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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.
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.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
Bezmialem Vakif Univercity
Istanbul, Turkey (Türkiye)
Start Date
September 1, 2020
Primary Completion Date
March 31, 2021
Completion Date
April 30, 2021
Last Updated
March 2, 2023
15
ACTUAL participants
removing milk and dairy products from diets without medical treatment
OTHER
According to current standard algorithms and guidelines, appropriate treatment for FD types.
OTHER
Lead Sponsor
Bezmialem Vakif University
NCT07182890
NCT07261228
Data Source & Attribution
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