DOP68 CD-TREAT diet induces remission and improves quality of life in an open label trial in children and adults with active Crohn’s Disease

Abstract

Background Exclusive enteral nutrition (EEN) is an established induction treatment for active Crohn’s disease (CD) with a proposed mechanism of action involving the gut microbiome. We have previously shown that CD-TREAT diet, a food-based diet with similar dietary profile to EEN, improves rat ileitis and replicates the effect of EEN on the gut microbiome of healthy volunteers and animal models. Here, we test the efficacy of CD-TREAT diet to induce clinical remission in active CD. Methods This is an open-label study in children (wPCDAI≥12.5) and adults (HBI≥5) with active CD. Primary outcome was clinical response (wPCDAI fall≥17.5; HBI fall≥3) or clinical remission (wPCDAI< 12.5; HBI<5) after 8 week treatment with CD-TREAT. Secondary outcomes included improvement of quality of life (QoL) and reduction in faecal calprotectin (FC) levels. Since CD-TREAT diet is gluten-free, adherence to treatment was assessed by the detection of the gluten immunogenic peptide (GIP) in faeces. Data are presented with median (IQR). Results 25 children, [age, 14.4 (12.5,15.7) years] and 32 adults, [age, 32.6 (24.2,43.9) years] were treated. 7 (12%) failed treatment and n=10 (18%) dropped out during the first 2 weeks of treatment due to palatability issues. In patients who completed 8 weeks of CD-TREAT course (n=40), 85% and 78% achieved clinical response and remission, respectively. CD-TREAT diet improved QoL in children [IMPACT-III score, baseline: 136 (122,143) vs 8weeks: 148 (133,153), p<0.01] and in adults [sIBDq score, baseline: 30 (26,45) vs 8weeks: 60 (48, 64), p<0.001]. Faecal GIP decreased during treatment [ng/g stool, baseline: 1250 (589, 1250), 4weeks: 0 (0,269), 8weeks: 0 (0,329), mg/mg, p<0.001 for both] showing adherence with the CD-TREAT diet. However, 33% and 40% of the patients had detectable faecal GIP at 4 and 8 weeks, respectively, revealing at least partial non-adherence. 30% of patients who completed CD-TREAT (n=12/40) experienced >50% FC reduction. Median FC levels decreased significantly? in the group of patients (n=22) who had undetectable GIP at 4 or 8 weeks [mg/kg FC, baseline: 1190 (361,1129); 8weeks: 534 (92,1230), p<0.01]. Conclusion CD-TREAT diet improved disease activity indices and QoL in the majority of patients who completed treatment and decreased FC in those who were most likely to be compliant. Future RCT should aim to compare CD-TREAT with other induction treatments and improve meal variety and palatability to improve compliance and reduce drop-out rates.

British Dietetic Association consensus guidelines on the nutritional assessment and dietary management of patients with inflammatory bowel disease

“…Ten whole food dietary exclusion interventions to induce remission in adults with active IBD were reviewed. These are anti‐inflammatory IBD diet, low FODMAP (i.e., fermentable oligosaccharides, disaccharides, monosaccharides and polyols) diet, Crohn's disease exclusion diet (CDED), IgG4, Western diet, low microparticle diet, semi‐vegetarian plant‐based diet, Mediterranean diet, specific carbohydrate diet (SCD) and Crohn's disease TReatment with EATing diet (CD‐TREAT) 109–112 . The results of a feasibility study of a low emulsifier diet in adults with active IBD are also promising 113 .…”

“…An open‐label trial in 32 adults with mild‐to‐moderately active Crohn's disease has been conducted. The trial showed that 23 of 32 adults completed the 8‐week treatment and patients who strictly adhered to the treatment had a significant reduction in faecal calprotectin and 80% achieved clinical disease remission 110 …”

“…The trial showed that 23 of 32 adults completed the 8-week treatment and patients who strictly adhered to the treatment had a significant reduction in faecal calprotectin and 80% achieved clinical disease remission. 110 Low FODMAP diet 119 The low FODMAP diet is a phased dietary approach that initially restricts the intake of short-chain fermentable carbohydrates. One RCT compared the low FODMAP diet to a normal diet in patients with mildmoderately active IBD (n = 13) or IBD in remission (n = 65) with co-existing functional bowel symptoms.…”

Ultra-processed foods as a possible culprit for the rising prevalence of inflammatory bowel diseases

“…In this diet, emulsifying agents, processed meats, and animal fat are excluded and protein, vitamins, minerals and fiber content are increased ( 94 ). These dietary changes are able to establish the same microbial alterations as EEN, decrease gut inflammation, and induce clinical remission in patients with active CD ( 98 , 99 ).…”

Holistic healthcare in inflammatory bowel disease: time for patient-centric approaches?

“…In a small pilot study in children with CD and healthy volunteers, promising results were obtained regarding clinical and endoscopic remission, as well as beneficial changes to the stool microbiota and metabolome 67. An 8-week open-label follow-up study in 25 children and 32 adults with active CD as an induction treatment showed improved disease activity indices and QoL in the majority of patients who completed treatment and decreased FC in those who were most likely to be compliant 68. However, only 40 patients completed the study and no endoscopic endpoints were considered.…”