Inflammatory Back PainNCT03017716
Inflammatory Back Pain and Gluten Free Diet
A study testing Gluten free diet in people with Inflammatory Back Pain, run by University of Palermo at 2 sites in Italy.
Trial summary
Articular involvement is the most frequent extra-intestinal manifestation of inflammatory bowel diseases (IBD). IBD-related spondyloarthropathy is mainly characterised by axial involvement (including inflammatory back pain, isolated sacroiliitis and ankylosing spondylitis) but may also be associated with peripheral… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Inflammatory Back Pain
- What is being tested?
- Gluten free diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Jul 2026to 1 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 14Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites
Department of Internal Medicine, University Hospital of Palermo
Palermo, Palermo, 90129
Pasquale Mansueto, MD, +390916554347, pasquale.mansueto@unipa.it
Department of Internal Medicine, Giovanni Paolo II Hospital of Sciacca
Sciacca, Agrigento, 92019
Antonio Carroccio, MD, PhD, +390916554347, acarroccio@hotmail.com
About this study
Articular involvement is the most frequent extra-intestinal manifestation of inflammatory bowel diseases (IBD). IBD-related spondyloarthropathy is mainly characterised by axial involvement (including inflammatory back pain, isolated sacroiliitis and ankylosing spondylitis) but may also be associated with peripheral symptoms (i.e peripheral arthritis, dactylitis and enthesopathy, such as Achilles tendinitis, plantar fasciitis, and chest wall pain). In particular, inflammatory back pain (IBP) is characterised by an insidious onset, improves after exercise but not with rest, and is associated with morning stiffness. Up to now, several criteria sets have been proposed to define IBP. Studies conducted in various populations have confirmed a high sensitivity and specificity for the Berlin criteria. Celiac disease (CD) is an autoimmune systemic disease having among its clinical manifestations frequent symptoms common to rheumatologic diseases. Recently, it has been reported that a consistent percentage of the general population consider themselves to be suffering from problems caused by wheat and/or gluten ingestion, even though they do not have CD or wheat allergy. This clinical condition has been named Non-Celiac Gluten Sensitivity' (NCGS) or Non-celic Wheat Sensitivity (NCWS). The clinical picture of NCWS is characterized by combined gastrointestinal and extra-intestinal or systemic manifestations. Many patients affected with CD and NCWS complain of IBP-like symptoms, which generally improve, together with the other clinical manifestations of the diseases, during a gluten-free diet (GFD). Therefore, the aims of the present study are to investigate 1) the effect of a GFD in IBP patients, randomly assigned to receive standard therapy for IBP or standard therapy for IBP plus GFD, for a period of at least one year, and 2) the prevalence of IBP in CD and in NCWS patients.
Read the detailed description
Articular involvement is the most frequent extra-intestinal manifestation of inflammatory bowel diseases (IBD), frequently follows a course that is independent of the course of intestinal involvement, and its diagnosis mainly relies on clinical evidence and imaging data, because laboratory assessments are rarely useful. More in details, IBD-related arthropathy is one of a group of inflammatory arthritides, known as seronegative spondyloarthropathies, that also includes idiopathic ankylosing spondylitis, reactive arthritis, psoriatic arthritis, and undifferentiated seronegative spondyloarthropathies, all of which are classified on the basis of peripheral arthritis (asymmetrical, predominantly in the lower extremities) and/or inflammatory spinal involvement in IBD patients using the well-known criteria of the European Spondyloarthropathy Study Group. IBD-related spondyloarthropathy is mainly characterised by axial involvement (including inflammatory back pain, isolated sacroiliitis and ankylosing spondylitis) but may also be associated with peripheral symptoms (i.e peripheral arthritis, dactylitis and enthesopathy, such as Achilles tendinitis, plantar fasciitis, and chest wall pain). In particular, inflammatory back pain (IBP) is characterised by an insidious onset, improves after exercise but not with rest, and is associated with morning stiffness. It may also present as pain during the second half of the night and/or alternating buttock pain. Up to now, several criteria sets have been proposed to define IBP. Firstly, the Calin criteria set was developed in 1977 and has since then been most widely used for defining IBP. The Calin criteria set has no entry criteria and is not based on standardized questions. Studies conducted in various populations have confirmed a high sensitivity for the Calin criteria, but shown much lower specificity than that reported in the original study. Berlin criteria for IBP were derived from a controlled study, including patients with ankylosing spondylitis and mechanical low back pain, who all had chronic low back pain. Berlin criteria are applicable only to those patients with chronic low back pain (>3 months) and age younger than <50 years old. This criteria set yielded a sensitivity of 70% and a specificity of 81% if at least two of the four following criteria were met: morning stiffness of >30-min duration, improvement in back pain with exercise but not with rest, awakening because of back pain during the second half of the night only, and alternating buttock pain. Assessment of Spondyloarthritis International Society (ASAS) has just recently published new criteria for classification of IBP. These were based on the expert judgment of the rheumatologist as the "gold standard" for diagnosing IBP in patients with chronic back pain of unknown origin. These new candidate IBP criteria administered by the interviewing clinician included the domains "improvement with exercise," "nocturnal pain," "age at onset <40 years," and "no improvement with rest." They were then validated in a distinct cohort of patients presenting to the rheumatologist with new-onset back pain and were shown to have a sensitivity of 79.6% and specificity of 72.4%. Celiac disease (CD) is an autoimmune systemic disease having among its clinical manifestations frequent symptoms common to rheumatologic diseases, such as musculoskeletal pain, asthenia, and cognitive fatigue. Recently, it has been reported that a consistent percentage of the general population consider themselves to be suffering from problems caused by wheat and/or gluten ingestion, even though they do not have CD or wheat allergy. This clinical condition has been named Non-Celiac Gluten Sensitivity' (NCGS). In a previous paper the investigators suggested the term 'Non-Celiac Wheat Sensitivity' (NCWS), since it is not known what component of wheat causes the symptoms in NCGS patients, and the investigators also showed that these patients had a high frequency of coexistent multiple food hypersensitivity. The clinical picture of NCWS is characterized by combined gastrointestinal (bloating, abdominal pain, diarrhea and/or constipation, nausea, epigastric pain, gastroesophageal reflux, aphthous stomatitis) and extra-intestinal or systemic manifestations (headache, depression, anxiety, 'foggy mind,' tiredness, dermatitis or skin rash, fibromyalgia-like joint/muscle pain, leg or arm numbness, and anemia). NCWS lacks of specific diagnostic tests, being its diagnosis essentially of exclusion. Many patients affected with CD and NCWS complain of IBP-like symptoms, which significantly affect the patients' quality of life and generally improve, together with the other clinical manifestations of the diseases, during a gluten-free diet (GFD). Therefore, the aims of the present study are to investigate 1) the effect of a GFD in IBP patients, randomly assigned to receive standard therapy for IBP or standard therapy for IBP plus GFD, for a period of at least one year, and 2) the prevalence of IBP in CD and in NCWS patients.
- Conditions
- Inflammatory Back Pain
- Being tested
- Gluten free diet
- Keywords
- Inflammatory back pain, gluten-free diet, celiac disease, non-celiac wheat sensitivity
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gluten free dietOther
The investigators will evaluate the effect of a gluten free diet (GFD) in IBP patients, randomly assigned to receive standard therapy for IBP or standard therapy for IBP plus GFD, for a period of at least one year.
| Study group | Role | What they receive |
|---|---|---|
| IBP patients on standard therapy | No intervention | IBP patients on standard therapy. |
| IBP patients on standard therapy and GFD | Active comparator | IBP patients on standard therapy and GFD Receives: Other: Gluten free diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Musculoskeletal (back pain) evaluation at baseline and after GFD
Musculoskeletal (back pain) evaluation, from baseline at 12 months of GFD, according to the scores calculated on the basis of Visual Analogue Scales for Musculoskeletal (back pain), taking into account whether the patients adhered or not to the GFD.
Measured: Change from baseline at 12 months
Changes in cytokines production from peripheral blood mononuclear (PBMC) at baseline and after GFD
Changes in cytokines production from peripheral blood mononuclear (PBMC), from baseline (i.e. at diagnosis) at 12 months of GFD, taking into account whether the patients adhered or not to the GFD.
Measured: Change from baseline at 12 months
Secondary outcomes (1)
Prevalence of IBP in CD and in NCWS patients.
Prevalence of IBP in CD and in NCWS patients.
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2017 (estimated)
- Study start1 Jul 2026 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Palermo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pasquale Mansueto, University of Palermo
- Investigators
- Antonio Carroccio, PhD, Study director, University of Palermo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03017716
- Sponsor's protocol ID
- ACPM14
- Status last verified
- Jan 2026
- First submitted
- 30 Dec 2016
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mansueto P, Seidita A, D'Alcamo A, Carroccio A. Role of FODMAPs in Patients With Irritable Bowel Syndrome. Nutr Clin Pract. 2015 Oct;30(5):665-82. doi: 10.1177/0884533615569886. Epub 2015 Feb 18.
PubMed 25694210Carroccio A, D'Alcamo A, Mansueto P. Nonceliac wheat sensitivity in the context of multiple food hypersensitivity: new data from confocal endomicroscopy. Gastroenterology. 2015 Mar;148(3):666-7. doi: 10.1053/j.gastro.2014.11.047. Epub 2015 Jan 24. No abstract available.
PubMed 25625764Carroccio A, Soresi M, D'Alcamo A, Sciume C, Iacono G, Geraci G, Brusca I, Seidita A, Adragna F, Carta M, Mansueto P. Risk of low bone mineral density and low body mass index in patients with non-celiac wheat-sensitivity: a prospective observation study. BMC Med. 2014 Nov 28;12:230. doi: 10.1186/s12916-014-0230-2.
PubMed 25430806Mansueto P, Seidita A, D'Alcamo A, Carroccio A. Non-celiac gluten sensitivity: literature review. J Am Coll Nutr. 2014;33(1):39-54. doi: 10.1080/07315724.2014.869996.
PubMed 24533607Carroccio A, Rini G, Mansueto P. Non-celiac wheat sensitivity is a more appropriate label than non-celiac gluten sensitivity. Gastroenterology. 2014 Jan;146(1):320-1. doi: 10.1053/j.gastro.2013.08.061. Epub 2013 Nov 22. No abstract available.
PubMed 24275240Carroccio A, Mansueto P, D'Alcamo A, Iacono G. Non-celiac wheat sensitivity as an allergic condition: personal experience and narrative review. Am J Gastroenterol. 2013 Dec;108(12):1845-52; quiz 1853. doi: 10.1038/ajg.2013.353. Epub 2013 Nov 5.
PubMed 24169272Carroccio A, Mansueto P, Iacono G, Soresi M, D'Alcamo A, Cavataio F, Brusca I, Florena AM, Ambrosiano G, Seidita A, Pirrone G, Rini GB. Non-celiac wheat sensitivity diagnosed by double-blind placebo-controlled challenge: exploring a new clinical entity. Am J Gastroenterol. 2012 Dec;107(12):1898-906; quiz 1907. doi: 10.1038/ajg.2012.236. Epub 2012 Jul 24.
PubMed 22825366Carroccio A, Brusca I, Mansueto P, D'alcamo A, Barrale M, Soresi M, Seidita A, La Chiusa SM, Iacono G, Sprini D. A comparison between two different in vitro basophil activation tests for gluten- and cow's milk protein sensitivity in irritable bowel syndrome (IBS)-like patients. Clin Chem Lab Med. 2013 Jun;51(6):1257-63. doi: 10.1515/cclm-2012-0609.
PubMed 23183757Dougados M, van der Linden S, Juhlin R, Huitfeldt B, Amor B, Calin A, Cats A, Dijkmans B, Olivieri I, Pasero G, et al. The European Spondylarthropathy Study Group preliminary criteria for the classification of spondylarthropathy. Arthritis Rheum. 1991 Oct;34(10):1218-27. doi: 10.1002/art.1780341003.
PubMed 1930310Calin A, Porta J, Fries JF, Schurman DJ. Clinical history as a screening test for ankylosing spondylitis. JAMA. 1977 Jun 13;237(24):2613-4.
PubMed 140252Rudwaleit M, Metter A, Listing J, Sieper J, Braun J. Inflammatory back pain in ankylosing spondylitis: a reassessment of the clinical history for application as classification and diagnostic criteria. Arthritis Rheum. 2006 Feb;54(2):569-78. doi: 10.1002/art.21619.
PubMed 16447233Sieper J, van der Heijde D, Landewe R, Brandt J, Burgos-Vagas R, Collantes-Estevez E, Dijkmans B, Dougados M, Khan MA, Leirisalo-Repo M, van der Linden S, Maksymowych WP, Mielants H, Olivieri I, Rudwaleit M. New criteria for inflammatory back pain in patients with chronic back pain: a real patient exercise by experts from the Assessment of SpondyloArthritis international Society (ASAS). Ann Rheum Dis. 2009 Jun;68(6):784-8. doi: 10.1136/ard.2008.101501. Epub 2009 Jan 15.
PubMed 19147614
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammatory Back Pain and Gluten Free Diet
- ClinicalTrials.gov ID
- NCT03017716
- Acronym / sponsor ID
- ACPM14
- Conditions
- Inflammatory Back Pain
- Keywords
- Inflammatory back pain, gluten-free diet, celiac disease, non-celiac wheat sensitivity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of PalermoUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 11 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Articular involvement is the most frequent extra-intestinal manifestation of inflammatory bowel diseases (IBD). IBD-related spondyloarthropathy is mainly characterised by axial involvement (including inflammatory back pain, isolated sacroiliitis and ankylosing spondylitis) but may also be associated with peripheral symptoms (i.e peripheral arthritis, dactylitis and enthesopathy, such as Achilles tendinitis, plantar fasciitis, and chest wall pain). In particular, inflammatory back pain (IBP) is characterised by an insidious onset, improves after exercise but not with rest, and is associated with morning stiffness. Up to now, several criteria sets have been proposed to define IBP. Studies conducted in various populations have confirmed a high sensitivity and specificity for the Berlin criteria. Celiac disease (CD) is an autoimmune systemic disease having among its clinical manifestations frequent symptoms common to rheumatologic diseases. Recently, it has been reported that a consistent percentage of the general population consider themselves to be suffering from problems caused by wheat and/or gluten ingestion, even though they do not have CD or wheat allergy. This clinical condition has been named Non-Celiac Gluten Sensitivity' (NCGS) or Non-celic Wheat Sensitivity (NCWS). The clinical picture of NCWS is characterized by combined gastrointestinal and extra-intestinal or systemic manifestations. Many patients affected with CD and NCWS complain of IBP-like symptoms, which generally improve, together with the other clinical manifestations of the diseases, during a gluten-free diet (GFD). Therefore, the aims of the present study are to investigate 1) the effect of a GFD in IBP patients, randomly assigned to receive standard therapy for IBP or standard therapy for IBP plus GFD, for a period of at least one year, and 2) the prevalence of IBP in CD and in NCWS patients.
Detailed description
Articular involvement is the most frequent extra-intestinal manifestation of inflammatory bowel diseases (IBD), frequently follows a course that is independent of the course of intestinal involvement, and its diagnosis mainly relies on clinical evidence and imaging data, because laboratory assessments are rarely useful. More in details, IBD-related arthropathy is one of a group of inflammatory arthritides, known as seronegative spondyloarthropathies, that also includes idiopathic ankylosing spondylitis, reactive arthritis, psoriatic arthritis, and undifferentiated seronegative spondyloarthropathies, all of which are classified on the basis of peripheral arthritis (asymmetrical, predominantly in the lower extremities) and/or inflammatory spinal involvement in IBD patients using the well-known criteria of the European Spondyloarthropathy Study Group. IBD-related spondyloarthropathy is mainly characterised by axial involvement (including inflammatory back pain, isolated sacroiliitis and ankylosing spondylitis) but may also be associated with peripheral symptoms (i.e peripheral arthritis, dactylitis and enthesopathy, such as Achilles tendinitis, plantar fasciitis, and chest wall pain). In particular, inflammatory back pain (IBP) is characterised by an insidious onset, improves after exercise but not with rest, and is associated with morning stiffness. It may also present as pain during the second half of the night and/or alternating buttock pain. Up to now, several criteria sets have been proposed to define IBP. Firstly, the Calin criteria set was developed in 1977 and has since then been most widely used for defining IBP. The Calin criteria set has no entry criteria and is not based on standardized questions. Studies conducted in various populations have confirmed a high sensitivity for the Calin criteria, but shown much lower specificity than that reported in the original study. Berlin criteria for IBP were derived from a controlled study, including patients with ankylosing spondylitis and mechanical low back pain, who all had chronic low back pain. Berlin criteria are applicable only to those patients with chronic low back pain (>3 months) and age younger than <50 years old. This criteria set yielded a sensitivity of 70% and a specificity of 81% if at least two of the four following criteria were met: morning stiffness of >30-min duration, improvement in back pain with exercise but not with rest, awakening because of back pain during the second half of the night only, and alternating buttock pain. Assessment of Spondyloarthritis International Society (ASAS) has just recently published new criteria for classification of IBP. These were based on the expert judgment of the rheumatologist as the "gold standard" for diagnosing IBP in patients with chronic back pain of unknown origin. These new candidate IBP criteria administered by the interviewing clinician included the domains "improvement with exercise," "nocturnal pain," "age at onset <40 years," and "no improvement with rest." They were then validated in a distinct cohort of patients presenting to the rheumatologist with new-onset back pain and were shown to have a sensitivity of 79.6% and specificity of 72.4%. Celiac disease (CD) is an autoimmune systemic disease having among its clinical manifestations frequent symptoms common to rheumatologic diseases, such as musculoskeletal pain, asthenia, and cognitive fatigue. Recently, it has been reported that a consistent percentage of the general population consider themselves to be suffering from problems caused by wheat and/or gluten ingestion, even though they do not have CD or wheat allergy. This clinical condition has been named Non-Celiac Gluten Sensitivity' (NCGS). In a previous paper the investigators suggested the term 'Non-Celiac Wheat Sensitivity' (NCWS), since it is not known what component of wheat causes the symptoms in NCGS patients, and the investigators also showed that these patients had a high frequency of coexistent multiple food hypersensitivity. The clinical picture of NCWS is characterized by combined gastrointestinal (bloating, abdominal pain, diarrhea and/or constipation, nausea, epigastric pain, gastroesophageal reflux, aphthous stomatitis) and extra-intestinal or systemic manifestations (headache, depression, anxiety, 'foggy mind,' tiredness, dermatitis or skin rash, fibromyalgia-like joint/muscle pain, leg or arm numbness, and anemia). NCWS lacks of specific diagnostic tests, being its diagnosis essentially of exclusion. Many patients affected with CD and NCWS complain of IBP-like symptoms, which significantly affect the patients' quality of life and generally improve, together with the other clinical manifestations of the diseases, during a gluten-free diet (GFD). Therefore, the aims of the present study are to investigate 1) the effect of a GFD in IBP patients, randomly assigned to receive standard therapy for IBP or standard therapy for IBP plus GFD, for a period of at least one year, and 2) the prevalence of IBP in CD and in NCWS patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IBP patients on standard therapy | No intervention | –IBP patients on standard therapy. |
| IBP patients on standard therapy and GFD | Active comparator | Other: Gluten free dietIBP patients on standard therapy and GFD |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gluten free dietThe investigators will evaluate the effect of a gluten free diet (GFD) in IBP patients, randomly assigned to receive standard therapy for IBP or standard therapy for IBP plus GFD, for a period of at least one year. | Other | IBP patients on standard therapy and GFD |
Primary outcome
Musculoskeletal (back pain) evaluation at baseline and after GFD
Time frame: Change from baseline at 12 months
Musculoskeletal (back pain) evaluation, from baseline at 12 months of GFD, according to the scores calculated on the basis of Visual Analogue Scales for Musculoskeletal (back pain), taking into account whether the patients adhered or not to the GFD.
Changes in cytokines production from peripheral blood mononuclear (PBMC) at baseline and after GFD
Time frame: Change from baseline at 12 months
Changes in cytokines production from peripheral blood mononuclear (PBMC), from baseline (i.e. at diagnosis) at 12 months of GFD, taking into account whether the patients adhered or not to the GFD.
1 secondary outcome
Prevalence of IBP in CD and in NCWS patients.
Time frame: up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Results publication: PubMed 25694210Mansueto P, Seidita A, D'Alcamo A, Carroccio A. Role of FODMAPs in Patients With Irritable Bowel Syndrome. Nutr Clin Pract. 2015 Oct;30(5):665-82. doi: 10.1177/0884533615569886. Epub 2015 Feb 18.
- Results publication: PubMed 25625764Carroccio A, D'Alcamo A, Mansueto P. Nonceliac wheat sensitivity in the context of multiple food hypersensitivity: new data from confocal endomicroscopy. Gastroenterology. 2015 Mar;148(3):666-7. doi: 10.1053/j.gastro.2014.11.047. Epub 2015 Jan 24. No abstract available.
- Results publication: PubMed 25430806Carroccio A, Soresi M, D'Alcamo A, Sciume C, Iacono G, Geraci G, Brusca I, Seidita A, Adragna F, Carta M, Mansueto P. Risk of low bone mineral density and low body mass index in patients with non-celiac wheat-sensitivity: a prospective observation study. BMC Med. 2014 Nov 28;12:230. doi: 10.1186/s12916-014-0230-2.
- Results publication: PubMed 24533607Mansueto P, Seidita A, D'Alcamo A, Carroccio A. Non-celiac gluten sensitivity: literature review. J Am Coll Nutr. 2014;33(1):39-54. doi: 10.1080/07315724.2014.869996.
- Results publication: PubMed 24275240Carroccio A, Rini G, Mansueto P. Non-celiac wheat sensitivity is a more appropriate label than non-celiac gluten sensitivity. Gastroenterology. 2014 Jan;146(1):320-1. doi: 10.1053/j.gastro.2013.08.061. Epub 2013 Nov 22. No abstract available.
- Results publication: PubMed 24169272Carroccio A, Mansueto P, D'Alcamo A, Iacono G. Non-celiac wheat sensitivity as an allergic condition: personal experience and narrative review. Am J Gastroenterol. 2013 Dec;108(12):1845-52; quiz 1853. doi: 10.1038/ajg.2013.353. Epub 2013 Nov 5.
- Results publication: PubMed 22825366Carroccio A, Mansueto P, Iacono G, Soresi M, D'Alcamo A, Cavataio F, Brusca I, Florena AM, Ambrosiano G, Seidita A, Pirrone G, Rini GB. Non-celiac wheat sensitivity diagnosed by double-blind placebo-controlled challenge: exploring a new clinical entity. Am J Gastroenterol. 2012 Dec;107(12):1898-906; quiz 1907. doi: 10.1038/ajg.2012.236. Epub 2012 Jul 24.
- Results publication: PubMed 23183757Carroccio A, Brusca I, Mansueto P, D'alcamo A, Barrale M, Soresi M, Seidita A, La Chiusa SM, Iacono G, Sprini D. A comparison between two different in vitro basophil activation tests for gluten- and cow's milk protein sensitivity in irritable bowel syndrome (IBS)-like patients. Clin Chem Lab Med. 2013 Jun;51(6):1257-63. doi: 10.1515/cclm-2012-0609.
- Results publication: PubMed 1930310Dougados M, van der Linden S, Juhlin R, Huitfeldt B, Amor B, Calin A, Cats A, Dijkmans B, Olivieri I, Pasero G, et al. The European Spondylarthropathy Study Group preliminary criteria for the classification of spondylarthropathy. Arthritis Rheum. 1991 Oct;34(10):1218-27. doi: 10.1002/art.1780341003.
- Results publication: PubMed 140252Calin A, Porta J, Fries JF, Schurman DJ. Clinical history as a screening test for ankylosing spondylitis. JAMA. 1977 Jun 13;237(24):2613-4.
- Results publication: PubMed 16447233Rudwaleit M, Metter A, Listing J, Sieper J, Braun J. Inflammatory back pain in ankylosing spondylitis: a reassessment of the clinical history for application as classification and diagnostic criteria. Arthritis Rheum. 2006 Feb;54(2):569-78. doi: 10.1002/art.21619.
- Results publication: PubMed 19147614Sieper J, van der Heijde D, Landewe R, Brandt J, Burgos-Vagas R, Collantes-Estevez E, Dijkmans B, Dougados M, Khan MA, Leirisalo-Repo M, van der Linden S, Maksymowych WP, Mielants H, Olivieri I, Rudwaleit M. New criteria for inflammatory back pain in patients with chronic back pain: a real patient exercise by experts from the Assessment of SpondyloArthritis international Society (ASAS). Ann Rheum Dis. 2009 Jun;68(6):784-8. doi: 10.1136/ard.2008.101501. Epub 2009 Jan 15.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Antonio Carroccio, PhD study director
University of Palermo
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gluten free diet in people with Inflammatory Back Pain, run by University of Palermo at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antonio Carroccio, PhD (+390916552884, acarroccio@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Musculoskeletal (back pain) evaluation at baseline and after GFD (time frame: Change from baseline at 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03017716, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.