DyspepsiaNCT05750641
The Efficacy of Removal of Animal Milk From the Diet in Functional Dyspepsia: A Cross-sectional Study
An observational study of Dyspepsia and Gastrointestinal System Disease, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dyspepsia, Gastrointestinal System Disease
- What is being tested?
- removing milk and dairy products from diets without medical treatment and According to current standard algorithms and guidelines, appropriate treatment for FD types.
- How many people
- 15 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2020to 30 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Dyspepsia, Gastrointestinal System Disease
- Being tested
- removing milk and dairy products from diets without medical treatment, According to current standard algorithms and guidelines, appropriate treatment for FD types.
- Keywords
- functional dyspepsia, milk, dairy products
- Medical subject headings
- Dyspepsia, Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
removing milk and dairy products from diets without medical treatmentOther
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.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
| Study group | Role | What they receive |
|---|---|---|
| diet group | those who removed milk and dairy products under the advice of a dietician without medical treatment. Receives: 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. Receives: Other: According to current standard algorithms and guidelines, appropriate treatment for FD types. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The comparing the scores of symptom subsets of the two patient groups
Gastrointestinal Symptom Rating Scale
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start1 Sep 2020
- Primary completion31 Mar 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspepsiaStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05750641
- Sponsor's protocol ID
- Functional Dyspepsia and Milk
- Status last verified
- Feb 2023
- First submitted
- 20 Feb 2023
- Last updated
- 2 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The transfer of individual participant data in the study to electronic media was not provided.
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Removal of Animal Milk From the Diet in Functional Dyspepsia: A Cross-sectional Study
- ClinicalTrials.gov ID
- NCT05750641
- Acronym / sponsor ID
- Functional Dyspepsia and Milk
- Conditions
- Dyspepsia, Gastrointestinal System Disease
- Keywords
- functional dyspepsia, milk, dairy products
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 2 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| diet group | – | Other: removing milk and dairy products from diets without medical treatmentthose who removed milk and dairy products under the advice of a dietician without medical treatment. |
| free-diet group | – | Other: 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| removing milk and dairy products from diets without medical treatmentA specialist dietician prepared a diet list based on providing adequate balanced nutrition and is handed over to the diet group without any medical treatment | Other | diet group |
| 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 | Other | free-diet group |
Primary outcome
The comparing the scores of symptom subsets of the two patient groups
Time frame: one month
Gastrointestinal Symptom Rating Scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
- Individual participant dataSharing planned: Undecided. The transfer of individual participant data in the study to electronic media was not provided.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dyspepsia and Gastrointestinal System Disease, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The comparing the scores of symptom subsets of the two patient groups (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2023.