Background and aims Treatment adherence is key to the efficacy of exclusive enteral nutrition (100% EN) in active Crohn’s disease (CD), but there are no biomarkers to objectively estimate this. We explored faecal parameters as biomarkers of compliance with 100% EN, and subsequently developed and validated the Glasgow Exclusive Enteral Nutrition Index of Compliance (GENIE). Methods Healthy adults replaced all (100% EN) or part (85% EN, 50% EN, 25% EN) of their diet with a formula for 7 days. Faecal pH, water content, short chain fatty acids and branched chain fatty acids (BCFAs) were measured before (D0) and after (D7) each intervention. Optimal biomarkers and threshold values were derived using receiver operating characteristic curve analyses and machine learning to develop the GENIE. The GENIE was then validated in 30 CD children, during and after 100% EN. Results Sixty-one adults were recruited. D7 faecal pH and the ratios of BCFAs to either acetate or butyrate performed the best to differentiate between patients on 100% EN from <100% EN. Two models were generated; one including faecal metabolites (Laboratory GENIE, L-GENIE; sensitivity, specificity, and positive predictive value (PPV) of 88%, 94%, and 92%) and a second one (Clinical Genie, C-GENIE) which considers only faecal pH (sensitivity, specificity and PPV of 84%, 86% and 81%). Validation of GENIE in CD children found that C-GENIE outperformed L-GENIE, producing a sensitivity, specificity and PPV of 85%, 88% and 88%, respectively. Conclusions GENIE can help predict adherence to 100% EN and may complement current conventional dietary assessment.
Background Treatment adherence is key to the efficacy of exclusive enteral nutrition (100% EN) in active Crohn’s disease (CD), but there are currently no biomarkers to objectively support this. We explored faecal parameters as putative biomarkers of compliance with 100% EN, and subsequently developed and validated the Glasgow Exclusive enteral Nutrition Index of compliancE (GENIE). Methods Healthy adults replaced all (100% EN) or part (85% EN, 50% EN and 25% EN) of their habitual diet with a polymeric formula (Modulen IBD, Nestle©) for 7 days. Faecal pH, Bristol stool chart score, water content, short chain fatty acids (SCFAs) and branched chain fatty acids (BCFAs) were measured before (D0) and after (D7) each intervention. Faecal biomarkers and threshold values for group assignments were derived using receiver operating characteristic (ROC) curve analyses and machine learning algorithm to develop the GENIE. The GENIE was validated in 30 children with CD, during 100% EN and 4 weeks after return to normal diet. Results Sixty-one (31 females) adults (mean age [SD]: 25.9 [4.3] years) were recruited. D7 faecal pH and the ratios of BCFAs to either acetate or butyrate performed the best to differentiate between patients on 100% EN from <100% EN. A ratio of isobutyrate (IC4) to C2> 0.039 and a ratio of IC4 to C2+C4> 0.035 both produced a sensitivity, specificity, and positive predictive value (PPV) of 92%, 83% and 79%, respectively to differentiate between 100% EN vs. all other groups. A faecal pH> 8.0 produced a sensitivity, specificity and PPV of 84%, 86% and 81%, respectively. Findings using machine learning were better than those using ROC curve analysis. Two models were generated; one which includes all faecal metabolites (Laboratory GENIE, L-GENIE), and which produced a sensitivity, specificity and positive predictive value (PPV) of 88%, 94%, and 92%, respectively and a second one (Clinical GENIE, C-GENIE) which considers only faecal pH as the input data and which produced a sensitivity, specificity and PPV of 84%, 86% and 81% (Figure 1). Validation of GENIE models in children with CD found that C-GENIE outperformed L-GENIE, producing a sensitivity, specificity and PPV of 85%, 88% and 88%, respectively (Table 1). Figure 1: Glasgow Exclusive Enteral Nutrition Index of Compliance. Table 1: Results of validation of the GENIE model in children with Crohn’s disease (CD) during treatment with 100% EN and after return to unrestricted diet and compared to the development cohort of healthy adults. Conclusion GENIE can predict adherence to 100% EN in patients with CD in both the clinical and research settings. It may complement conventional dietary assessment and inform clinical decision, especially in patients who are not in remission.
Background Exclusive enteral nutrition (EEN) and partial enteral nutrition (PEN), replacing at least 50% of the energy intake with formula, remain the only evidence-based dietary therapies in the management of Crohn’s disease (CD). Nonetheless, emerging solid food-based dietary therapies are being researched to offer equally effective, but more palatable alternatives. We assessed the perceptions of adults with CD towards EEN, 50% PEN, and novel dietary therapies within a cross-sectional questionnaire survey. Methods The 26-question anonymous survey with a pre-paid return envelope was mailed to 300 adult patients with CD treated with biologics under the care of the NHS Greater Glasgow & Clyde. A reminder was resent three months later. Responses to open-ended questions regarding concerns about 50% PEN use were analysed independently by two researchers using thematic analysis. Results One-hundred and sixty patients (85/160, 53% female) completed and returned the survey (response rate: 53%). Forty-two percent (67/158) had already followed some form of an exclusion diet, with low spice (32/158, 20%) and low fibre (24/158, 15%) diets being the most popular. Although only a quarter of patients believed that EEN or PEN could help with their CD (42/157, 27%), the majority believed that diet could help (84/157, 54%), with another 13% (21/157) reporting already using diet for CD management. Although only around half of the patients were willing to try EEN (80/157, 51%), the majority were willing to try PEN instead (124/157, 79%) (EEN vs. PEN chi-square: P<.001). Most patients preferred to follow an exclusion diet meal plan to prepare at home (65/154, 42%) compared to EEN or PEN (53/153, 34%). Similarly, most patients preferred to follow a meal plan to prepare at home (76/151, 50%) rather than a meal plan with pre-made meals delivered (59/151, 39%). When asked about preferences related to PEN use, most patients reported that they would prefer to follow a flexible meal plan, allowing them to choose meals to replace to fit their lifestyle (92/153, 60%). The most commonly reported concerns about PEN identified within the thematic analysis were taste/palatability (25%, 34/136), satiety/hunger (22%, 30/136), taste fatigue (14%, 19/136), and impact on social life (14%, 19/136). Conclusion Most adult patients would prefer to follow an exclusion diet meal plan rather than EEN or 50% PEN. However, the majority would try 50% PEN which allows for more flexibility and may be easier to comply with than EEN.
Background Exclusive enteral nutrition (EEN) is an established treatment for the induction of clinical remission in children with active Crohn’s disease (CD). However, the benefit of partial enteral nutrition (PEN), in which only some diet is replaced with enteral nutrition, is not well-documented for the management of CD. This review explored the effectiveness of PEN as sole or adjunctive induction and maintenance therapy in patients with CD. Methods The protocol for this review was registered on PROSPERO (https://www.crd.york.ac.uk/prospero/ protocol ID: CRD42021239325). Literature search was conducted using PubMed, Ovid Embase, Cochrane Controlled Register of Trials and Cumulative Index to Nursing and Allied Health Literature electronic bibliographic databases. Eligible study designs included: randomised control trials (RCTs), prospective, retrospective, and case control studies. Level of evidence was assessed with CASP tools with an emphasis on study design, and assessment of compliance and objective disease activity biomarkers. Two researchers evaluated each paper separately and when needed, consensus was resolved by a third. Results 56 articles met the inclusion criteria, grouped under the following 6 distinct areas for PEN use in CD: 1) induction treatment; 2) maintenance treatment; 3) prevention of post-operative recurrence; 4) prevention of loss of response (LOR) to anti-TNFα therapies; 5) nutritional rehabilitation; 6) improvement of quality of life (QOL). Low-quality evidence suggests PEN may improve disease activity in patients with active CD; treatment efficacy was observed to be better in studies using higher proportions of energy intake from PEN. Good quality evidence suggests PEN combined with exclusion diets may be effective in active CD. However, most available studies originated from a single research group, and the additional benefits of exclusion diets over PEN are unclear, particularly as most studies used either high PEN volumes (>75% of energy requirements), or EEN prior to PEN initiation. Good quality evidence shows that PEN at high volumes (≥35–50%) may prolong medically or surgically induced remission and improve the nutritional status of patients with malnutrition or growth delay. Low-quality evidence suggests that PEN may improve response and remission rates to infliximab therapy in CD. Three retrospective studies found that concomitant PEN with anti-TNFα therapies could prevent LOR. Some evidence indicates that PEN is associated with better QOL in patients with active disease or in remission. Conclusion PEN may have a beneficial role in various aspects of CD management; however, more robust data including RCTs are needed before specific recommendations can be made.
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