Curcumin, Vitamin D and Green Tea in IBS-D

NCT07052890 | Completed

• 1 other identifier: FGC-24-002
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 3

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)

Outcome Measures

Primary Outcomes (1)

• Mean decrease of Irritable bowel syndrome symptom severity score (IBS-SSS)

  Mean change in IBS-SSS at the end of the randomised treatment phase between Active and placebo arms. The IBS-SSS is numeric score based on 5 questions (each rated 0-100), with a total minimum score of 0 and maximum of 500, with a higher score indicating greater severity of symptoms.

  From Enrollment to end of 4 week randomised treatment period

Secondary Outcomes (9)

• Use of rescue medication

  4 weeks

• Assessment of change breath methane levels during hydrogen and methane breath testing (HMBT)

  4 weeks

• Mean change irritable bowel syndrome quality of life (IBS-QoL) questionnaire score

  4 weeks

• Longevity of treatment effect

  8 weeks

• Stool Consistency

  4 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo Capsule(s)

Curcumin, Vitamin D and Green tea

EXPERIMENTAL

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)

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

Interventions

Placebo Capsule(s) DIETARY_SUPPLEMENT

Placebo - identical capsules containing inert color matched power

Curcumin, Vitamin D and Green tea; Placebo

Curcumin, vitamin d and green tea extract 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

Curcumin, Vitamin D and Green tea

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Prior abdominal surgery other than appendectomy and cholecystectomy.
• Known hypercalcaemia.
• Participating in another trial or taken an IMP within the last 1 month.
• Females who report to be pregnant or lactating
• Unwilling to maintain stable doses of permitted concomitant medication
• Unwilling to maintain a stable diet for the duration of the trial
• Being in the opinion of the investigator unsuitable
• Insufficient knowledge of English to complete the daily bowel diary and food diary
• Hypersensitivity to any component of the supplement
• Hypersensitivity or known allergy to lactulose
• Drug interactions with any component of the supplement
• Consumption of antibiotics, prebiotics or probiotics (in food products or as supplements) in the last 4 weeks prior to, or during the study.
• Vitamin D two week washout
• Participants who have received bowel preparation for investigative procedures in the 4 weeks prior to the study
• Individuals declaring additional specific dietary needs

Sponsors & Collaborators

• Dr Anthony Hobson: lead

Study Sites (3)

The Functional Gut Clinic Cambridge

Cambridge, CB2 1LR, United Kingdom

Location

The Functional Gut Clinic London

London, NW1 6PU, United Kingdom

Location

The Functional Gut Clinic Manchester

Manchester, m3 4bg, United Kingdom

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Curcumin; Vitamin D; Tea

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Anthony Hobson, PhD

  The Functional Gut Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant Clinical Scientist

Model Details: The study will utilise a double blind design with 1:1 active to placebo, with crossover to open label treatment. The study comprises of a 2 week screening period followed by a 4 week randomised treatment period. At the end of the randomisation treatment period, participants will all receive active treatment open label for a further 4 weeks.

Study Record Dates

• First Submitted: June 10, 2025
• First Posted: July 8, 2025
• Study Start: September 19, 2024
• Primary Completion: December 8, 2025
• Study Completion: January 30, 2026
• Last Updated: March 11, 2026

Record last verified: 2026-03

Locations

GB (3)