Effect of Bacillus coagulans and inulin compared with low FODMAP diet in treatment of IBS

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 50

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

Life threatening symptoms
Death
Not agree to continue the study

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.