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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low FODMAP Diet Intervention Group | Experimental | Participants diagnosed with SIBO who followed a low FODMAP diet after completion of antibiotic therapy. |
|
| Control Group | Sham Comparator | Participants diagnosed with SIBO who followed a diet consistent with the principles of healthy eating after completion of antibiotic therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Warsaw University of Life Sciences (WULS-SGGW) | Warsaw | 02-776 | Poland |
The study will not share individual participant data to protect participant confidentiality and privacy.
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| ID | Term |
|---|---|
| D000092622 | FODMAP Diet |
| D000072001 | Diet, Healthy |
| ID | Term |
|---|---|
| D000092724 | Elimination Diets |
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
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| Healthy Eating Diet | Other | Applying recommendations consistent with proper nutrition principles, with particular focus on breaks between meals and the principle of mindful eating |
|
| 12 weeks |
| Nutritional status - Anthropometric parameters (body weight) | Change in body weight (kg) measurements at baseline and after the dietary intervention. | 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). | 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). | 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. | 12 weeks |
| D010829 | Physiological Phenomena |