Trial reportIndian journal of gastroenterology : official journal of the Indian Society of Gastroenterology2024
Role of adjuvant Crohn's disease exclusion diet plus enteral nutrition in asymptomatic pediatric Crohn's disease having biochemical activity: A randomized, pilot study.
Trial report in Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05034458 (Diet as Adjuvant Therapeutics in the Era of Biologics in Pediatric-onset Crohn's Disease.), which is not on this map. Cited by 10 papers, 4 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Diet as Adjuvant Therapeutics in the Era of Biologics in Pediatric-onset Crohn's Disease.
Who cites it
10 citing papers in PubMed, 4 syntheses or guidelines pooled it, 11 citations in OpenAlex.
- Meta-Analysis: Crohn's Disease Exclusion Diet for Induction and Maintenance in Crohn's Disease.Alimentary pharmacology & therapeutics · 2026Pooled it
- Pooled it
- Partial Enteral Nutrition in the Management of Crohn's Disease: A Systematic Review and Meta-Analysis.Journal of Crohn's & colitis · 2025Pooled it
- The efficacy of dietary therapies in modulating inflammatory biomarkers, clinical remission and quality of life in patients with inflammatory bowel disease: a network meta-analysis of 15 interventions.Frontiers in nutrition · 2025Pooled it
- Diet and Gut Microbiota in Inflammatory Bowel Disease: A Clinical and Nutritional Perspective.Pharmaceuticals (Basel, Switzerland) · 2026Review
- The attitudes and beliefs of Australasian pediatric gastroenterologists and dietitians toward the Crohn's disease exclusion diet.JPGN reports · 2026Article
- Nutritional Approach in Pediatric Patients with Inflammatory Bowel Disease: Treatment, Risk and Challenges.Nutrients · 2025Review
- Effects of Modified Crohn's Disease Exclusion Diet as Adjunctive Therapy on Clinical Remission and Nutrition in Pediatric Crohn's Disease: A Real-World Study from China.Children (Basel, Switzerland) · 2025Article
- Whole-food diet therapies for children with Crohn's disease: a systematic review.Therapeutic advances in gastroenterology · 2025Review
- Cultural Perspectives on the Efficacy and Adoption of the Crohn's Disease Exclusion Diet across Diverse Ethnicities: A Case-Based Overview.Nutrients · 2024Article
Corrections and comments
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Authors and funding
7 authors at 2 institutions in 1 country.
Funding
Abstract
backgroundConventional 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.
methodsWe 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.
resultsTwenty-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.
conclusionsDiet therapy could be a useful addition to medications in children with CD in apparent remission, but elevated fecal calprotectin.
trial registrationClinical trial number: NCT05034458.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.