Crohn's disease (CD) is a chronic, incurable condition associated with inflammation in the gut lining. It causes diarrhoea, severe abdominal pain, poor nutrition and adversely affects the quality of life of sufferers. Two of the best treatments currently used in people with CD are drug injections and/or infusions (biologics), and a liquid-only diet using specialised milkshakes. However, treatment with biologics is only successful in approximately 40% of the patients, and although treatment with the liquid-only diet has a better safety and effectiveness profile, it is difficult for patients to stick to this as their sole source of nutrition for 6-8 weeks, particularly for adults. BIOPIC study aims to investigate whether replacing half of a habitual diet with specialised milkshakes will improve response to standard treatment with biologics in adults with CD.
80 adult patients with active CD who are due to start biologic injections therapy with adalimumab as part of their standard of care for the first time will be recruited for this study. Patients will be randomly allocated to replace either half of their normal diet with nutritionally complete milkshakes or to follow their usual diet for 6 weeks. The investigators will compare the proportion of patients whose symptoms and disease markers will improve between the two groups at 6 and 12 weeks, and how many of them will remain symptoms-free for up to a year following treatment. The investigators will also explore whether the half-liquid diet will influence patients' nutrition and quality of life. Last, the investigators will investigate if gut bacteria changes and their metabolites associate with patients' eating habits and their responses to treatment with biologics. The primary aim of the BIOPIC study is to investigate if replacement of 50% of habitual food intake with a proprietary liquid diet for 6 weeks will improve remission rates at 12 weeks in adult patients with active ileocolonic CD treated with first-line biologics (TNFα antagonists, adalimumab) as their standard treatment of care. The secondary aim is to investigate if replacement of 50% of habitual food intake with a proprietary liquid diet for 6 weeks will prolong remission in adult patients with active ileocolonic CD treated with first-line biologics (TNFα antagonists) as their standard treatment of care.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Dietary intervention (Liquid food replacement intervention)
Glasgow Royal Infirmary
Glasgow, Scotland, United Kingdom
RECRUITINGQueen Elizabeth University Hospital
Glasgow, Scotland, United Kingdom
RECRUITINGGartnavel General Hospital
Glasgow, United Kingdom
RECRUITINGThe New Victoria Hospital
Glasgow, United Kingdom
RECRUITINGCrohn's Disease Activity Index
Comparison of Crohn's Disease Activity Index (CDAI) score (approximate range: 0-600) between the intervention (PEN) and control group (unrestricted diet). Higher CDAI scores indicate worse outcomes. Clinical response is defined as baseline CDAI score decrease of ≥ 70, and clinical remission is defined as CDAI score \<150.
Time frame: Baseline to 52 weeks
Harvey-Bradshaw Index
Comparison of Harvey-Bradshaw Index (HBI) score (approximate range: 0-50) between the intervention (PEN) and control group (unrestricted diet). Higher HBI scores indicate worse outcomes. Clinical response is defined as baseline HBI score decrease of ≥ 3, and clinical remission is defined as score \<5\]
Time frame: Baseline to 52 weeks
Faecal Calprotectin
Comparison of faecal calprotectin levels between the two groups. Higher scores indicate worse outcomes.
Time frame: Baseline to 12 weeks
Blood C-Reactive Protein
Comparison of blood C-reactive protein levels between the two groups. Abnormal values indicate worse outcomes.
Time frame: Baseline to 12 weeks
Blood Erythrocyte Sedimentation Rate
Comparison of blood erythrocyte sedimentation rates between the two groups. Abnormal values indicate worse outcomes.
Time frame: Baseline to 12 weeks
Blood Albumin
Comparison of blood albumin levels between the two groups. Abnormal values indicate worse outcomes.
Time frame: Baseline to 12 weeks
Blood Haemoglobin
Comparison of blood haemoglobin levels between the two groups. Abnormal values indicate worse outcomes.
Time frame: Baseline to 12 weeks
Steroid-free remission
Comparison of steroid-free remission rates between the two groups.
Time frame: Baseline to 52 weeks
Dosage of biologics
Comparison of biologics dose prescribed between the two groups.
Time frame: Baseline to 52 weeks
Blood anti-drug antibodies
Comparison of blood anti-drug antibodies between the two groups.
Time frame: Baseline to 12 weeks
Blood adalimumab
Comparison of blood levels of adalimumab (drug) between the two groups.
Time frame: Baseline to 12 weeks
Micronutrient status
Comparison of micronutrient status measured by NHS laboratories as standard care of treatment between the two groups. Abnormal values indicate worse outcomes.
Time frame: Baseline to 12 weeks
Blood immunophenotype
Comparison of immunophenotype profiles (characterisation of immune cells) measured with flow cytometry immunophenotyping between the two groups. Higher levels of specific pro-inflammatory cells indicate worse outcomes.
Time frame: Baseline to 12 weeks
Self-Administered Inflammatory Bowel Disease Questionnaire
Comparison of Self-Administered Inflammatory Bowel Disease Questionnaire (SIBDQ) scores (range: 10-70) between the two groups. Higher SIBDQ scores indicate better outcomes.
Time frame: Baseline to 12 weeks
Body Mass Index
Comparison of Body Mass Index (BMI) (kg/m2) between the two groups.
Time frame: Baseline to 12 weeks
Body weight
Comparison of body weight (kg) between the two groups.
Time frame: Baseline to 12 weeks
Body fat mass
Comparison of body fat mass (percent, %) measured with Bioelectrical Impedance Analysis between the two groups.
Time frame: Baseline to 12 weeks
Body fat-free mass
Comparison of body fat-free mass (percent, %) measured with Bioelectrical Impedance Analysis between the two groups.
Time frame: Baseline to 12 weeks
Handgrip strength
Comparison of handgrip strength measured with handgrip strength dynamometer between the two groups.
Time frame: Baseline to 12 weeks
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