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CompletedNCT07424313Updated Feb 24, 2026

The Low FODMAP Diet in Individuals With Small Intestinal Bacterial Overgrowth (SIBO)

An interventional study of Low FODMAP Diet and Healthy Eating Diet in SIBO, Small Intestinal Bacterial Overgrowth and Small Intestinal Bacterial Overgrowth Syndrome (SIBO), sponsored by Warsaw University of Life Sciences. Completed at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-24.

Sponsored by Warsaw University of Life Sciences · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years after the study started (first participant enrolled Feb 2024, registered Feb 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
51
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • SIBO
  • Small Intestinal Bacterial Overgrowth
  • Small Intestinal Bacterial Overgrowth Syndrome (SIBO)

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03

In context

Blind Loop Syndrome

11 studies on the registry are indexed under Blind Loop Syndrome; 4 are open to participants now.

This study's enrollment of 51 is close to the median of 48 across 10 interventional studies indexed under Blind Loop Syndrome.

Browse Blind Loop Syndrome studies →

Lead sponsor

Warsaw University of Life Sciences is the lead sponsor of 4 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • \< 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)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
51 participants (actual)

Study arms

  • Experimental
    Low FODMAP Diet Intervention Group

    Participants diagnosed with SIBO who followed a low FODMAP diet after completion of antibiotic therapy.

    Other: Low FODMAP Diet

  • Sham comparator
    Control Group

    Participants diagnosed with SIBO who followed a diet consistent with the principles of healthy eating after completion of antibiotic therapy.

    Other: Healthy Eating Diet

Interventions

  • OtherLow FODMAP Diet

    Following a low FODMAP diet (elimination and reintroduction phases for 4 and 8 weeks, respectively, for a total of 12 weeks)

  • OtherHealthy Eating Diet

    Applying recommendations consistent with proper nutrition principles, with particular focus on breaks between meals and the principle of mindful eating

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12 weeks

  2. 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.

    Time frame: 12 weeks

  3. 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.

    Time frame: 12 weeks

  4. Nutritional status - Blood biochemical parameters (Serum folate concentration)

    Change in serum folate levels measured in ng/mL at baseline and after the dietary intervention.

    Time frame: 12 weeks

  5. Nutritional status - Blood biochemical parameters (Iron status parameters)

    Change in serum iron concentration (µg/dL) measured at baseline and after the dietary intervention.

    Time frame: 12 weeks

  6. Nutritional status - Blood biochemical parameters (Serum albumin concentration)

    Change in serum albumin levels measured in g/L at baseline and after the dietary intervention.

    Time frame: 12 weeks

  7. Nutritional status - Anthropometric parameters (body weight)

    Change in body weight (kg) measurements at baseline and after the dietary intervention.

    Time frame: 12 weeks

  8. 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).

    Time frame: 12 weeks

  9. 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).

    Time frame: 12 weeks

Secondary outcomes

  1. 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.

    Time frame: 12 weeks

  2. 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.

    Time frame: 12 weeks

07

Study locations

1 site
  • Warsaw University of Life Sciences (WULS-SGGW)
    Warsaw, 02-776, Poland
08

References and documents

Individual participant data

Plan to share: No — The study will not share individual participant data to protect participant confidentiality and privacy.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2024 to primary completion in Sep 2025, 19 months.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 8, 2026
First posted
Feb 20, 2026
StartActual
Feb 8, 2024
Primary completionActual
Sep 18, 2025
CompletionActual
Jan 15, 2026
Last update
Feb 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07424313
Lead sponsor
Warsaw University of Life Sciences
Responsible party
dr hab. Ewa Lange, prof. SGGW (university professor, Warsaw University of Life Sciences) — Principal investigator
First posted
Feb 20, 2026
Start date
Feb 8, 2024
Primary completion
Sep 18, 2025
Completion
Jan 15, 2026
Last update
Feb 24, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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