Irritable Bowel Syndrome and the Identification of Wheat or Gluten Sensitivity (IBS-NCGS)
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|ClinicalTrials.gov Identifier: NCT04017585|
Recruitment Status : Recruiting
First Posted : July 12, 2019
Last Update Posted : July 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Non-celiac Gluten Sensitivity Irritable Bowel Syndrome||Dietary Supplement: diet containing gluten Dietary Supplement: Placebo||Not Applicable|
For this study, patients with diagnosis of IBS performed by Rome IV criteria and followed as outpatients at the Clinical Nutrition Clinic of "Petrucciani" Nursing Home of Lecce (LE), Italy, will be enrolled.
At baseline, the enrolled subjects will follow a balanced normal-caloric low-FODMAP and gluten-free diet for a period of 30 days. At the end of the 30 days patients who did not experience an improvement in symptoms will be considered "non-responders" and discontinue the clinical trial. Only those subjects who had showed a significant improvement in symptoms, will be enrolled for the phase 2 of the study that includes a challenge with gluten or with placebo, as described by the Salerno criteria.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Interventional study|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Double Blind Randomized Clinical Trial in Subjects With Irritable Bowel Syndrome for the Identification of Wheat or Gluten Sensitivity|
|Actual Study Start Date :||April 8, 2019|
|Estimated Primary Completion Date :||September 30, 2019|
|Estimated Study Completion Date :||October 30, 2019|
Active Comparator: patients with IBS treated with gluten
patients receiving flour with gluten (nocebo)
Dietary Supplement: diet containing gluten
gluten-free flour (placebo) will be added for 5 days to the low FODMAP diet. After 1 week of wash-out, patients will switch to flour with gluten (nocebo) for another 5 days
Other Name: gluten-free diet
Placebo Comparator: patients with IBS treated with placebo
patients receiving gluten-free flour (placebo)
Dietary Supplement: Placebo
- Identification of FODMAP intollerance in IBS subjects [ Time Frame: 1 months ]To evaluate the FODMAP intolerance, the response to a low FODMAP diet will be assessed by a visual analogue scale (VAS) before and after the dietary challenge. The VAS scale consists in is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (symptoms, pain, subjective feeling of well-being/malaise) orientated from the left (worst) to the right (best) The patient is invited to indicate a position (a point) along the line.
- Identification of NCGS in IBS subjects who responded to low FODMAPs diet [ Time Frame: 17 days ]To evaluate the NCGS, the response to the gluten challenge will be assessed by a visual analogue scale (VAS) before and after the dietary challenge. The VAS scale consists in is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (symptoms, pain, subjective feeling of well-being/malaise) orientated from the left (worst) to the right (best) The patient is invited to indicate a position (a point) along the line.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04017585
|Contact: Michele Barone, Prof||3477157666 ext firstname.lastname@example.org|
|Bari, BA, Italy, 70124|
|Contact: Michele Barone 3477157666 email@example.com|
|Study Director:||Michele Barone||University of Bari|