Curcumin, Vitamin D and Green Tea in IBS-D

Last updated: July 1, 2025
Sponsor: Dr Anthony Hobson
Overall Status: Active - Recruiting

Phase

N/A

Condition

Irritable Bowel Syndrome (Ibs)

Bowel Dysfunction

Lactose Intolerance

Treatment

Curcumin, vitamin d and green tea extract

Placebo Capsule(s)

Clinical Study ID

NCT07052890
FGC-24-002
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Participant has provided written informed consent before participating in the studyafter being given a full description of the study and prior to any study-specificprocedures being performed.

  2. Participant has irritable bowel syndrome with diarrhoea (IBS-D), as defined by theRome 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 therequirements 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

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 assupplements) 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, studycoordinator, other study staff, or Sponsor member.

Study Design

Total Participants: 78
Treatment Group(s): 2
Primary Treatment: Curcumin, vitamin d and green tea extract
Phase:
Study Start date:
September 19, 2024
Estimated Completion Date:
September 30, 2025

Connect with a study center

  • The Functional Gut Clinic Cambridge

    Cambridge, CB2 1LR
    United Kingdom

    Active - Recruiting

  • The Functional Gut Clinic London

    London, NW1 6PU
    United Kingdom

    Active - Recruiting

  • The Functional Gut Clinic Manchester

    Manchester, m3 4bg
    United Kingdom

    Active - Recruiting

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