SIBONCT07424313
The Low FODMAP Diet in Individuals With Small Intestinal Bacterial Overgrowth (SIBO)
A study testing Low FODMAP Diet and Healthy Eating Diet in people with SIBO and Small Intestinal Bacterial Overgrowth, run by Warsaw University of Life Sciences at 1 site in Poland.
Trial summary
This study aims to assess the impact of a low FODMAP diet (LFD) on gastrointestinal symptoms and nutritional status in individuals diagnosed with small intestinal bacterial overgrowth (SIBO). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SIBO, Small Intestinal Bacterial Overgrowth, Small Intestinal Bacterial Overgrowth Syndrome (SIBO)
- What is being tested?
- Low FODMAP Diet and Healthy Eating Diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 sitePoland
- Study dates
- 8 Feb 2024to 15 Jan 2026
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age > 18 years,
- SIBO diagnosed by a doctor based on a hydrogen and methane breath test,
- the use of one type of antibiotic at the same dose and for the same period of time.
Who cannot join
- BMI < 18.5 kg/m2,
- pregnancy and breastfeeding,
- the occurrence of allergies and food intolerances,
- previous operations on the digestive tract (except appendectomy and hemorrhoidectomy),
- eating disorders,
- inflammatory bowel diseases,
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- celiac disease,
- cancer, heart, liver and lung diseases with severe course, as well as neurological or psychiatric diseases,
- use of dietary modifications in the last 3 months,
- use of antibiotics other than those prescribed by a doctor to treat SIBO in the last 3 months,
- implanted stimulators (limitation of body composition measurement)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Impact of the Low FODMAP Diet on Gastrointestinal Symptoms and Nutritional Status in People With Small Intestinal Bacterial Overgrowth (SIBO)
This study aims to assess the impact of a low FODMAP diet (LFD) on gastrointestinal symptoms and nutritional status in individuals diagnosed with small intestinal bacterial overgrowth (SIBO). Participants were randomly assigned to either an intervention group or a control group following completion of antibiotic therapy. The intervention group followed a LFD, while the control group followed a normal diet, in accordance with the principles of rational nutrition. Gastrointestinal symptoms, nutritional status, and quality of life were assessed using questionnaires, dietary records, anthropometric measurements, and blood biochemical parameters.
- Conditions
- SIBO, Small Intestinal Bacterial Overgrowth, Small Intestinal Bacterial Overgrowth Syndrome (SIBO)
- Being tested
- Low FODMAP Diet, Healthy Eating Diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low FODMAP DietOther
Following a low FODMAP diet (elimination and reintroduction phases for 4 and 8 weeks, respectively, for a total of 12 weeks)
Healthy Eating DietOther
Applying recommendations consistent with proper nutrition principles, with particular focus on breaks between meals and the principle of mindful eating
| Study group | Role | What they receive |
|---|---|---|
| Low FODMAP Diet Intervention Group | Experimental | Participants diagnosed with SIBO who followed a low FODMAP diet after completion of antibiotic therapy. Receives: Other: Low FODMAP Diet |
| Control Group | Sham comparator | Participants diagnosed with SIBO who followed a diet consistent with the principles of healthy eating after completion of antibiotic therapy. Receives: Other: Healthy Eating Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal Adverse Symptoms Assessment Questionnaire (GASAQ) total score
Change in gastrointestinal symptom severity assessed using the Gastrointestinal Adverse Symptoms Assessment Questionnaire (GASAQ). The total score ranges from 0 to 100 points, with higher scores indicating more severe gastrointestinal symptoms. Assessments were performed at baseline and after the dietary intervention.
Measured: 12 weeks
Nutritional status - Mini Nutritional Assessment (MNA)
Change in nutritional status assessed using the Mini Nutritional Assessment (MNA) questionnaire. The total score ranges from 0 to 30 points, with higher scores indicating better nutritional status. Assessments were performed at baseline and after the dietary intervention.
Measured: 12 weeks
Nutritional status - Blood biochemical parameters (Serum vitamin D concentration)
Change in serum vitamin D levels measured in ng/mL at baseline and after the dietary intervention.
Measured: 12 weeks
Nutritional status - Blood biochemical parameters (Serum folate concentration)
Change in serum folate levels measured in ng/mL at baseline and after the dietary intervention.
Measured: 12 weeks
Nutritional status - Blood biochemical parameters (Iron status parameters)
Change in serum iron concentration (µg/dL) measured at baseline and after the dietary intervention.
Measured: 12 weeks
Nutritional status - Blood biochemical parameters (Serum albumin concentration)
Change in serum albumin levels measured in g/L at baseline and after the dietary intervention.
Measured: 12 weeks
Nutritional status - Anthropometric parameters (body weight)
Change in body weight (kg) measurements at baseline and after the dietary intervention.
Measured: 12 weeks
Nutritional status - Anthropometric parameters (body mass index (BMI)
Change in BMI (kg/m²) at baseline and after the dietary intervention. BMI calculated from measured body weight and height (kg/m²).
Measured: 12 weeks
Nutritional status - anthropometric parameters (body fat percentage)
Change in body fat percentage (%) at baseline and after the dietary intervention. Body fat percentage measured using bioelectrical impedance analysis (ACCUNIQ BC720).
Measured: 12 weeks
Secondary outcomes (2)
Quality of life - IBS-specific (Irritable Bowel Syndrome-Quality of Life (IBS-QOL) total score)
Change in quality of life assessed using the Irritable Bowel Syndrome-Quality of Life (IBS-QOL) questionnaire. Scores range from 0 to 100 points, with higher scores indicating better quality of life. Assessments were performed at baseline and after the dietary intervention.
Measured: 12 weeks
Quality of Life - General (Short Form-36 Health Survey (SF-36) total score)
Change in general quality of life assessed using the Short Form-36 Health Survey (SF-36), Polish version. Scores range from 0 to 100 points, with higher scores indicating better perceived health status. Assessments were performed at baseline and after the dietary intervention.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start8 Feb 2024
- Primary completion18 Sep 2025
- Study completion15 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SIBOStudies 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
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Warsaw University of Life Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dr hab. Ewa Lange, prof. SGGW, Warsaw University of Life Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07424313
- Sponsor's protocol ID
- 11/RKE/2023/U
- Status last verified
- Feb 2026
- First submitted
- 8 Feb 2026
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study will not share individual participant data to protect participant confidentiality and privacy.
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Impact of the Low FODMAP Diet on Gastrointestinal Symptoms and Nutritional Status in People With Small Intestinal Bacterial Overgrowth (SIBO)
- ClinicalTrials.gov ID
- NCT07424313
- Acronym / sponsor ID
- 11/RKE/2023/U
- Conditions
- SIBO, Small Intestinal Bacterial Overgrowth, Small Intestinal Bacterial Overgrowth Syndrome (SIBO)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Warsaw University of Life SciencesUniversity, hospital or other
- Study start
- 8 Feb 2024 (actual)
- Primary completion
- 18 Sep 2025 (actual)
- Study completion
- 15 Jan 2026 (actual)
- First posted
- 20 Feb 2026 (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.
This study aims to assess the impact of a low FODMAP diet (LFD) on gastrointestinal symptoms and nutritional status in individuals diagnosed with small intestinal bacterial overgrowth (SIBO). Participants were randomly assigned to either an intervention group or a control group following completion of antibiotic therapy. The intervention group followed a LFD, while the control group followed a normal diet, in accordance with the principles of rational nutrition. Gastrointestinal symptoms, nutritional status, and quality of life were assessed using questionnaires, dietary records, anthropometric measurements, and blood biochemical parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low FODMAP Diet Intervention Group | Experimental | Other: Low FODMAP DietParticipants diagnosed with SIBO who followed a low FODMAP diet after completion of antibiotic therapy. |
| Control Group | Sham comparator | Other: Healthy Eating DietParticipants diagnosed with SIBO who followed a diet consistent with the principles of healthy eating after completion of antibiotic therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age > 18 years,
- SIBO diagnosed by a doctor based on a hydrogen and methane breath test,
- the use of one type of antibiotic at the same dose and for the same period of time.
Key exclusion criteria (11 listed)
- BMI < 18.5 kg/m2,
- pregnancy and breastfeeding,
- the occurrence of allergies and food intolerances,
- previous operations on the digestive tract (except appendectomy and hemorrhoidectomy),
- eating disorders,
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 |
|---|---|---|
| Low FODMAP DietFollowing a low FODMAP diet (elimination and reintroduction phases for 4 and 8 weeks, respectively, for a total of 12 weeks) | Other | Low FODMAP Diet Intervention Group |
| Healthy Eating DietApplying recommendations consistent with proper nutrition principles, with particular focus on breaks between meals and the principle of mindful eating | Other | Control Group |
Primary outcome
Gastrointestinal Adverse Symptoms Assessment Questionnaire (GASAQ) total score
Time frame: 12 weeks
Change in gastrointestinal symptom severity assessed using the Gastrointestinal Adverse Symptoms Assessment Questionnaire (GASAQ). The total score ranges from 0 to 100 points, with higher scores indicating more severe gastrointestinal symptoms. Assessments were performed at baseline and after the dietary intervention.
Nutritional status - Mini Nutritional Assessment (MNA)
Time frame: 12 weeks
Change in nutritional status assessed using the Mini Nutritional Assessment (MNA) questionnaire. The total score ranges from 0 to 30 points, with higher scores indicating better nutritional status. Assessments were performed at baseline and after the dietary intervention.
Nutritional status - Blood biochemical parameters (Serum vitamin D concentration)
Time frame: 12 weeks
Change in serum vitamin D levels measured in ng/mL at baseline and after the dietary intervention.
Nutritional status - Blood biochemical parameters (Serum folate concentration)
Time frame: 12 weeks
Change in serum folate levels measured in ng/mL at baseline and after the dietary intervention.
Nutritional status - Blood biochemical parameters (Iron status parameters)
Time frame: 12 weeks
Change in serum iron concentration (µg/dL) measured at baseline and after the dietary intervention.
Nutritional status - Blood biochemical parameters (Serum albumin concentration)
Time frame: 12 weeks
Change in serum albumin levels measured in g/L at baseline and after the dietary intervention.
Nutritional status - Anthropometric parameters (body weight)
Time frame: 12 weeks
Change in body weight (kg) measurements at baseline and after the dietary intervention.
Nutritional status - Anthropometric parameters (body mass index (BMI)
Time frame: 12 weeks
Change in BMI (kg/m²) at baseline and after the dietary intervention. BMI calculated from measured body weight and height (kg/m²).
Nutritional status - anthropometric parameters (body fat percentage)
Time frame: 12 weeks
Change in body fat percentage (%) at baseline and after the dietary intervention. Body fat percentage measured using bioelectrical impedance analysis (ACCUNIQ BC720).
2 secondary outcomes
Quality of life - IBS-specific (Irritable Bowel Syndrome-Quality of Life (IBS-QOL) total score)
Time frame: 12 weeks
Quality of Life - General (Short Form-36 Health Survey (SF-36) total score)
Time frame: 12 weeks
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 24 Feb 2026.
- Individual participant dataSharing planned: No. The study will not share individual participant data to protect participant confidentiality and privacy.
Related trials for SIBO
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Prevalence of Small Intestinal Bacterial Overgrowth (SIBO) in Women With Endometriosis
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RecruitingObservational study
Characterization of Small Intestinal Bacterial Overgrowth and Intestinal Barrier-Related Biomarkers in Patients With Severe Periodontitis
Periodontitis (Stage 3), Periodontitis Stage IV
Enrolling by invitationPhase 2
Herbal Supplement (Biocidin REMOVE) for Bacterial Overgrowth in Irritable Bowel Syndrome
Irritable Bowel Syndrome (IBS), Small Intestinal Bacterial Overgrowth Syndrome (SIBO)
RecruitingObservational study
Small Intestinal Bacterial Overgrowth (SIBO) in Pancreatic Adenocarcinoma (PDAC)
Pancreatic Adenocarcinoma, Weight Loss
Active, not recruiting
The Safety And Efficacy Of A Probiotic Intervention On Lactulose Hydrogen Breath Test-Positive Patients And Related Gastrointestinal Symptoms
Small Intestinal Bacterial Overgrowth, SIBO
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?
A study testing Low FODMAP Diet and Healthy Eating Diet in people with SIBO and Small Intestinal Bacterial Overgrowth, run by Warsaw University of Life Sciences at 1 site in Poland.
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 11 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 24 Feb 2026. 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 Poland. 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. Some participants in this study may receive a placebo. 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?
Gastrointestinal Adverse Symptoms Assessment Questionnaire (GASAQ) total score (time frame: 12 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 24 Feb 2026.