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

NCT06609746 | Not Yet Recruiting

• 1 other identifier: IR.SBMU.RETECH.REC.1399.1034
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

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. 1.Does consumption of thyme reduce the severity score of clinical symptoms in patients with irritable bowel syndrome?
2. 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.
3. 3.Receive thyme supplement plus a low FODMAP diet or placebo with low FODMAP diet for 8 weeks.
4. 4.Recorde 3 days (1weekend and 2 workday) dietary recalls at week 4 and week 8 to assess adherence to the low FODMP diet.
5. 5.Visit the clinic at the beginning of the study and the end of the study for a check-up and score record

Conditions

Irritable Bowel Syndrome (IBS)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

Thyme

EXPERIMENTAL

Taking thyme extract capsules with a low FODMAP diet

Dietary Supplement: Thyme extract

placebo

PLACEBO COMPARATOR

Taking placebo capsules with a low FODMAP diet

Other: Placebo

Interventions

Thyme extract DIETARY_SUPPLEMENT

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

Also known as: Gastrolit

Thyme

Placebo OTHER

Placebo capsules daily with a low FODMAP diet for 8 weeks

placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages 18-65;
• Patients with irritable bowel syndrome;
• Body Mass Index in the range of 18-25 kg/m2

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shahid Beheshti University of Medical Sciences: lead

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

thyme extract

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Central Study Contacts

Samira Rastgoo

CONTACT

00989171430391; samiraa.rastgoo@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 14, 2024
• First Posted: September 24, 2024
• Study Start: October 21, 2024
• Primary Completion: March 1, 2025
• Study Completion: April 1, 2025
• Last Updated: September 24, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR