An observational study in Dyspepsia and Gastrointestinal System Disease, sponsored by Bezmialem Vakif University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-03-02.
Sponsored by Bezmialem Vakif University · Observational
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:
The participants will be divided into two groups and will do the following;
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.
613 studies on the registry are indexed under Digestive System Diseases; 117 are open to participants now.
This study's enrollment of 15 is below the median of 272 across 193 observational studies indexed under Digestive System Diseases.
Browse Digestive System Diseases studies →Bezmialem Vakif University is the lead sponsor of 345 studies on the registry; 58 are open to participants now.
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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
Exclusion Criteria:
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
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.
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 was arranged for the patient group who preferred to receive a free diet
The comparing the scores of symptom subsets of the two patient groups
Gastrointestinal Symptom Rating Scale
Time frame: one month
Plan to share: Undecided — The transfer of individual participant data in the study to electronic media was not provided.
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Bezmialem Vakif University