CompletedNot Applicable

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

Poland51 participantsStarted 2024-02-08

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Gastrointestinal Adverse Symptoms Assessment Questionnaire (GASAQ) total score

Timeframe: 12 weeks

Nutritional status - Mini Nutritional Assessment (MNA)

Timeframe: 12 weeks

Nutritional status - Blood biochemical parameters (Serum vitamin D concentration)

Timeframe: 12 weeks

Nutritional status - Blood biochemical parameters (Serum folate concentration)

Timeframe: 12 weeks

Nutritional status - Blood biochemical parameters (Iron status parameters)

Timeframe: 12 weeks

Nutritional status - Blood biochemical parameters (Serum albumin concentration)

Timeframe: 12 weeks

Nutritional status - Anthropometric parameters (body weight)

Timeframe: 12 weeks

Trial details

NCT IDNCT07424313

SponsorWarsaw University of Life Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-18

View on ClinicalTrials.gov More SIBO trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Gastrointestinal Adverse Symptoms Assessment Questionnaire (GASAQ) total score

Timeframe: 12 weeks

Nutritional status - Mini Nutritional Assessment (MNA)

Timeframe: 12 weeks

Nutritional status - Blood biochemical parameters (Serum vitamin D concentration)

Timeframe: 12 weeks

Nutritional status - Blood biochemical parameters (Serum folate concentration)

Timeframe: 12 weeks

Nutritional status - Blood biochemical parameters (Iron status parameters)

Timeframe: 12 weeks

Nutritional status - Blood biochemical parameters (Serum albumin concentration)

Timeframe: 12 weeks

Nutritional status - Anthropometric parameters (body weight)

Timeframe: 12 weeks