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TASTY & HEALTHY FLEXIBLE DIET IS EFFECTIVE FOR INDUCING REMISSION IN CHILDREN AND YOUNG ADULTS WITH MILD-MODERATE CROHN'S DISEASE: A RANDOMIZED CONTROLLED TRIAL WITH EXCLUSIVE ENTERAL NUTRITION AS A COMPARATOR

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Introduction

Exclusive enteral nutrition (EEN) is effective for inducing remission in Crohn's disease (CD) but adherence is challenging. CD-Exclusion Diet (CDED) may be a suitable alternative, but it is structured with mandatory ingredient and requires partial enteral nutrition (PEN). The Tasty&Healthy (T&H) diet excludes processed food, gluten, red meat, and dairy (except for plain yogurt); otherwise, it has no mandatory ingredients and does not require PEN.

Aims & Methods

In this clinician-blinded randomized controlled trial we aimed to assess the tolerability and effectiveness of the T&H diet vs. EEN in children and young adults with CD.
Patients aged 6-25 years with mild-moderate CD were randomized into T&H or EEN for 8-weeks; both groups received weekly dietary support. Explicit nutritional and clinical data, as well as calprotectin were collected at baseline and every 2-weeks thereafter. Tolerability was defined as the discontinuation of the intervention for lack of adherence, or low adherence judged by weekly interviews and 24-hour intake diary. Effectiveness outcomes included clinical remission (i.e. wPCDAI/CDAI), the MINI index that reflects mucosal inflammation (mucosal healing is defined by MINI<8 points), CRP, ESR and calprotectin. Those not tolerating either intervention during the first 24 hours were excluded; otherwise, both ITT and per-protocol (PP) analyses are presented.

Results

Of the 97 randomized patients, 14 were excluded during the first 24 hours and 83 were analyzed, 41 in the T&H arm and 42 in the EEN arm (mean age 14.5±3.7 years). The primary endpoint was met with 36 (88%) patients tolerating T&H vs. 22 (52%) tolerating EEN (OR 6.3 (95%CI 2.2-22; p<0.001).
Week-8 clinical remission rates were similarly high in both groups whether analyzed by ITT (56% in the T&H vs. 38% in the EEN; p=0.1) or PP (67% vs. 76%; p=0.47). The mean MINI index improved significantly from baseline in both the EEN (14.9±5.6 to 7.1±6.1; p<0.001) and T&H (14.5±4.6 to 8.7±6.4; p<0.001) arms, without a difference across groups (p=0.47). In the ITT analysis, MINI<8 at week 8 was higher in the T&H arm (54%) than the EEN arm (41%; OR 2.6 (95%CI 1.1-6.3); p=0.026). Calprotectin decreased significantly from baseline in both arms, without a difference across groups at week-8 (calprotectin <250 was noted in 38% with T&H vs 41% with EEN; p=0.84). There were also no differences between EEN and T&H in ESR and CRP, both improving significantly from baseline (both p<0.01).
There were 3 adverse events reported in this trial with at least possible association with the intervention, all mild, 2 in the EEN arm (nausea and dizziness) and 1 in the T&H arm (constipation).

Conclusion

T&H is a flexible exclusion diet, with similar effectiveness to EEN in mild-moderate CD and higher tolerance. The diet does not include mandatory foods and does not require PEN.

Disclosure

This study was funded by a grant from The Helmsley Charitable Trust

TASTY & HEALTHY FLEXIBLE DIET IS EFFECTIVE FOR INDUCING REMISSION IN CHILDREN AND YOUNG ADULTS WITH MILD-MODERATE CROHN'S DISEASE: A RANDOMIZED CONTROLLED TRIAL WITH EXCLUSIVE ENTERAL NUTRITION AS A COMPARATOR

Yonat Aharoni Frutkoff 1, Luba Plotkin 1, Zivia Shavit-Brunschwig 1, Gili Focht 1, Raffi Lev-Tzion 1, Oren Ledder 1, Amit Assa 1, Dotan Yogev 1, Esther Orlanski-Meyer 1, Efrat Broide 2, Jarosław Kierkuś 3, Ben Kang 4, Batia Weiss 5, Marina Aloi 6, Tobias Schwerd 7, Anne Griffiths 8, Dror Shouval 9, Dan Turner 1

1 Shaare Zedek Medical Center, Jerusalem, Israel

2 Assaf Harofeh Medical Center, Tel-Aviv University, Zerifin, Israel

3 The Childrens' Memorial Health Institute, Warsaw, Poland

4 Kyungpook National University Children's Hospital, School of Medicine, Kyungpook National University, Daegu, Korea, Republic of

5 Edmond and Lily Safra Children's Hospital, The Chaim Sheba Medical Center, Ramat Gan, Israel

6 Sapienza University of Rome Dept. of Pediatric Gastroenterology SIGENP IBD Group, Rome, Italy

7 LMU München, Munich, Germany

8 The Hospital for Sick Children, University of Toronto, Toronto, Canada

9 Schneider Children's Medical Center of Israel, Petah Tikva, Israel

Event

UEG Week Vienna 2024

Topics

IBD Mechanisms & Personalised Medicine Paediatrics

Submission format

Late-Breaking Abstract

Session

Crohn’s disease hot of the press: Late-breaking abstracts

Citation

United European Gastroenterology Journal 2024; 12 (Supplement 8)

Published

2024

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Green endoscopy: Step by step to a paper free endoscopy unit

Konstantinos Triantafyllou 1

1 Attikon University General Hospital, Athens, Greece

Event

UEG Week Berlin 2025

Topics

Nurses

Session

Green endoscopy: What makes sense?

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

UEG Poster

Standard Poster

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Introduction

The number of gastroesophageal reflux disease (GERD) patients that do not improve sufficiently by standard treatment is relatively high. Multichannel intraluminal impedance and pH monitoring (MII-pH) is the gold standard for diagnosing GERD, and it can be useful for selecting secondary treatment. However, in some cases, secondary treatments are not remarkably effective even when selected based on the diagnosis. On the other hand, the clinical value of the symptom–reflux association (SRA) obtained using MII-pH remains unknown.

Aims & Methods

The current study aimed to investigate the effect of SRA on the efficacy of secondary treatment in refractory true GERD.
This study included patients who underwent MII-pH monitoring for evaluating proton pump inhibitor (PPI)- or potassium-competitive acid blocker (P-CAB)-refractory GERD symptoms and who were diagnosed with abnormal acid reflux (acid exposure time > 6%). Patients with a positive symptom index (SI) and symptom association probability (SAP) on the MII-pH monitoring were included in the SRA-positive group and the remaining ones in the SRA-negative group. The differences in the subsequent treatment efficacy between the two groups were retrospectively analyzed. Treatment efficacy was evaluated using the Frequency Scale for the Symptoms of GERD (FSSG) questionnaire.

Results

Of the 192 patients with PPI-/PCAB-refractory GERD, 41 (21.4%) were diagnosed with abnormal acid reflux. Among them, 30 (7 in the SRA-positive group and 23 in the SRA-negative group) underwent symptom assessments before and after treatment. The SRA-positive group had a significantly greater symptom improvement after treatment compared with the SRA-negative group (FSSG score changes: −13.0 ± 6.5 vs −5.4 ± 8.2, p = 0.016).

Conclusion

SRA evaluation is effective in predicting secondary treatment outcomes in patients with abnormal acid reflux.

EFFICACY OF THE SYMPTOM–REFLUX ASSOCIATION TO DETERMINE SECONDARY TREATMENT FOR PPI-/P-CAB REFRACTORY TRUE GERD PATIENTS

Satsuki Takahashi 1, Tomoaki Matsumura 2, Michiko Sonoda 2, Tomomi Ozaki 2, Tatsuya Kaneko 2, Ryosuke Horio 2, Chihiro Goto 2, Akane Kurosugi 2, Tsubasa Ishikawa 2, Yuki Ohta 2, Takashi Taida 2, Atsuko Kikuchi 2, Kenichiro Okimoto 2, Jun Kato 2

1 Chiba University Hospital, Chiba, Japan|||Queen Mary University of London, London, United Kingdom

2 Chiba University Hospital, Chiba, Japan

Conference

UEG Week Berlin 2025

Topics

Oesophagus

Submission format

Abstract

Session

OESOPHAGEAL, GASTRIC AND DUODENAL (Posters)

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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Autoimmunity in the liver

Bogdan Dumitru Procopet 1

1 University of Medicine and Pharmacy "Iuliu Hatieganu", Cluj-Napoca, Romania

Event

UEG Week Copenhagen 2023

Topics

Hepatobiliary Immunology Pancreas

Session

Autoimmunity in HPB

Published

2023

UEG Presentation

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EFFICACY OF THE THIRD-LINE CHEMOTHERAPY IN PATIENTS WITH ADVANCED PANCREATIC CANCER

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Introduction

First-line FOLFIRINOX or gemcitabine plus nab-paclitaxel (GNP) have improved the survival outcomes of patients with advanced pancreatic cancer (APC) and nano-liposomal irinotecan (nal-IRI) plus 5-FU/leucovorin is proven as the second-line agents.

Aims & Methods

The current study aims to assess the efficacy of third-line palliative chemotherapy in APC.
Medical records were retrospectively reviewed in a single tertiary hospital between 2012 and 2021. We enrolled patients with APC who experienced progression after the second-line chemotherapy following the first-line FOLFIRINOX or GNP. To define the efficacy of the third-line chemotherapy, Cox-regression analysis was performed. To identify the clinical factors affecting the survival, multivariable logistic regression analysis was also performed.

Results

Total 141 patients were enrolled. The median age at diagnosis was 61.8 years (range 36.0 – 86.0), and males were 54.9% (n=78). The first-line chemotherapy regimen was FOLFIRINOX (95, 67.4%) and GNP (46, 32.6%). The second-line chemotherapy regimen was FOLFIRINOX (38, 27.0%), GNP (74, 52.5%), and others (29, 20.4%). Regarding the third-line regimen, TS-1 and nal-IRI plus 5-FU/leucovorin were 69 (27.0%) and 53 (37.6%). The median overall survival (OS) from diagnosis was 18.0 months (95% confidence interval (CI), 15.3 – 20.7). The median OS and median progression-free survival after the third-line treatment were 14.6 (95% CI, 12.1 – 17.0) and 7.3 weeks (95% CI, 6.3– 8.3). About the best tumor response during the third-line chemotherapy, there was no complete response, 2 (1.4%) with a partial response, 41 (29.1%) with stable disease, and 80 (56.7%) with progressive disease. Consequently, the disease control rate in the third-line treatment was 30.5%. Of the patients with the third-line chemotherapy, the following clinical factors affected OS; ECOG of 2 at third-line chemotherapy (HR: 2.64, 95% CI: 1.58-4.42; p <0.001), serum CA19-9 level ≥ 1,000 U/ml before the third-line chemotherapy (HR: 1.67, 95% CI: 1.11-2.52; p=0.014), duration of the second-line chemotherapy < 19 weeks (HR: 1.51, 95% CI: 1.03-2.21; p=0.034), and peritoneal seeding before the third-line chemotherapy (HR: 1.53, 95% CI: 1.03-2.25; p=0.033).

		Univariable analysis		Multivariable analysis
		Hazard ratio (95% CI)	P	Hazard ratio (95% CI)	P
Gender	Male	1.425 (1.010-2.010)	0.044	1.330 (0.911-1.943)	0.140
ECOG at third-line CTx	Score 2	2.257 (1.413-3.607)	0.001	2.639 (1.576-4.419)	<0.001
CA 19-9 level before third-line CTx	≥1,000U/ml	1.540 (1.061-2.235)	0.023	1.672 (1.109-2.522)	0.014
Duration of second-line CTx	< 19 weeks	1.749 (1.215-2.516	0.003	1.508 (1.031-2.206)	0.034
Peritoneal seeding before third-line CTx	Positive	1.429 (1.009–2.023)	0.044	1.526 (1.034-2.253)	0.033

Conclusion

The current study suggested that proceeding with the third-line chemotherapy could be recommended in some patients. There is no difference in survival rate according to the type of the third-line chemotherapy regimen. ECOG 0 or 1, CA 19-9 <1,000U/ml, duration of second-line chemotherapy ≥ 19 weeks, and no peritoneal seeding showed significantly more benefit from the third-line therapy.

References

1. Conroy T, Desseigne F, Ychou M, Bouche O, Guimbaud R, Becouarn Y, Adenis A, Raoul JL, Gourgou-Bourgade S, de la Fouchardiere C, Bennouna J, Bachet JB, Khemissa-Akouz F, Pere-Verge D, Delbaldo C, Assenat E, Chauffert B, Michel P, Montoto-Grillot C, Ducreux M, Groupe Tumeurs Digestives of U, Intergroup P. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med 2011; 364(19): 1817-1825
2. Von Hoff DD, Ervin T, Arena FP, Chiorean EG, Infante J, Moore M, Seay T, Tjulandin SA, Ma WW, Saleh MN, Harris M, Reni M, Dowden S, Laheru D, Bahary N, Ramanathan RK, Tabernero J, Hidalgo M, Goldstein D, Van Cutsem E, Wei X, Iglesias J, Renschler MF. Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. N Engl J Med 2013; 369(18): 1691-1703
3. Walker EJ, Ko AH. Beyond first-line chemotherapy for advanced pancreatic cancer: an expanding array of therapeutic options? World J Gastroenterol 2014; 20(9): 2224-2236
4. Wang-Gillam A, Hubner RA, Siveke JT, Von Hoff DD, Belanger B, de Jong FA, Mirakhur B, Chen LT. NAPOLI-1 phase 3 study of liposomal irinotecan in metastatic pancreatic cancer: Final overall survival analysis and characteristics of long-term survivors. Eur J Cancer 2019; 108: 78-87