Effect of a Low FODMAP Diet in IBS and Functional Constipation with Bloating: a Randomized Double-Blind Trial

Launched by MAHIDOL UNIVERSITY · Mar 6, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a low FODMAP diet on individuals with Irritable Bowel Syndrome (IBS) and Functional Constipation (FC) who experience bloating. FODMAPs are types of carbohydrates that can be hard for some people to digest, which may lead to uncomfortable symptoms like bloating. In this study, eligible participants will be randomly assigned to follow either a low or high FODMAP diet for two weeks. The main goal is to see if following the low FODMAP diet can significantly reduce bloating and improve overall gut health.

To participate, individuals must be at least 18 years old and have a diagnosis of IBS or FC with persistent bloating that affects their daily life. They should have stable bowel habits and be able to follow the dietary guidelines of the study. Participants can expect to eat standardized meals, and their bloating severity will be measured throughout the trial. This research aims to better understand how diet influences gut health and may help many people manage their symptoms more effectively.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥18 years
• • Diagnosed with Irritable Bowel Syndrome (IBS) or Functional Constipation (FC) based on Rome IV criteria
• • Persistent bloating affecting daily life, with a bloating VAS score ≥4
• • Stable bowel habits with Bristol Stool Form Scale (BSFS) type 3-5
• • History of prior treatment with antispasmodics and/or prokinetics (allowed if dose remains stable)
• • Able to comply with dietary intervention and study procedures
• Exclusion Criteria:
• • Prior gastrointestinal surgery (except appendectomy or cholecystectomy)
• • Use of antibiotics, proton pump inhibitors (PPIs), probiotics, NSAIDs, lactulose, or metformin within the past 4 weeks
• • Presence of systemic diseases affecting gut microbiota (e.g., liver cirrhosis, uncontrolled diabetes, end-stage renal disease, obesity, cancer, psychiatric disorders)
• • Inability to consume study meals or follow dietary restrictions