NCT06609746Not yet recruitingNot Applicable
The Effect of Low FODMAP (Fermentable, Oligo-, Di-, Mono-saccharides and Polyols) Diet with Thyme on Clinical Symptoms and Quality of Life in Patients with Irritable Bowel Syndrome
Shahid Beheshti University of Medical Sciences0 sites52 target enrollmentStarted: October 21, 2024Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 52
- Primary Endpoint
- Irritable Bowel Syndrome symptom severity score
Study Overview
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:
- Does consumption of thyme reduce the severity score of clinical symptoms in patients with irritable bowel syndrome?
- 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:
- Receive thyme supplement plus a low FODMAP diet or placebo with low FODMAP diet for 8 weeks.
- Recorde 3 days (1weekend and 2 workday) dietary recalls at week 4 and week 8 to assess adherence to the low FODMP diet.
- Visit the clinic at the beginning of the study and the end of the study for a check-up and score record
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
Irritable Bowel Syndrome symptom severity score
Time Frame: 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 Outcomes
- Defecation frequency(baseline and 8 weeks following therapy)
- Stool consistency(baseline and 8 weeks following therapy)
- Quality of life score(baseline and 8 weeks following therapy)
Investigators
Samira Rastgoo
Principal Investigator
Shahid Beheshti University of Medical Sciences
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