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NCT Number: NCT06609746

Effectiveness of Thyme in the Management of Clinical Symptoms 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

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Key information

Conditions

Irritable Bowel Syndrome (IBS) Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Irritable Bowel Syndrome

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Thyme extract

Dietary Supplement

Three Gastrolit capsules daily with a low FODMAP diet for 8 weeks

Other names: Gastrolit

Placebo

Other

Placebo capsules daily with a low FODMAP diet for 8 weeks

Primary outcomes

  1. 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

  1. Defecation frequency

    Time frame: 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

  2. Stool consistency

    Time frame: 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.

  3. Quality of life score

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Samira Rastgoo

CONTACT

[email protected]

00989171430391

Sponsors and collaborators

Lead sponsor

Shahid Beheshti University of Medical Sciences

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 24, 2024
Registry last updated
Sep 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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