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

Dyspepsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05750641
• Other study ID #: Functional Dyspepsia and Milk
• Status: Completed
• Start date: September 1, 2020
• Est. completion date: April 30, 2021

Study information

• Verified date: February 2023
• Source: Bezmialem Vakif University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

In this cross-sectional cohort study, 120 patients with FD diagnosed by the Rome IV criteria were included. Patients were divided equally into two groups; those who removed milk and dairy products under the advice of a dietician without medical treatment and those who did not. For determining the severity of symptoms, "The gastrointestinal Symptom Rating Scale (GSRS)" was used at the onset of the study and the end of the one-month follow-up period. Between the two groups, there was no statistically significant difference regarding age, body mass index (BMI), frequency and duration of symptoms, weight changes in the last six months, FD subtypes, and upper GI endoscopy results (p>0.05). Female patients outnumbered men in the animal milk removal group (p=0.01). Although the patients in the animal milk removal group had higher GSRS scores at the beginning (p=0.01), both groups had similar GSRS scores at the end of the study (p=0.99). After one month follow-up period, GSRS scores have improved in both groups compared to the baseline (p=0.01). However, the decrease in the GSRS total symptom score was significantly higher in the animal milk removal group compared to the free diet group (p=0.01). In the evaluation of GSRS symptom subsets, a statistically higher reduction was observed in 7 of the 15 subsets in the animal milk removal group compared to the free-diet group (p<0.05). Of the 120 FD patients who followed up for one month, 60 who removed milk products had a more significant reduction in GSRS symptom score and 7 of the 15 symptom subset scores than 60 patients receiving an unrestricted diet.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: April 30, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Digestive System Diseases
• Dyspepsia
• Gastrointestinal Diseases
• Gastrointestinal System Disease

Intervention

Other:
• removing milk and dairy products from diets without medical treatment
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
• According to current standard algorithms and guidelines, appropriate treatment for FD types.
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

Locations

Country	Name	City	State
Turkey	Bezmialem Vakif Univercity	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The comparing the scores of symptom subsets of the two patient groups	Gastrointestinal Symptom Rating Scale	one month