Effectiveness of Thyme in the Management of Clinical Symptoms in Patients with Irritable Bowel Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Thyme extract, Placebo.
- Who it may be relevant to
- Registry conditions: Irritable Bowel Syndrome (IBS). Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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 supplement Thyme extract
Three Gastrolit capsules daily with a low FODMAP diet for 8 weeks - Other Placebo
Placebo capsules daily with a low FODMAP diet for 8 weeks
Primary outcome measures
- Irritable Bowel Syndrome symptom severity score [Time frame: baseline and 8 weeks following therapy]
Secondary outcome measures (3)
- Defecation frequency [Time frame: baseline and 8 weeks following therapy]
- Stool consistency [Time frame: baseline and 8 weeks following therapy]
- Quality of life score [Time frame: baseline and 8 weeks following therapy]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Supportive care
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06609746 · IR.SBMU.RETECH.REC.1399.1034