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Role of adjuvant Crohn’s disease exclusion diet plus enteral nutrition in asymptomatic pediatric Crohn’s disease having biochemical activity: A randomized, pilot study

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Abstract

Background

Conventional therapy can result in remission in mild-moderate pediatric Crohn’s disease (CD). However, some patients experience loss of response to biological drugs despite increased dosage.

Methods

We planned to determine that CD exclusion diet plus partial enteral nutrition offers additional benefits in asymptomatic children with CD having elevated fecal calprotectin. A randomized, open-label, pilot, controlled interventional study was conducted in children with CD while on medical treatment and elevated fecal calprotectin on routine testing. Patients continued their medications and were randomized into a group that received CD exclusion diet plus partial enteral nutrition for 12 weeks and one that continued a regular diet.

Results

Twenty-one patients participated: 11 received CD exclusion diet plus partial enteral nutrition and 10, regular diet. Median fecal calprotectin in the CD exclusion diet plus partial enteral nutrition decreased in 9/11 to 50% of baseline, remaining practically unchanged in the regular diet, except for two patients (p = 0.005). Body mass index z-score increased in the CD exclusion diet plus partial enteral nutrition. Only 1/11 patients in the CD exclusion diet plus partial enteral nutrition group, while 4/10 in the regular diet, experienced clinical relapse (p = 0.149). Only one patient in the CD exclusion diet plus partial enteral nutrition, while eight in the regular diet, were considered to need their biologic treatment intensified (p = 0.005); 2/11 in the CD exclusion diet plus partial enteral nutrition had the dose or frequency of the biologic reduced vs. none (0/10) in the regular diet group. The short Pediatric Crohn’s Disease Activity Index and anthropometry showed no significant changes in either group.

Conclusions

Diet therapy could be a useful addition to medications in children with CD in apparent remission, but elevated fecal calprotectin.

Trial registration

Clinical trial number: NCT05034458.

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Acknowledgements

The authors wish to thank Anabella Famiglietti, R.D., from the Hospital Italiano of Buenos Aires and Rocio Viollaz, R.D., from the Hospital Sor Ludovica de la Plata, La Plata, Provincia de Buenos Aires, Argentina, for dietary counseling to patients in the study; Vanina Pagotto, M.D., from the Hospital Italiano of Buenos Aires, for statistical analyses, Nestle Health Science Argentina for the donation of the special formula used, Leigh Emerson, Robert Shulman, M.D. and Richard Kellermayer, M.D., for editorial assistance and critical review of the manuscript.

Funding

This research was funded in part through an International Cooperation Grant in Child Nutrition of the Spanish Society of Gastroenterology, Hepatology and Pediatric Nutrition 2021 and through the Young Investigator Award of the Latin American Society of Gastroenterology, Hepatology and Pediatric Nutrition 2022.

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Authors and Affiliations

  1. Pediatric Gastroenterology Hepatology and Liver Intestinal Transplantation Unit, Hospital Italiano de Buenos Aires, Juan D. Peron 4190, C1199ACH, Buenos Aires, Argentina

    Maria Soledad Arcucci, Marina Orsi, Julieta Gallo, Veronica Busoni & Carlos Lifschitz

  2. Pediatric Gastroenterology Service, Hospital de Niños Sor Ludovica de La Plata, 1631,14th St, 1900, La Plata, Argentina

    Lorena Menendez & Luciana Guzman

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  1. Maria Soledad Arcucci
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Contributions

Maria Soledad Arcucci: study design, data collection, data interpretation, writer of the first manuscript draft, editing and approval of final manuscript. Lorena Menendez: study design, data collection, data interpretation, manuscript editing and approval of final manuscript. Marina Orsi: study design, data interpretation, manuscript editing and approval of final manuscript. Julieta Gallo: study design, data collection, data interpretation, manuscript editing and approval of final manuscript. Luciana Guzman: study design, data collection, data interpretation, manuscript editing and approval of final manuscript. Veronica Busoni: study design, data interpretation, manuscript editing and approval of final manuscript. Carlos Lifschitz: study design, data interpretation, manuscript editing and approval of final manuscript.

Corresponding author

Correspondence to Maria Soledad Arcucci.

Ethics declarations

Conflict of interest

MSA, LM, MO, JG, LG, VB and CL declare no competing interests.

Ethics statement

The study was performed conforming to the Helsinki Declaration of 1975, as revised in 2000 and 2008 concerning human and animal rights, and the authors followed the policy concerning informed consent as shown on Springer.com.

Disclaimer

The authors are solely responsible for the data and the content of the paper. In no way, the Honorary Editor-in-Chief, Editorial Board Members, the Indian Society of Gastroenterology or the printer/publishers are responsible for the results/ findings and content of this article.

Additional information

Trial identification number

PRIISA.BA https://www.buenosaires.gob.ar/salud/docencia-investigacion-y-desarrollo-profesional/priisaba/registro-publico-de-investigaciones number 4384.

Clinical trials

https://clinicaltrials.gov/ct2/show/NCT05034458?term=arcucci&cond=Crohn+Disease&cntry=AR&draw=2&rank=1 number 5922

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Arcucci, M.S., Menendez, L., Orsi, M. et al. Role of adjuvant Crohn’s disease exclusion diet plus enteral nutrition in asymptomatic pediatric Crohn’s disease having biochemical activity: A randomized, pilot study. Indian J Gastroenterol 43, 199–207 (2024). https://doi.org/10.1007/s12664-023-01416-x

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