NCT05651386

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2020

Completed
7 days until next milestone

Study Start

First participant enrolled

February 19, 2020

Completed
2.8 years until next milestone

First Posted

Study publicly available on registry

December 15, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2025

Completed
Last Updated

July 3, 2024

Status Verified

July 1, 2024

Enrollment Period

5 years

First QC Date

February 12, 2020

Last Update Submit

July 1, 2024

Conditions

Functional Dyspepsia

Outcome Measures

Primary Outcomes (1)

  • Duodenal eosinophilia

    Measured with duodenal biopsies with H\&E staining

    8 weeks

Secondary Outcomes (7)

  • Duodenal mast cells

    8 weeks

  • Duodenal permeability

    8 weeks

  • PDS symptoms

    8 weeks

  • Functional dyspepsia symptoms

    8 weeks

  • Symptom severity

    8 weeks

  • +2 more secondary outcomes

Study Arms (1)

Six food elimination diet

OTHER

The six food elimination diet will be performed in all subjects.

Other: Diet

Interventions

DietOTHER

No blinded, no controlled intervention.

Six food elimination diet

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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 and other systemic auto-immune disease.
  • Active H. Pylori infection or \< 6 months after eradication
  • Predominant irritable bowel syndrome (IBS)
  • Predominant gastro-oesophageal reflux disease (GERD)
  • Atopic constitution or food allergy
  • Ongoing diet which interferes with the 6 food elimination diet.
  • Drugs altering gastric emptying or anti-inflammatory drugs
  • Females who are pregnant or lactating
  • Patients not capable to understand or be compliant with the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KU Leuven

Leuven, 3000, Belgium

RECRUITING

MeSH Terms

Interventions

Diet

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Jan Tack, MD, PhD

    KU Leuven

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jolien Schol, MD

CONTACT

16 34 56 63jolien.schol@kuleuven.be

Florencia Carbone, PhD

CONTACT

florencia.carbone@uzleuven.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2020

First Posted

December 15, 2022

Study Start

February 19, 2020

Primary Completion

January 31, 2025

Study Completion

January 31, 2025

Last Updated

July 3, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)