Effectiveness of Thyme in the Management of Clinical Symptoms in Patients with Irritable Bowel Syndrome

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Irritable Bowel Syndrome (IBS)
• Intervention / Treatment: Dietary supplement: Thyme extract; Other: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Samira Rastgoo; Phone Number: 00989171430391; Email: samiraa.rastgoo@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Thyme; Taking thyme extract capsules with a low FODMAP diet	Dietary supplement: Thyme extract; Three Gastrolit capsules daily with a low FODMAP diet for 8 weeks; Other Names: Gastrolit
Placebo Comparator: placebo; Taking placebo capsules with a low FODMAP diet	Other: Placebo; Placebo capsules daily with a low FODMAP diet for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Irritable Bowel Syndrome symptom severity score	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.	baseline and 8 weeks following therapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Defecation frequency	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	baseline and 8 weeks following therapy
Stool consistency	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.	baseline and 8 weeks following therapy
Quality of life score	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.	baseline and 8 weeks following therapy

Collaborators and Investigators

• Sponsor: Shahid Beheshti University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): October 21, 2024
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: September 14, 2024
• First Submitted That Met QC Criteria: September 21, 2024
• First Posted (Actual): September 24, 2024

Study Record Updates

• Last Update Posted (Actual): September 24, 2024
• Last Update Submitted That Met QC Criteria: September 21, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome
• Other Study ID Numbers: IR.SBMU.RETECH.REC.1399.1034

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No