Curcumin, Vitamin D and Green Tea in IBS-D (NCT07052890) | Clinical Trial Compass
CompletedNot Applicable
Curcumin, Vitamin D and Green Tea in IBS-D
United Kingdom78 participantsStarted 2024-09-19
Plain-language summary
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).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Participant has provided written informed consent before participating in the study after being given a full description of the study and prior to any study-specific procedures being performed.
✓. Participant has irritable bowel syndrome with diarrhoea (IBS-D), as defined by the Rome IV criteria.
✓. Participant has an IBS-SSS score of \>175 at screening.
✓. Participant is a male or non-pregnant female and is ≥18 years of age
✓. Participant can communicate well with the Investigator and to comply with the requirements for the entire study.
✓. Participant has capacity to understand written English.
✓. Participant has a body mass index (BMI) of 18.5 - 39.9kg/m2 (bounds included).
✓. Participant agrees to follow all pre-test preparation before breath testing visits.
Exclusion criteria
✕. Prior abdominal surgery other than appendectomy and cholecystectomy.
What they're measuring
1
Mean decrease of Irritable bowel syndrome symptom severity score (IBS-SSS)
Timeframe: From Enrollment to end of 4 week randomised treatment period