Curcumin, Vitamin D and Green Tea in IBS-D

Dr Anthony Hobson

Status: Enrolling

Conditions: Irritable Bowel Syndrome With Diarrhea (IBS-D); Irritable Bowel Syndrome (IBS)

Treatments: Dietary Supplement: Placebo Capsule(s); Dietary Supplement: Curcumin, vitamin d and green tea extract

Study type: Interventional

Funder types: Other

Identifiers

NCT07052890

FGC-24-002

Details and patient eligibility

About

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).

Enrollment: 78 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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.
2. Participant has irritable bowel syndrome with diarrhoea (IBS-D), as defined by the Rome IV criteria.
3. Participant has an IBS-SSS score of >175 at screening.
4. Participant is a male or non-pregnant female and is ≥18 years of age
5. Participant can communicate well with the Investigator and to comply with the requirements for the entire study.
6. Participant has capacity to understand written English.
7. Participant has a body mass index (BMI) of 18.5 - 39.9kg/m2 (bounds included).
8. Participant agrees to follow all pre-test preparation before breath testing visits.

Exclusion criteria

1. Prior abdominal surgery other than appendectomy and cholecystectomy.
2. Known hypercalcaemia.
3. Participating in another trial or taken an IMP within the last 1 month.
4. Females who report to be pregnant or lactating
5. Unwilling to maintain stable doses of permitted concomitant medication
6. Unwilling to maintain a stable diet for the duration of the trial
7. Being in the opinion of the investigator unsuitable
8. Insufficient knowledge of English to complete the daily bowel diary and food diary
9. Hypersensitivity to any component of the supplement
10. Hypersensitivity or known allergy to lactulose
11. Drug interactions with any component of the supplement
12. Consumption of antibiotics, prebiotics or probiotics (in food products or as supplements) in the last 4 weeks prior to, or during the study.
13. Vitamin D two week washout
14. Participants who have received bowel preparation for investigative procedures in the 4 weeks prior to the study
15. Individuals declaring additional specific dietary needs
16. Inflammatory bowel disease or coeliac disease
17. Any other condition, deemed by the investigator, that may be causing their symptoms
18. No major co-morbidity.
19. Participant is involved in this study as an Investigator, sub-Investigator, study coordinator, other study staff, or Sponsor member.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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78 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

28 days placebo capsules 4x daily, followed by 28 days of open label active treatment

Treatment:

Dietary Supplement: Placebo Capsule(s)

Curcumin, Vitamin D and Green tea

Experimental group

Description:

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)

Treatment:

Dietary Supplement: Curcumin, vitamin d and green tea extract

Dietary Supplement: Placebo Capsule(s)