Inflammatory Back Pain and Gluten Free Diet

Launched by UNIVERSITY OF PALERMO · Jan 9, 2017

Keywords

ClinConnect Summary

This clinical trial is exploring how a gluten-free diet (GFD) might help patients who suffer from inflammatory back pain (IBP). IBP is a type of back pain that usually gets better with exercise and is often accompanied by morning stiffness. The study aims to find out if patients with IBP will experience less pain and better overall health if they follow a GFD, compared to those who receive standard treatments for their back pain. Researchers will be looking at two groups: one receiving standard treatment and the other receiving standard treatment plus a gluten-free diet for at least a year. They will also investigate how common IBP is in patients with celiac disease or non-celiac gluten sensitivity.

To join the study, participants need to meet specific criteria. They must have a confirmed diagnosis of IBP based on certain symptoms, and they should either have celiac disease or meet the criteria for non-celiac gluten sensitivity. Eligible participants will be aged between 18 and 75 years and must not have other serious health issues that could affect the study. Those who take part can expect regular check-ins with researchers to monitor their progress and experience the effects of the diet on their symptoms. This trial is not yet recruiting, but it could provide valuable insights for people struggling with inflammatory back pain.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• To diagnose IBP the standard Berlin Criteria will be adopted. IBP is defined by at least 2 positive responses among four items:
• • morning stiffness \>30 min of duration
• • improvement in back pain with exercise but not with rest
• • awakening because of back pain during the second half of the night only
• • alternating buttock pain.
• To diagnose CD the standard criteria will be adopted. All the patients will meet the following criteria:
• • positive serum anti-transglutaminase (anti-tTG) and anti-endomysium (EmA) immunoglobulin (Ig)A and IgG antibodies
• • presence of intestinal villous atrophy.
• To diagnose NCWS the recently proposed criteria will be adopted. All the patients will meet the following criteria:
• • negative serum anti-transglutaminase (anti-tTG) and anti-endomysium (EmA) immunoglobulin (Ig)A and IgG antibodies
• • absence of intestinal villous atrophy
• • negative IgE-mediated immune-allergy tests to wheat (skin prick tests and/or serum specific IgE detection)
• • resolution of the IBS symptoms on standard elimination diet, excluding wheat, cow's milk, egg, tomato, chocolate, and other self-reported food(s) causing symptoms
• • symptom reappearance on double-blind placebo-controlled (DBPC) wheat challenge. As the investigators previously described in other studies, DBPC cow's milk protein challenge and other "open" food challenges will be performed too.
• Exclusion Criteria:
• Exclusion criteria for NCWS diagnosis will be:
• • positive EmA in the culture medium of the duodenal biopsies, also in the case of normal villi/crypts ratio in the duodenal mucosa
• • self-exclusion of wheat from the diet and refusal to reintroduce it before entering the study
• • other previously diagnosed gastrointestinal disorders
• • other previously diagnosed rheumatic diseases
• • nervous system disease and/or major psychiatric disorder
• • physical impairment limiting physical activity.