The Efficacy of Removal of Animal Milk From the Diet in Functional Dyspepsia: A Cross-sectional Study

NCT05750641 | Completed DMC

• 1 other identifier: Functional Dyspepsia and Milk
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to learn about compare the effect of removing animal milk from diets on the symptoms of FD patients in describe participant population. The main question it aims to answer are:

• Can removing milk and dairy from diets be used to treat FD patients? The participants will be divided into two groups and will do the following;
• removing milk and dairy products under the advice of a dietician without medical treatment
• receiving medical treatment without restricted diet. Researchers will compare two groups to the effect of removing milk from diet on the symptoms of FD patients.

Conditions

Dyspepsia; Gastrointestinal System Disease

Keywords

functional dyspepsia; milk; dairy products

Outcome Measures

Primary Outcomes (1)

• The comparing the scores of symptom subsets of the two patient groups

  Gastrointestinal Symptom Rating Scale

  one month

Study Arms (2)

diet group

those who removed milk and dairy products under the advice of a dietician without medical treatment.

Other: removing milk and dairy products from diets without medical treatment

free-diet group

According to current standard algorithms and guidelines, appropriate treatment for FD types was arranged for the patient group who preferred to receive a free diet.

Other: According to current standard algorithms and guidelines, appropriate treatment for FD types.

Interventions

removing milk and dairy products from diets without medical treatment OTHER

A specialist dietician prepared a diet list based on providing adequate balanced nutrition and is handed over to the diet group without any medical treatment

diet group

According to current standard algorithms and guidelines, appropriate treatment for FD types. OTHER

According to current standard algorithms and guidelines, appropriate treatment for FD types was arranged for the patient group who preferred to receive a free diet

free-diet group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients between the ages of 18-65 admitted to the gastroenterology outpatient clinic between September 2020 and March 2021, fulfilling the Rome IV Consensus criteria for the diagnosis of FD, were included in the study in a cross-sectional and prospective manner according to the order of admission

You may qualify if:

• between the ages of 18-65
• having at least one of the complaints of postprandial fullness, early satiety, epigastric burning and pain
• the onset of the complaint is at least 6 months ago and at least one complaint has been going on at least 3 days a week for the last 3 months
• no underlying organic pathology is detected in the examinations.

You may not qualify if:

• being outside the age range of 18-65
• having alarm symptoms such as vomiting, gastrointestinal bleeding, and weight loss of 5% or more in the last 3 months
• presence of comorbidities such as dementia, CVD, psychiatric diseases
• covid-19 positivity during the research

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakif Univercity

Istanbul, 34093, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dyspepsia; Digestive System Diseases

Interventions

Guidelines as Topic

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2023
• First Posted: March 2, 2023
• Study Start: September 1, 2020
• Primary Completion: March 31, 2021
• Study Completion: April 30, 2021
• Last Updated: March 2, 2023

Record last verified: 2023-02

Locations

TU (1)