Role of a Food Supplement Containing Curcumin, Green Tea and Vitamin D on Symptom Control in Diarrhoea Predominant Irritable Bowel Syndrome (IBS-D)

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
United Kingdom
The Functional Gut Clinic Cambridge
RECRUITING
Cambridge
The Functional Gut Clinic London
RECRUITING
London
The Functional Gut Clinic Manchester
RECRUITING
Manchester
Contact Information
Primary
Jessica Bailey
jessica.bailey@thefunctionalgutclinic.com
+441613027777
Time Frame
Start Date: 2024-09-19
Estimated Completion Date: 2025-09
Participants
Target number of participants: 78
Treatments
Placebo_comparator: Placebo
28 days placebo capsules 4x daily, followed by 28 days of open label active treatment
Experimental: Curcumin, Vitamin D and Green tea
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)
Sponsors
Leads: Dr Anthony Hobson

This content was sourced from clinicaltrials.gov