Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Irritable Bowel Syndrome (IBS) is a highly prevalent condition of the gastrointestinal tract that has significant impact on sufferer's quality of life. The diarrhoea variant (IBS-D) makes up around one third of all IBS sufferers. There is currently a lack of both effective pharmacological and non-pharmacological treatments for IBS-D.
Three food supplements: Green tea, vitamin D and curcumin have all been shown to demonstrate benefit in either reducing symptoms in IBS or diarrhoea as individual ingredients, but have never been tested in combination to assess their effectiveness in IBS. This research study aims to examine the effectiveness of green tea, vitamin D and curcumin in combination compared to a placebo capsule in individual suffering from IBS-D.
The study will aim to enroll 78 participants with IBS-D and utilise a placebo-controlled double blind design. The study will consist of a 2 week screening period, a 4 week randomised treatment period (50% participants to receive placebo, 50% to receive active treatment), followed by a 4 week open label treatment period (all participants to receive the active study product).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 28 days placebo capsules 4x daily, followed by 28 days of open label active treatment |
|
| Curcumin, Vitamin D and Green tea | Experimental | 28 days Curcumin, Vitamin D and Green tea capsules 4x daily, followed by a further 28 days of this treatment but non-blinded (open label) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Curcumin, vitamin d and green tea extract | Dietary Supplement | A combination of the following ingrediants per 4 capsules: CurcuWin® 1000mg - of which 200mg Curcuminoids Green Tea Extract 400mg - (0.1-0.5% caffeine) Vitamin D₃ 50 µg 2000IU |
| Measure | Description | Time Frame |
|---|---|---|
| Mean decrease of Irritable bowel syndrome symptom severity score (IBS-SSS) | Mean change in IBS-SSS at the end of the randomised treatment phase between Active and placebo arms. The IBS-SSS is numeric score based on 5 questions (each rated 0-100), with a total minimum score of 0 and maximum of 500, with a higher score indicating greater severity of symptoms. | From Enrollment to end of 4 week randomised treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Use of rescue medication | Average change in rescue medication use from week 1 of randomisation period compared to week 4 of randomisation period, between active and placebo arms | 4 weeks |
| Assessment of change breath methane levels during hydrogen and methane breath testing (HMBT) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Anthony Hobson, PhD | The Functional Gut Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Functional Gut Clinic Cambridge | Cambridge | CB2 1LR | United Kingdom | |||
| The Functional Gut Clinic London |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D003474 | Curcumin |
| D014807 | Vitamin D |
| D013662 | Tea |
| ID | Term |
|---|---|
| D036381 | Diarylheptanoids |
| D006536 | Heptanes |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
Not provided
Not provided
The study will utilise a double blind design with 1:1 active to placebo, with crossover to open label treatment. The study comprises of a 2 week screening period followed by a 4 week randomised treatment period. At the end of the randomisation treatment period, participants will all receive active treatment open label for a further 4 weeks.
Not provided
Not provided
Not provided
| Placebo Capsule(s) | Dietary Supplement | Placebo - identical capsules containing inert color matched power |
|
Assessment of effect of active treatment vs placebo on breath hydrogen levels from baseline to end of randomised treatment period. Breath hydrogen levels will be measured using a lactulose hydrogen and methane breath test. Total area under the curve for methane during the test will be calculated. |
| 4 weeks |
| Mean change irritable bowel syndrome quality of life (IBS-QoL) questionnaire score | Mean change IBS-QoL scores from baseline to end of randomised treatment period, between active and placebo groups. The IBS-QoL questionnaire is made up of 34 questions each scored 1-5. Higher scores indicate better quality of life. Lower scores suggest more severe impact of IBS on daily living. | 4 weeks |
| Longevity of treatment effect | Longevity of treatment effect assessed in the active group with comparison of IBS-SSS scores from the randomised treatment period to end of open label period. The IBS-SSS is numeric score based on 5 questions (each rated 0-100), with a total minimum score of 0 and maximum of 500, with a higher score indicating greater severity of symptoms. | 8 weeks |
| Stool Consistency | Stool Consistency assessed as average number of days with Bristol Stool Scale type (mean over 4 weeks, mean of first week and last week of the randomisation period). A favorable change in mean score would be changes from type 6 or 7 stools (diarrhoea type stool consistency) to type 3,4,5 stools, which are considered normal stool consistency. | 4 weeks |
| Stool frequency | Stool Frequency (mean of 4 weeks, mean of first week and last week of the randomisation period) | 4 weeks |
| Change in bloating measured using daily bowel diary. | Change in average daily bloating score for week 1 of the randomised treatment period to week 4 of the randomised treatment period. Severity of bloating will be scored daily by participants on a scale of 0-3, 0 being no bloating, 3 being severe bloating. | 4 weeks |
| Change in abdominal pain measured using the daily bowel diary | Change in average daily abdominal pain score for week 1 of the randomised treatment period to week 4 of the randomised treatment period. Severity of abdominal pain will be scored daily by participants on a scale of 0-3, 0 being no bloating, 3 being severe bloating. | 4 weeks |
| Breath Hydrogen levels measured using hydrogen and methane breath testing (HMBT) | Assessment of effect of active treatment vs placebo on breath hydrogen levels from baseline to end of randomised treatment period. Breath hydrogen levels will be measured using a lactulose hydrogen and methane breath test. Total area under the curve for hydrogen during the test will be calculated. | 4 weeks |
| London |
| NW1 6PU |
| United Kingdom |
| The Functional Gut Clinic Manchester | Manchester | m3 4bg | United Kingdom |
| D004066 | Digestive System Diseases |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |