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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thyme | Experimental | Taking thyme extract capsules with a low FODMAP diet |
|
| placebo | Placebo Comparator | Taking placebo capsules with a low FODMAP diet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thyme extract | Dietary Supplement | Three Gastrolit capsules daily with a low FODMAP diet for 8 weeks |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Samira Rastgoo | Contact | 00989171430391 | samiraa.rastgoo@gmail.com |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| C000713847 | thyme extract |
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| Placebo | Other | Placebo capsules daily with a low FODMAP diet for 8 weeks |
|
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 |
| D004066 | Digestive System Diseases |