What if therapy could begin with a simpler, easier diet?

A new CEGIR Consortium of Eosinophilic Gastrointestinal Disease Researchers study, funded by the National Institutes of Health, has found eliminating just animal milk from the diet of adults with eosinophilic oesophagitis EoE is as effective as the traditional 6FED (6 Food Elimination) diet therapy of eliminating six food groups including animal milk, wheat, egg, soya, fish/shellfish and peanut/tree nuts. 

Defining the effectiveness of removing fewer foods is of great importance to both patients and the healthcare professionals that treat them. Restricted diets are difficult to sustain due to expensive free-from foods, the impact on patients' and their families' quality of life, and the exhaustive process of having biopsies taken after each food introduction trial. 

With the aim of reducing the burden of the traditional 6FED diet, several small, non-randomised studies have investigated removing 1-5 of the most common food antigens from the diet to treat EoE, with some success. However, the relative risks and benefits of eliminating many foods versus a few foods at the start of diet-based therapy remained unclear. 

Inspired by CEGIR’s patient advocacy groups, researchers set out to answer the question: what if therapy could begin with a simpler, easier diet?

The trial

The study took place across 10 sites in the USA. It included 129 EoE patients aged 18-60 who were experiencing symptoms in the month before enrolment and had active disease confirmed by biopsies within the 12-week screening period.

It is important to note they had not received treatment of oral swallowed steroids 2 months prior or systemic steroids 3 months prior, but could remain on proton pump inhibitors and antihistamines if this was part of their existing treatment plan.

Participants were assigned at random to either the 1FED, which eliminated only animal milk from the diet, or the traditional 6FED diet.

They followed their assigned diet for six weeks, then underwent an upper endoscopy exam and an oesophageal tissue biopsy. If the number of eosinophils in the tissue indicated that EoE was in remission, the participant exited the study.

The results

34% of participants on 1FED and 40% of participants on 6FED achieved clinical remission of <15 eosinophils per high power field (eos/hpf) after six weeks of diet therapy.

The two diets also had a similar impact across several other measures, including reduction in EoE symptoms and effect on quality of life. Thus, 1FED and 6FED were equally effective at treating EoE, an unexpected finding.

What happened when removing milk did not work?

If EoE was not in remission after six weeks, participants who had been on 1FED could advance to 6FED. Those who had been on 6FED could take topical swallowed steroids. Both groups continued for six weeks, followed by a repeat exam with tissue biopsy.

The results showed that nearly half of the people who did not respond to 1FED achieved remission with the more restrictive 6FED, and that more than 80% of the non-responders to 6FED achieved remission with oral steroids.

Conclusion

CEGIR researchers concluded that this exciting new evidence means that removing animal milk is a reasonable first-line diet therapy option to offer adults with EoE, thus reducing the challenges of cutting out multiple foods where diet is their chosen treatment choice. 

This finding supports a step-up approach to remove more foods as necessary, it also concludes that other therapies are available for people who did not achieve remission after 1FED or 6FED.

References

• KL Kliewer et al. 'One-food versus six-food elimination diet therapy for the treatment of eosinophilic oesophagitis: a multicentre, randomised, open-label trial.' The Lancet Gastroenterology & Hepatology
  
  
• Stephen Attwood. 'Bringing dietary therapy for eosinophilic oesophagitis under scientific scrutiny' The Lancet Gastroenterology & Hepatology

If you are an EoE patient and considering an elimination diet always discuss it with your specialist healthcare provider before avoiding foods.

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