{
  "abstract": "Introduction Irritable bowel syndrome with diarrhoea (IBS-D) causes substantial symptoms and has limited effective treatment options. Vitamin D and curcumin each have evidence supporting improvements in IBS symptoms, while green tea polyphenols exhibit anti-inflammatory activity beneficial to intestinal epithelial function. We conducted a randomised, double-blind, placebo-controlled trial with an open-label extension to assess the effect of a supplement containing curcumin, green tea polyphenols and vitamin D (HG01) on symptom severity in IBS-D (ClinicalTrials.gov NCT07052890).Methods Seventy-eight adults (53 female:25 male, age 21–75) meeting Rome IV IBS-D criteria with moderate–severe disease (IBS-SSS > 175) were randomised 1:1 to active treatment or placebo for 4 weeks, followed by 4 weeks of open-label active treatment. Participants and investigators remained blinded during the randomised phase. Change in IBS-SSS from baseline to the end of randomisation was analysed using a baseline-adjusted mixed-effects repeated-measures model including participants with evaluable endpoint data. Fifty-one participants (27 active, 24 placebo) contributed to the primary endpoint analysis. Non-evaluable cases (n=27, 12 from active and 15 from placebo groups) were due to withdrawal (7), loss to follow-up (12), initiation of prohibited medication (2), or missing endpoint data (6). The same model assessed within-group change from the end of randomisation to the end of open-label treatment.Results The adjusted between-group difference in IBS-SSS change at the end of randomisation was −55.14 points (95% CI −108.12 to −2.14; p=0.042), consistent with a clinically meaningful improvement. Estimated marginal mean change was −54.84 (95% CI −90.15 to −19.52) with active treatment compared with +0.30 (95% CI −37.77 to 38.37) with placebo. During the open-label phase, participants initially receiving placebo demonstrated significant improvement after switching to active treatment (−62.57; 95% CI −92.45 to −32.70; p<0.001), while those receiving active treatment throughout showed no significant further change (+11.74; 95% CI −16.13 to 39.62; p=0.405). The intervention was well tolerated; all reported adverse events were mild and no serious adverse events occurred.Conclusions The supplement HG01 significantly reduced IBS-SSS compared with placebo, demonstrating clinically meaningful symptom improvement in IBS-D.",
  "authors": [
    {
      "affiliations": [
        "The Functional Gut Clinic, Manchester, United Kingdom"
      ],
      "name": "Sam Treadway"
    },
    {
      "affiliations": [
        "The Functional Gut Clinic, Manchester, United Kingdom"
      ],
      "name": "Jessica Bailey"
    },
    {
      "affiliations": [
        "Altruvita, London, United Kingdom"
      ],
      "name": "Tara Whyand"
    },
    {
      "affiliations": [
        "Altruvita, London, United Kingdom"
      ],
      "name": "Katie Murray"
    },
    {
      "affiliations": [
        "Select Statistics, United Kingdom"
      ],
      "name": "Jo Morrison"
    },
    {
      "affiliations": [
        "The Functional Gut Clinic, Manchester, United Kingdom"
      ],
      "name": "Anthony Hobson"
    },
    {
      "affiliations": [
        "Altruvita, London, United Kingdom",
        "Royal Free Hospital, London, United Kingdom"
      ],
      "name": "Martyn Caplin"
    }
  ],
  "title": "O82 Efficacy of a combination curcumin/green tea/vitamin D supplement on symptom severity in IBS D: a randomised, double-blind placebo controlled trial",
  "uid": "6e9bff21-317b-5a0c-ba84-3806b2177b6c"
}