Gluten-Free diet tested as back pain remedy
NCT ID NCT03017716
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looks at whether a gluten-free diet can reduce inflammatory back pain. Researchers will split 50 people into two groups: one gets standard treatment, the other adds a gluten-free diet for a year. They'll measure pain levels and immune markers to see if the diet makes a difference.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- gluten-free diet
- What this could lead to
- If it works, this could point toward a simple dietary change to help manage inflammatory back pain, especially for those with gluten sensitivity.
- What could go wrong
- This is a small, early-stage study with only 50 people. It's not yet recruiting, so results are far off. The diet may not help everyone, and sticking to it can be hard.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Jul 2026
An estimate. Start dates often move.
- Expected to finish
-
Jan 2028
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 65 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Inflammatory back pain are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
2 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Department of Internal Medicine, Giovanni Paolo II Hospital of Sciacca
Sciacca, Agrigento, 92019, Italy
-
Department of Internal Medicine, University Hospital of Palermo
Palermo, Palermo, 90129, Italy