Actively Recruiting
The Six Food Elimination in Postprandial Distress Syndrome
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2024-07-03
15
Participants Needed
1
Research Sites
258 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Six Food Elimination in Postprandial Distress Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Functional dyspepsia patients with meal related symptoms (Rome IV Postprandial Distress Syndrome, PDS)
- Written informed consent before any study procedures
- Aged between 18 and 70 years inclusive
- Male or female patients
- Women of child-bearing potential must use highly effective birth control during the trial
- Women not of childbearing potential must be surgically sterile or postmenopausal for at least 2 years
- Able to understand the study and comply with study requirements
You will not qualify if you...
- History of gastrointestinal surgery other than appendectomy
- Organic gastro-intestinal disease
- Major psychiatric disorder
- Patients with eosinophilic esophagitis
- Presence of diabetes mellitus
- Presence of coeliac disease, lupus, scleroderma or other systemic autoimmune diseases
- Active Helicobacter pylori infection or less than 6 months after eradication
- Predominant irritable bowel syndrome (IBS)
- Predominant gastro-oesophageal reflux disease (GERD)
- Atopic constitution or food allergy
- Ongoing diet that interferes with the six food elimination diet
- Use of drugs altering gastric emptying or anti-inflammatory drugs
- Females who are pregnant or lactating
- Unable to understand or comply with the study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
KU Leuven
Leuven, Belgium, 3000
Actively Recruiting
Research Team
J
Jolien Schol, MD
CONTACT
F
Florencia Carbone, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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