Irritable Bowel SyndromeNCT04307368
The Impact of Dietary Treatment in Patients With Irritable Bowel Syndrome
A study testing FODMAP diet, Elimination-rotational diet and Classic diet in people with Irritable Bowel Syndrome, run by Medical University of Bialystok.
Trial summary
The obtained results are likely to determine whether changes in the diet of patients with irritable bowel syndrome will affect their nutritional status. They will also allow you to assess whether dietary treatment will affect the resolution or alleviation, or severity of disease symptoms in IBS. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- FODMAP diet, Elimination-rotational diet and Classic diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Dec 2018
- Phase
- Interventional
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with irritable bowel syndrome (mixed) according to Rome III Criteria, in whom the gastroenterologist does not find any other gastrointestinal diseases that may affect this study
- patients who understand the purpose and nature of the study, agree to its terms and give informed written consent before entering the study
- who are physically and mentally able to participate in the study and express their will to cooperate
Who cannot join
- patients who use strong opioid and psychotropic drugs: barbiturates
- patients who take part in another clinical trial related to the treatment of gastrointestinal diseases or dietary therapy within 90 days prior to inclusion in this study
- patients who have a pacemaker or heart defibrillator implanted and metal endoprostheses (due to the used body composition test method (BIA - Bioelectrical Impedance Analysis)
About this study
Official title: The Impact of Dietary Treatment Using a Low FODMAP Diet on the Occurrence of Selected Intestinal Bacteria and the Clinical Condition of Patients With Irritable Bowel Syndrome
The obtained results are likely to determine whether changes in the diet of patients with irritable bowel syndrome will affect their nutritional status. They will also allow you to assess whether dietary treatment will affect the resolution or alleviation, or severity of disease symptoms in IBS. The test results can be used in clinical practice.
Participation in the study does not carry any risk of complications associated with undergoing a medical experiment.
Read the detailed description
This is a randomized, parallel study that includes 1 initial visit and 1 final visit, separated by 8 weeks of diet. The investigators enrolled 73 women in the study, who met the criteria for inclusion in the study, to determine whether changes in the diet of patients with irritable bowel syndrome will affect their nutritional status. At the initial and final visit (after 8 weeks) in all patients, anthropometric measurements, body composition, an interview questionnaire concerning the symptoms of the disease was performed, the intensity of abdominal pain was assessed, the life quality of patients on the IBS-QOL scale was assessed, the calprotectin concentration in the stool was determined and the questionnaire regarding the quantitative assessment of diet was performed. The study population was divided using simple lottery into 3 groups with different dietary treatment for 8 weeks: group 1 - 26 patients - diet with low content of easily fermenting carbohydrates (FODMAP), group 2 - 21 patients - an elimination-rotation diet, and group 3 - (control) - 26 patients - classic diet treatment (recommended by the leading gastroenterologist).
- Conditions
- Irritable Bowel Syndrome
- Being tested
- FODMAP diet, Elimination-rotational diet, Classic diet
- Keywords
- irritable bowel syndrome, diet
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FODMAP dietOther
8 weeks of diet low in fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP)
Elimination-rotational dietOther
During the patient's first visit an IgG antibody titration test against specific nutrients will be performed to determine food hypersensitivity. Based on the results of the obtained food panels, patients will be offered an elimination-rotational diet for a period of 8 weeks.
Classic dietOther
8 weeks of classic diet treatment (recommended by the gastroenterologist who supervises them).
| Study group | Role | What they receive |
|---|---|---|
| FODMAP diet | Experimental | Patients with IBS. Interventions: 8 weeks of diet low in fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP) Receives: Other: FODMAP diet |
| Elimination-rotational diet | Experimental | Patients with IBS. Interventions: During the patient's first visit an IgG antibody titration test against specific nutrients will be performed to determine food hypersensitivity. Based on the results of the obtained food panels, patients will be offered an elimination-rotational diet for a period of 8 weeks. Receives: Other: Elimination-rotational diet |
| Classic diet | Experimental | Patients with IBS. Interventions: 8 weeks of classic diet treatment (recommended by the gastroenterologist who supervises them). Receives: Other: Classic diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparative analysis of selected clinical symptoms of IBS patients before and after 8 weeks of nutritional intervention.
During the first visit, each applicant will receive a detailed interview on sociodemographic characteristics, lifestyle and professional work. The interview questionnaire contains questions about the most common symptoms of the disease (including abdominal pain, flatulence, stool disorders).
Measured: 8 weeks
Assessment of intestinal inflammation in patients with irritable bowel syndrome (before and after 8 weeks of using the recommended diet).
Intestinal inflammation was assessed by faecal calprotectin. At the first visit, each patient must bring a stool sample to assess calprotectin levels. The test will be carried out normalized and certified by Elisa.
Measured: 8 weeks
Comparative analysis of the quality of life of IBS patients before and after 8 weeks of nutritional intervention.
The current quality of life for patients with irritable bowel syndrome will be assessed using the IBS-QOL (Irritable Bowel Syndrome-Quality Of Life Questionnaire); total score between 34 -170 points, the highest sum means the most reduced quality of life.
Measured: 8 weeks
Comparative analysis of the nutritional value of diets used before the study and after 8 weeks of dietary treatment using the FODMAP diet, elimination-rotation and conventional.
Quantitative diet assessment was based on a 24h diet recall from 3 days preceding the study. The respondents estimated the amount of each food and ingredient consumed. The results from each patient were averaged in accordance with the adopted recommendations of the Institute of Food and Nutrition in Warsaw and the nutritional value of daily food rations was analyzed using Dieta 5.0 software calculating the average intake of the energy, nutrients, vitamins, minerals, cholesterol and dietary fibre.
Measured: 8 weeks
Individually calculated Body Mass Index
Individually calculated BMI (Body Mass Index) - this is the ratio obtained by dividing the body weight in kilograms by the square of the height in meters
Measured: 8 weeks
Individually calculated Waist-Hip Ratio
Individually calculated WHR (Waist-Hip Ratio) - coefficient resulting from dividing the waist circumference by the hip circumference (measurements made in centimeters).
Measured: 8 weeks
Assessment of nutrients causing food hypersensitivity (IgG1-3)
The baseline reaction of alimentary IgG1-3 in blood serum was measured in μg/ml in the ranges: <7.5 μg/ml - not elevated, ≥7.5 μg/ml - increased and ≥20.0 μg/ml - significantly increased.
Measured: 8 weeks
Assessment of body composition
Assessment of body composition of subjects tested using the bioelectroimpedance method (MALTRON BioScan 920-2 by Maltron International LTD).
Measured: 8 weeks
Pain intesity
Pain intensity will be assessed using the VAS (Visual Analogue Scale) numerical scale; total score between 0 -10 points, the higher the value the stronger the pain.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study startApr 2016
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Bialystok
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diana Wasiluk, Medical University of Bialystok
- Investigators
- Diana Wasiluk, MS, PhD, Principal investigator, Medical University of Bialystok
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04307368
- Sponsor's protocol ID
- R-I-002/389/2015
- Status last verified
- Mar 2020
- First submitted
- 25 Feb 2020
- Last updated
- 13 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Dietary Treatment Using a Low FODMAP Diet on the Occurrence of Selected Intestinal Bacteria and the Clinical Condition of Patients With Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT04307368
- Acronym / sponsor ID
- R-I-002/389/2015
- Conditions
- Irritable Bowel Syndrome
- Keywords
- irritable bowel syndrome, diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Medical University of BialystokUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 13 Mar 2020 (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 obtained results are likely to determine whether changes in the diet of patients with irritable bowel syndrome will affect their nutritional status. They will also allow you to assess whether dietary treatment will affect the resolution or alleviation, or severity of disease symptoms in IBS. The test results can be used in clinical practice.
Participation in the study does not carry any risk of complications associated with undergoing a medical experiment.
Detailed description
This is a randomized, parallel study that includes 1 initial visit and 1 final visit, separated by 8 weeks of diet. The investigators enrolled 73 women in the study, who met the criteria for inclusion in the study, to determine whether changes in the diet of patients with irritable bowel syndrome will affect their nutritional status. At the initial and final visit (after 8 weeks) in all patients, anthropometric measurements, body composition, an interview questionnaire concerning the symptoms of the disease was performed, the intensity of abdominal pain was assessed, the life quality of patients on the IBS-QOL scale was assessed, the calprotectin concentration in the stool was determined and the questionnaire regarding the quantitative assessment of diet was performed. The study population was divided using simple lottery into 3 groups with different dietary treatment for 8 weeks: group 1 - 26 patients - diet with low content of easily fermenting carbohydrates (FODMAP), group 2 - 21 patients - an elimination-rotation diet, and group 3 - (control) - 26 patients - classic diet treatment (recommended by the leading gastroenterologist).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| FODMAP diet | Experimental | Other: FODMAP dietPatients with IBS. Interventions: 8 weeks of diet low in fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP) |
| Elimination-rotational diet | Experimental | Other: Elimination-rotational dietPatients with IBS. Interventions: During the patient's first visit an IgG antibody titration test against specific nutrients will be performed to determine food hypersensitivity. Based on the results of the obtained food panels, patients will be offered an elimination-rotational diet for a period of 8 weeks. |
| Classic diet | Experimental | Other: Classic dietPatients with IBS. Interventions: 8 weeks of classic diet treatment (recommended by the gastroenterologist who supervises them). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients with irritable bowel syndrome (mixed) according to Rome III Criteria, in whom the gastroenterologist does not find any other gastrointestinal diseases that may affect this study
- patients who understand the purpose and nature of the study, agree to its terms and give informed written consent before entering the study
- who are physically and mentally able to participate in the study and express their will to cooperate
Key exclusion criteria (3 listed)
- patients who use strong opioid and psychotropic drugs: barbiturates
- patients who take part in another clinical trial related to the treatment of gastrointestinal diseases or dietary therapy within 90 days prior to inclusion in this study
- patients who have a pacemaker or heart defibrillator implanted and metal endoprostheses (due to the used body composition test method (BIA - Bioelectrical Impedance Analysis)
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 |
|---|---|---|
| FODMAP diet8 weeks of diet low in fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP) | Other | FODMAP diet |
| Elimination-rotational dietDuring the patient's first visit an IgG antibody titration test against specific nutrients will be performed to determine food hypersensitivity. Based on the results of the obtained food panels, patients will be offered an elimination-rotational diet for a period of 8 weeks. | Other | Elimination-rotational diet |
| Classic diet8 weeks of classic diet treatment (recommended by the gastroenterologist who supervises them). | Other | Classic diet |
Primary outcome
Comparative analysis of selected clinical symptoms of IBS patients before and after 8 weeks of nutritional intervention.
Time frame: 8 weeks
During the first visit, each applicant will receive a detailed interview on sociodemographic characteristics, lifestyle and professional work. The interview questionnaire contains questions about the most common symptoms of the disease (including abdominal pain, flatulence, stool disorders).
Assessment of intestinal inflammation in patients with irritable bowel syndrome (before and after 8 weeks of using the recommended diet).
Time frame: 8 weeks
Intestinal inflammation was assessed by faecal calprotectin. At the first visit, each patient must bring a stool sample to assess calprotectin levels. The test will be carried out normalized and certified by Elisa.
Comparative analysis of the quality of life of IBS patients before and after 8 weeks of nutritional intervention.
Time frame: 8 weeks
The current quality of life for patients with irritable bowel syndrome will be assessed using the IBS-QOL (Irritable Bowel Syndrome-Quality Of Life Questionnaire); total score between 34 -170 points, the highest sum means the most reduced quality of life.
Comparative analysis of the nutritional value of diets used before the study and after 8 weeks of dietary treatment using the FODMAP diet, elimination-rotation and conventional.
Time frame: 8 weeks
Quantitative diet assessment was based on a 24h diet recall from 3 days preceding the study. The respondents estimated the amount of each food and ingredient consumed. The results from each patient were averaged in accordance with the adopted recommendations of the Institute of Food and Nutrition in Warsaw and the nutritional value of daily food rations was analyzed using Dieta 5.0 software calculating the average intake of the energy, nutrients, vitamins, minerals, cholesterol and dietary fibre.
Individually calculated Body Mass Index
Time frame: 8 weeks
Individually calculated BMI (Body Mass Index) - this is the ratio obtained by dividing the body weight in kilograms by the square of the height in meters
Individually calculated Waist-Hip Ratio
Time frame: 8 weeks
Individually calculated WHR (Waist-Hip Ratio) - coefficient resulting from dividing the waist circumference by the hip circumference (measurements made in centimeters).
Assessment of nutrients causing food hypersensitivity (IgG1-3)
Time frame: 8 weeks
The baseline reaction of alimentary IgG1-3 in blood serum was measured in μg/ml in the ranges: <7.5 μg/ml - not elevated, ≥7.5 μg/ml - increased and ≥20.0 μg/ml - significantly increased.
Assessment of body composition
Time frame: 8 weeks
Assessment of body composition of subjects tested using the bioelectroimpedance method (MALTRON BioScan 920-2 by Maltron International LTD).
Pain intesity
Time frame: 8 weeks
Pain intensity will be assessed using the VAS (Visual Analogue Scale) numerical scale; total score between 0 -10 points, the higher the value the stronger the pain.
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 13 Mar 2020.
- Individual participant dataSharing planned: No
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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.
Diana Wasiluk, MS, PhD principal investigator
Medical University of Bialystok
Questions about this trial
What is this clinical trial studying?
A study testing FODMAP diet, Elimination-rotational diet and Classic diet in people with Irritable Bowel Syndrome, run by Medical University of Bialystok.
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 3 inclusion and 3 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 13 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Comparative analysis of selected clinical symptoms of IBS patients before and after 8 weeks of nutritional intervention. (time frame: 8 weeks). The study lists 9 primary outcomes in all. 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 13 Mar 2020.