Irritable Bowel Syndrome. Irritable colon
Conditions
Interventions
Intervention 1: Group A receiving Supplement in form of 50000 IU cholecalciferol biweekly for 6 weeks in addition to 40 milligram placebo capsules similar to soy isoflavones including starch 2 capsul
Treatment - Drugs
Group D receiving oral Placebo in similar form to soy isoflavones (diadzein, genstein, glycetin) supplement including starch (2 capsules per day) for 6 weeks in addition to 50000 IU cholecalciferol su
Group A receiving Supplement in form of 50000 IU cholecalciferol biweekly for 6 weeks in addition to 40 milligram placebo capsules similar to soy isoflavones including starch 2 capsules per day for 6
Group B receiving Supplement in form of 40 milligrams soy isoflavones (diadzein, genstein, glycetin) per day (2 capsules of 20 milligrams) for 6 weeks in addition to supplement of cholecalciferol (vi
Group C receiving Placebo in similar form of cholecalciferol supplement biweekly for 6 weeks in addition to 40 milligrams placebo in similar form of soy isoflavones including starch for 6 weeks
Sponsors
National Nutrition and Food Technology Institute
Tehran University of Medical Sciences, Digestive Diseases Research Institute
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: age 18-75 yrs; patients with Irritable Bowel Syndrome (IBS) according to ROME III criteria; BMI 18-25; no intestinal organic diseases; no intestinal infection; no history of chronic gastrointestinal and colorectal diseases; no intestinal major surgery; no regular use of antibiotics, anti-constipation and anti-diarrhea, immune suppressors, metocloperamide, cisaperide, difenoxilate, opium and non-steroidal anti-inflammatory drugs; no pregnancy and lactation; not athlete or bed rest; no history of breast cancer in herself or her family; no severe psychosis Exclusion criteria: use of soy isoflavones or vitamin D one year before the study; use of soy milk or soy nuts during study; diet changes during study; use of artificial sweetener 2 days before study; no desire to complete the study; adverse effect of supplement; pregnancy during study
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Outcomes (pain, flatulence, diarrhea, constipation ). Timepoint: before and after the 6 weeks. Method of measurement: IBS validated Module according to ROME-III criteria. | — |
Secondary
| Measure | Time frame |
|---|---|
| Gut permeability. Timepoint: before and after 6 weeks. Method of measurement: The fecal serin protease.;Antioxidant status. Timepoint: before and after 6 weeks. Method of measurement: Serum total antioxidant capacity.;Inflammation status. Timepoint: before and after 6 weeks. Method of measurement: Serum tumor necrosis factor-alpha. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMahsa Jalili
Nutrition Faculty of Shahid Beheshti University of Medical Sciences
Outcome results
None listed