Irritable Bowel Syndrome (IBS)NCT06609746
Effectiveness of Thyme in the Management of Clinical Symptoms in Patients with Irritable Bowel Syndrome
A study testing Thyme extract in people with Irritable Bowel Syndrome (IBS), run by Shahid Beheshti University of Medical Sciences.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Irritable Bowel Syndrome (IBS)
- What is being tested?
- Thyme extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 21 Oct 2024to Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 18-65;
- Patients with irritable bowel syndrome;
- Body Mass Index in the range of 18-25 kg/m2
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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
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:
Read more
- Does consumption of thyme reduce the severity score of clinical symptoms in patients with irritable bowel syndrome?
- 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:
- Receive thyme supplement plus a low FODMAP diet or placebo with low FODMAP diet for 8 weeks.
- Recorde 3 days (1weekend and 2 workday) dietary recalls at week 4 and week 8 to assess adherence to the low FODMP diet.
- 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)
- Being tested
- Thyme extract, Placebo
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thyme extractDietary supplement
Also called Gastrolit
Three Gastrolit capsules daily with a low FODMAP diet for 8 weeks
PlaceboOther
Placebo capsules daily with a low FODMAP diet for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Thyme | Experimental | Taking thyme extract capsules with a low FODMAP diet Receives: Dietary Supplement: Thyme extract |
| placebo | Placebo comparator | Taking placebo capsules with a low FODMAP diet Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and 8 weeks following therapy
Secondary outcomes (3)
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
Measured: 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.
Measured: 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.
Measured: baseline and 8 weeks following therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start21 Oct 2024 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel Syndrome (IBS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samira Rastgoo, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06609746
- Sponsor's protocol ID
- IR.SBMU.RETECH.REC.1399.1034
- Status last verified
- Sep 2024
- First submitted
- 14 Sep 2024
- Last updated
- 24 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06609746
- Acronym / sponsor ID
- IR.SBMU.RETECH.REC.1399.1034
- Conditions
- Irritable Bowel Syndrome (IBS)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- 21 Oct 2024 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 24 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does consumption of thyme reduce the severity score of clinical symptoms in patients with irritable bowel syndrome?
- 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:
- Receive thyme supplement plus a low FODMAP diet or placebo with low FODMAP diet for 8 weeks.
- Recorde 3 days (1weekend and 2 workday) dietary recalls at week 4 and week 8 to assess adherence to the low FODMP diet.
- Visit the clinic at the beginning of the study and the end of the study for a check-up and score record
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thyme | Experimental | Dietary Supplement: Thyme extractTaking thyme extract capsules with a low FODMAP diet |
| placebo | Placebo comparator | Other: PlaceboTaking placebo capsules with a low FODMAP diet |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ages 18-65;
- Patients with irritable bowel syndrome;
- Body Mass Index in the range of 18-25 kg/m2
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thyme extractAlso: GastrolitThree Gastrolit capsules daily with a low FODMAP diet for 8 weeks | Dietary supplement | Thyme |
| PlaceboPlacebo capsules daily with a low FODMAP diet for 8 weeks | Other | placebo |
Primary outcome
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.
3 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Thyme extract in people with Irritable Bowel Syndrome (IBS), run by Shahid Beheshti University of Medical Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samira Rastgoo (00989171430391, samiraa.rastgoo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Irritable Bowel Syndrome symptom severity score (time frame: baseline and 8 weeks following therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2024.