The Six Food Elimination in Postprandial Distress Syndrome

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The six food elimination diet, as known in eosinophilic esophagitis, will be performed in 15 patients with functional dyspepsia (subtype postprandial distress syndrome). Screening will exclude patients with allergies by performing immunocaps on blood. Before and after the 8 weeks of diet, an gastroduodenoscopy with biopsies will be performed to evaluate duodenal eosinophilia, mast cells and permeability. To evaluate gastric sensorimotor function, a gastric emptying breath test and a barostat test will be performed before and after the diet. Symptoms will be monitored with a daily diary (LPDS diary) and food intake will be evaluated during 2 weeks. If there is an improvement of symptoms during the diet, a reintroduction period will start. This period will last 6 weeks. Every 2 weeks, two food groups will be reintroduced. When there is a clear worsening in symptoms, a new endoscopy with biopsies will be performed.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Functional dyspepsia patients with meal related symptoms (Rome IV Postprandial Distress Syndrome, PDS)

• Witnessed written informed consent prior to any study procedures

• Patients aged between 18 and 70 years inclusive

• Male or female patients

• Women of child-bearing potential agree to apply a highly effective method of birth control during the entire duration of the trial. Women of non-childbearing potential may be included if surgically sterile or postmenopausal with at least 2 year without spontaneous menses.

• Subject is capable to understand the study and the questionnaires, and to comply with the study requirements.

Locations
Other Locations
Belgium
KU Leuven
RECRUITING
Leuven
Contact Information
Primary
Jolien Schol, MD
jolien.schol@kuleuven.be
16 34 56 63
Backup
Florencia Carbone, PhD
florencia.carbone@uzleuven.be
Time Frame
Start Date: 2020-02-19
Estimated Completion Date: 2025-01-31
Participants
Target number of participants: 15
Treatments
Other: Six food elimination diet
The six food elimination diet will be performed in all subjects.
Sponsors
Leads: Universitaire Ziekenhuizen KU Leuven

This content was sourced from clinicaltrials.gov