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

NCT ID: NCT06609746

Last Updated: 2024-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-21

Study Completion Date

2025-04-30

Brief Summary

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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

Detailed Description

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Conditions

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Irritable Bowel Syndrome (IBS)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Thyme

Taking thyme extract capsules with a low FODMAP diet

Group Type EXPERIMENTAL

Thyme extract

Intervention Type DIETARY_SUPPLEMENT

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

placebo

Taking placebo capsules with a low FODMAP diet

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo capsules daily with a low FODMAP diet for 8 weeks

Interventions

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Thyme extract

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo capsules daily with a low FODMAP diet for 8 weeks

Intervention Type OTHER

Other Intervention Names

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Gastrolit

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Samira Rastgoo

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Samira Rastgoo

Role: CONTACT

00989171430391

Other Identifiers

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IR.SBMU.RETECH.REC.1399.1034

Identifier Type: -

Identifier Source: org_study_id

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