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

Status Completed

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

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

• NCT number: NCT05750641
• Study type: Observational
• Source: Bezmialem Vakif University
• Status: Completed
• Start date: September 1, 2020
• Completion date: April 30, 2021