Assessment of the Impact of the Low FODMAP Diet on Gastrointestinal Symptoms and Nutritional Status in People With Small Intestinal Bacterial Overgrowth (SIBO)
| Registry | NCT07424313 |
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| Status | Completed |
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| Phase | Not applicable |
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| Study type | Interventional; randomized, parallel, masking: single, treatment |
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| Enrollment | 51 (Actual) |
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| Sponsor | Warsaw University of Life Sciences (Other) |
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| Conditions | SIBO, Small Intestinal Bacterial Overgrowth, Small Intestinal Bacterial Overgrowth Syndrome (SIBO) |
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| Interventions | Low FODMAP Diet, Healthy Eating Diet (Other) |
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| Dates | start 2024-02-08, primary completion 2025-09-18, completion 2026-01-15, first posted 2026-02-20, last updated 2026-02-24 |
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| Locations | 1 site in Poland |
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Related Papers Related Patents Related Grants Related Experts
All trials for SIBO All trials for Small Intestinal Bacterial Overgrowth All trials of Low FODMAP Diet All trials of Healthy Eating Diet
-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). 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.
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+Arms and interventions
| Arm | Type | Interventions | Description |
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| Low FODMAP Diet Intervention Group | Experimental | Other: Low FODMAP Diet | Participants diagnosed with SIBO who followed a low FODMAP diet after completion of antibiotic therapy. |
| Control Group | Sham comparator | Other: Healthy Eating Diet | Participants diagnosed with SIBO who followed a diet consistent with the principles of healthy eating after completion of antibiotic therapy. |
- Low FODMAP Diet (Other): Following a low FODMAP diet (elimination and reintroduction phases for 4 and 8 weeks, respectively, for a total of 12 weeks)
- Healthy Eating Diet (Other): Applying recommendations consistent with proper nutrition principles, with particular focus on breaks between meals and the principle of mindful eating
+Outcome measures
Primary outcomes
- Gastrointestinal Adverse Symptoms Assessment Questionnaire (GASAQ) total score [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) [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) [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) [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) [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) [12 weeks]: Change in serum albumin levels measured in g/L at baseline and after the dietary intervention.
- Nutritional status - Anthropometric parameters (body weight) [12 weeks]: Change in body weight (kg) measurements at baseline and after the dietary intervention.
- Nutritional status - Anthropometric parameters (body mass index (BMI) [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) [12 weeks]: Change in body fat percentage (%) at baseline and after the dietary intervention. Body fat percentage measured using bioelectrical impedance analysis (ACCUNIQ BC720).
Secondary outcomes
- Quality of life - IBS-specific (Irritable Bowel Syndrome-Quality of Life (IBS-QOL) total score) [12 weeks]: 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.
- Quality of Life - General (Short Form-36 Health Survey (SF-36) total score) [12 weeks]: 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.
+Eligibility
Sex: All, ages: 18 Years to any
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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,
* 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)
+Locations (1)
| Facility | City | Country | Status |
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| Warsaw University of Life Sciences (WULS-SGGW) | Warsaw | Poland | |