical investigating) lack of any organic intestinal disease(diagnosed by last 5 years ago colonoscopy) and intestinal infections(diagnosed by stool culture). No medical history of chronic gastrointestinal and colorectal disease Absence of any major bowel surgery Absence of regular use of laxatives or antidiarrheal drugs No chronic use of antibiotics, corticosteroids and immunosuppressants No usage of drugs that modifying the digestive motility such as metoclopramide, cisapride, diphenoxylate,… No usage of drugs that increased bleeding of intestinal mucosa such as aspirin, warfarin, heparin,… No history of breast cancer in patient or in first-degree relatives of a person Absence of severe mental or behavioral disorder Absence of nicotine and its derivatives use in last 6 monthsNo usage of NSAIDs and aspirin in last week(influence on gut permeability)
Exclusion criteria
Exclusion criteria: Life threatening symptoms Death Not agree to continue the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Abdominal pain intensity. Timepoint: Beginning and end of study. Method of measurement: Questionaire.;Abdominal pain frequency. Timepoint: Beginning and end of study. Method of measurement: Questionaire.;Abdominal distension. Timepoint: Beginning and end of study. Method of measurement: Questionaire.;Satisfaction with bowel habits. Timepoint: Beginning and end of study. Method of measurement: Questionaire.;Interference with community function. Timepoint: Beginning and end of study. Method of measurement: Questionaire.;Defecation frequency. Timepoint: Beginning and end of study. Method of measurement: Questionaire.;Defecation consistency. Timepoint: Beginning and end of study. Method of measurement: Questionaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient-rated Severity score. Timepoint: Begining and end of the study. Method of measurement: Questionare.;IBS-SSS. Timepoint: Begining and end of the study. Method of measurement: Questionare.;IL-6. Timepoint: Begining and end of the study. Method of measurement: Enzymatic method using a kit.;INF-?. Timepoint: Begining and end of the study. Method of measurement: Enzymatic method using a kit. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAzita Hekmatdoost
Shahid Beheshti University of Medical Sciences
Outcome results
None listed