Curcumin, Vitamin D and Green Tea in IBS-D

NCT ID: NCT07052890

Last Updated: 2025-11-28

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-19
• Study Completion Date: 2025-12-31

Brief 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).

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo Capsule(s)

Intervention Type: DIETARY_SUPPLEMENT

Placebo - identical capsules containing inert color matched power

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)

Group Type: EXPERIMENTAL

Curcumin, vitamin d and green tea extract

Intervention Type: 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

Placebo Capsule(s)

Intervention Type: DIETARY_SUPPLEMENT

Placebo - identical capsules containing inert color matched power

Interventions

Curcumin, vitamin d and green tea extract

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo Capsule(s)

Placebo - identical capsules containing inert color matched power

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dr Anthony Hobson

OTHER

Sponsor Role: lead

Responsible Party

Dr Anthony Hobson

Consultant Clinical Scientist

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Anthony Hobson, PhD

Role: PRINCIPAL_INVESTIGATOR

The Functional Gut Clinic

Locations

The Functional Gut Clinic Cambridge

Cambridge, , United Kingdom

The Functional Gut Clinic London

London, , United Kingdom

The Functional Gut Clinic Manchester

Manchester, , United Kingdom

Countries

United Kingdom

Other Identifiers

FGC-24-002

Identifier Type: -

Identifier Source: org_study_id