Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2025-12-25 @ 12:06 AM
NCT ID:
NCT05779358
Eligibility Criteria:
Inclusion Criteria:
* Develops self-reported GI symptoms within 8 hours after a single intake of gluten-containing products, without a diagnosis of an organic GI disease;
* Following of willing to follow a gluten-free or gluten-restricting diet (based on a gluten-free dietary compliance questionnaire of Biagi et al. (only group 2, 3 and 4 will be eligible), for at least 1 week prior to study participation and willing to continue with this throughout the study;
* Asymptomatic or only mildly symptomatic (overall (GI) symptom score with VAS \< 30mm) while on the gluten-free diet;
* Willing to participate in a study in which they have to consume 4 slices of gluten-containing or gluten-free bread for breakfast and lunch during the test day;
* Willing and able to give written informed consent and to understand, participate and comply with the research project requirements.
Exclusion Criteria:
* Coeliac disease;
* Wheat allergy;
* Presence of an organic GI disease (such as inflammatory bowel disease) or other disease which may interfere with NCGS symptoms (upon judgment of the physician clinical investigator);
* Previous major abdominal surgery or radiotherapy interfering with GI function:
* Uncomplicated appendectomy, cholecystectomy and hysterectomy allowed unless within the past 6 months;
* Other surgery may be allowed based upon judgment of the physician-clinical investigator;
* Use of medication potentially influencing GI function and/or NCGS symptoms is allowed, provided that dosing has been stable for \> 6 weeks before enrolment;
* Administration of antibiotics, probiotic or prebiotic supplements, investigational drugs or participation in any scientific intervention study, which may interfere with this study (to be decided by the principle investigator), in the 14 days prior to the study
* Excessive use of alcohol (\>15 alcoholic units per week), or other drugs;
* Plan to lose weight or follow a specific diet within the study period;
* Any malignancy;
* Pregnancy or breastfeeding;
* Insufficient fluency of the Dutch (for Maastricht and Wageningen) or Englisch (for Leeds) language.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT05779358
Study Brief:
Protocol Section:
NCT05779358