Evidence map›Paper›PMID 39967287›Full record

Trial reportAlimentary pharmacology & therapeutics2025

Clinical Trial: The Effects of Emulsifiers in the Food Supply on Disease Activity in Crohn's Disease: An Exploratory Double-Blinded Randomised Feeding Trial.

Jessica A Fitzpatrick, Peter R Gibson, Kirstin M Taylor, Ellen J Anderson, Antony B Friedman, Zaid S Ardalan, Rebecca L Smith, Emma P Halmos

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Alimentary pharmacology & therapeutics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed.

  1. The Challenges of Performing Controlled Trials of Diet Therapies in Gastroenterology.JGH open : an open access journal of gastroenterology and hepatology · 2026
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Jessica A FitzpatrickDepartment of Gastroenterology, School of Translational Medicine, Monash University and Alfred Health, Melbourne, Victoria, Australia.ORCID https://orcid.org/0000-0002-7811-8135
Peter R GibsonDepartment of Gastroenterology, School of Translational Medicine, Monash University and Alfred Health, Melbourne, Victoria, Australia.ORCID https://orcid.org/0000-0001-9108-1712
Kirstin M TaylorDepartment of Gastroenterology, School of Translational Medicine, Monash University and Alfred Health, Melbourne, Victoria, Australia.ORCID https://orcid.org/0000-0002-1010-8504
Ellen J AndersonDepartment of Gastroenterology, School of Translational Medicine, Monash University and Alfred Health, Melbourne, Victoria, Australia.ORCID https://orcid.org/0009-0009-5347-9573
Antony B FriedmanDepartment of Gastroenterology, School of Translational Medicine, Monash University and Alfred Health, Melbourne, Victoria, Australia.ORCID https://orcid.org/0000-0002-8106-1280
Zaid S ArdalanDepartment of Gastroenterology, School of Translational Medicine, Monash University and Alfred Health, Melbourne, Victoria, Australia.ORCID https://orcid.org/0000-0001-6952-0985
Rebecca L SmithDepartment of Gastroenterology, School of Translational Medicine, Monash University and Alfred Health, Melbourne, Victoria, Australia.ORCID https://orcid.org/0000-0002-8033-0848
Emma P HalmosDepartment of Gastroenterology, School of Translational Medicine, Monash University and Alfred Health, Melbourne, Victoria, Australia.ORCID https://orcid.org/0000-0002-6063-5118

Funding

Crohn's and Colitis AustraliaCrohn's and Colitis FoundationEva and Tom Breuer FoundationNational Health and Medical Research Council
6 · The paper itself

Abstract

backgroundAdvice to avoid dietary emulsifiers in Crohn's disease (CD) is based on preclinical data.

aimsTo examine the effect of diets high (HED) and low (LED) in emulsifiers in the food supply on disease activity in CD.

methodsIn a double-blinded, randomised feeding study, we randomised adults with symptomatic, sonographically active CD with ileal involvement on ≥ 2 months' stable medical therapy to 4 weeks of a HED or LED modelled on Australian healthy eating guidelines. We measured the Harvey-Bradshaw Index (HBI), sonographic indices (IBUS-SAS, bowel wall thickness), quality of life (QOL) and fatigue at baseline and study completion.

resultsWe randomised 24 patients, mean age 37 (95% CI 32, 41) years, 12 male, HBI 6 (6, 8), bowel wall thickness 6.0 (5.5-6.6) mm. Adherence was > 95%. Clinical remission (HBI < 5) occurred in 9/12 on HED and 7/12 on LED; 2 and 3, respectively, withdrew early with increasing gastrointestinal symptoms. IBUS-SAS fell from 51 (35, 68) to 33 (15, 51) on HED (p = 0.014) and from 57 (38, 76) to 44 (29, 59) on LED (p = 0.01). Bowel wall thickness reduced by 34% on HED and 15% on LED in those who completed the study. QOL and fatigue improved on both diets (p ≤ 0.05). There were no statistically significant differences in outcomes between diets.

conclusionsIn the context of a healthy diet, the emulsifier content had no influence over disease activity over 4 weeks in patients with CD. Recommendations to avoid emulsifiers in patients with active CD are not supported. Australian New Zealand Clinical Trials Registry (ACTRN12619001099112).

Indexed as

Crohn DiseaseEmulsifying AgentsAdultDouble-Blind MethodFemaleHumansMaleMiddle AgedQuality of LifeTreatment OutcomeUltrasonographyYoung AdultEmulsifying Agentsfood additiveinflammationinflammatory bowel disease

Identifiers

PMID39967287
PMCPMC11950802

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.