NCT06871748

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

Effect of a Low FODMAP Diet in Irritable Bowel Syndrome and Functional Constipation with Bloating: a Randomized Double-Blind Controlled Trial with Microbiota, Intestinal Gas, and Metabolomic Analysis

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: Mahidol University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical study aims to evaluate the effects of a low FODMAP diet compared to a high FODMAP diet in patients with Irritable Bowel Syndrome (IBS) and Functional Constipation (FC) with predominant bloating. The study is a randomized, double-blind, controlled trial designed to assess whether a diet low in fermentable carbohydrates can improve bloating symptoms, gut microbiota composition, intestinal gas production, and metabolic outputs. Patients meeting the Rome IV criteria for IBS or FC with persistent bloating will be enrolled and randomly assigned to receive either a low or high FODMAP diet for two weeks. Meals will be standardized to control FODMAPs composition, ensuring that FODMAP content is the primary variable. The primary endpoint is the proportion of participants with a ≥30% reduction in bloating severity, measured using the Visual Analog Scale (VAS). Secondary outcomes include changes in global IBS symptoms, abdominal pain, bowel movements, stool consistency, microbiota diversity, hydrogen/methane gas production, and metabolomic profiles. This study will contribute to the growing body of evidence supporting dietary management in disorders of gut-brain interaction (DGBI), particularly in bloating-predominant IBS and FC, and will provide insights into the mechanisms linking diet, gut microbiota, and symptom improvement.

Detailed description

Irritable Bowel Syndrome (IBS) and Functional Constipation (FC) are chronic Disorders of Gut-Brain Interaction (DGBI) characterized by altered motility, visceral hypersensitivity, dysbiosis, and central nervous system processing abnormalities. Bloating is a challenging and distressing symptom that often persists despite standard pharmacological treatments. The low FODMAP diet has been widely studied as a dietary approach to alleviate IBS symptoms. FODMAPs (Fermentable Oligosaccharides, Disaccharides, Monosaccharides, and Polyols) are poorly absorbed short-chain carbohydrates that increase osmolarity, promote intestinal gas production, and alter gut microbiota, leading to bloating and discomfort. Although studies support the effectiveness of the low FODMAP diet, existing research lacks controlled, blinded trials assessing its impact on bloating-specific symptoms and related physiological markers. This study addresses these gaps by using a double-blind, controlled design with rigorously standardized meals containing well-defined FODMAP content. It will assess clinical outcomes, gut microbiota composition, gas production, and metabolomic changes to elucidate the mechanisms underlying the diet's effects. Study Design This is a randomized, double-blind, controlled trial conducted at a single center. Participants will be assigned to receive either a low FODMAP or a high FODMAP diet for two weeks. Participants: Adults ≥18 years diagnosed with IBS or FC with persistent bloating based on Rome IV criteria. Intervention: Standardized meal plans containing either low FODMAP or high FODMAP content. Randomization: Computer-generated block randomization (block of 4) Blinding: Investigators, study staff, and participants will remain blinded to the dietary allocation. Primary Outcome: ≥30% reduction in bloating severity on the VAS scale. Secondary Outcomes: Changes in global IBS symptoms (IBS-SSS) or constipation symptoms (PAC-Sym) Abdominal pain (VAS) stool frequency, and consistency (Bristol Stool Form Scale). Gut microbiota diversity and composition (16S rRNA sequencing). Intestinal gas production (hydrogen/methane breath test). Metabolomic analysis (short-chain fatty acids, urine histamine, azelaic acid). Use of rescue medications for symptom relief. Study Procedures Baseline Assessment: Demographic data, medical history, and dietary habits (7-day food diary). Baseline bloating severity, stool consistency, and quality of life (IBS-QoL, PAC-QoL). Microbiota, breath test, and metabolomic sampling. Intervention Phase (2 Weeks): Participants consume standardized low or high FODMAP meals (3 main meals + 1 snack/day). Daily recording of symptoms, bowel movements, and use of rescue medications. Follow-up Assessments: Week 1: Phone follow-up to assess adherence and symptom progression. Week 2: Final clinical and laboratory assessments (identical to baseline). Data collection for statistical analysis comparing treatment effects. Statistical Analysis Primary endpoint (bloating reduction) analyzed using Chi-square/Fisher's exact test. Secondary outcomes analyzed with paired t-tests, Mann-Whitney U tests, and logistic regression. Microbiota diversity assessed using Shannon index, beta diversity, and PERMANOVA testing. Significance and Impact This study will provide high-quality evidence on the effectiveness of the low FODMAP diet for bloating-predominant IBS and FC, addressing critical knowledge gaps. By integrating clinical, microbiota, and metabolomic data, it will enhance understanding of diet-microbiota interactions and their role in symptom modulation.

Conditions

• Irritable Bowel Syndrome (IBS)
• Constipation - Functional
• Bloating

Interventions

Type	Name	Description
OTHER	Low FODMAP Diet	A standardized diet containing low levels of fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPs), designed to reduce bloating and gastrointestinal symptoms. Meals are pre-prepared, calorie-matched, and visually identical to those in the high FODMAP group to maintain blinding. Participants will consume three main meals and one snack daily for two weeks, with adherence monitored through food diaries and photos.
OTHER	High FODMAP Diet	A standardized diet containing high levels of fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPs) to assess its impact on bloating and gastrointestinal symptoms. Meals are calorie-matched and visually identical to those in the low FODMAP group to maintain blinding. Participants will consume three main meals and one snack daily for two weeks, with adherence tracked through food diaries and photos.

Timeline

• Start date: 2025-03-15
• Primary completion: 2026-03-15
• Completion: 2026-07-31
• First posted: 2025-03-12
• Last updated: 2025-03-12