Irritable Bowel Syndrome (IBS)
Conditions
Brief summary
The goal of this clinical trial is to learn if thyme supplement enhances the effects of a low FODAMP diet on reducing clinical symptoms and improving the quality of life of patients with irritable bowel syndrome or not. The main questions it aims to answer are: 1. Does consumption of thyme reduce the severity score of clinical symptoms in patients with irritable bowel syndrome? 2. Does consumption of thyme increase the quality of life score in patients with irritable bowel syndrome? Researchers will compare thyme supplementation with placebo to see if thyme supplement enhances the effects of a low FODAMP diet on clinical symptoms and quality of life in patients with irritable bowel syndrome. Participants will: 1. Receive thyme supplement plus a low FODMAP diet or placebo with low FODMAP diet for 8 weeks. 2. Recorde 3 days (1weekend and 2 workday) dietary recalls at week 4 and week 8 to assess adherence to the low FODMP diet. 3. Visit the clinic at the beginning of the study and the end of the study for a check-up and score record
Interventions
DIETARY_SUPPLEMENTThyme extract
Three Gastrolit capsules daily with a low FODMAP diet for 8 weeks
OTHERPlacebo
Placebo capsules daily with a low FODMAP diet for 8 weeks
Sponsors
Shahid Beheshti University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Ages 18-65; * Patients with irritable bowel syndrome; * Body Mass Index in the range of 18-25 kg/m2
Exclusion criteria
* Any organic intestinal disease; * Medical history of chronic gastrointestinal and colorectal disease; * Any major bowel surgery; * Medical history of liver and kidney disorders; * Regular use of laxative, anti-diarrhea and anti inflammatory medications.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Irritable Bowel Syndrome symptom severity score | baseline and 8 weeks following therapy | The primary outcome measure will be a change in the Irritable Bowel Symptom Severity Scale (IBS-SS) from baseline to 8 weeks at the conclusion of therapy. The IBS-SS scale ranges from 0 to 500 . Scores of 75-175, 175-300, and 300-500 indicate mild, moderate, and severe cases. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Defecation frequency | baseline and 8 weeks following therapy | The secondary outcome measure will be a change in stool frequency from baseline to 8 weeks at the conclusion of therapy. Stool frequency (number of stools per day) is assessed through an interview |
| Stool consistency | baseline and 8 weeks following therapy | The secondary outcome measure will be a change in stool consistency from baseline to 8 weeks at the conclusion of therapy. Stool consistency is assessed using the validated Bristol Stool Form Scale. |
| Quality of life score | baseline and 8 weeks following therapy | The secondary outcome measure will be a change in quality of life from baseline to 8 weeks at the conclusion of therapy. The quality of life (QoL) is assessed by using a self-report QoL measure specific to IBS (IBS-QoL) with 34 items. Each item has a 5-point Likert scale. Items scores are summed to derive the overall score and transformed to a 0- to 100-scale. The higher scores indicate a better QoL. |
Contacts
Primary ContactSamira Rastgoo
Outcome results
None listed