Low-FODMAP Diet vs Standard Dietary Advice for Functional Dyspepsia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized trial compares a 4-week low-FODMAP diet plus dietitian counseling to standard dietary advice in adults with Rome IV–diagnosed functional dyspepsia and moderate-to-severe symptoms. Participants will have postprandial distress syndrome, normal endoscopy within the past 6-12 months, and negative Helicobacter pylori testing. The goal is to see if restricting certain fermentable carbohydrates can reduce upper abdominal fullness, bloating, and pain more than standard guidance. The study excludes IBS, major organic disease, eating disorders, pregnancy, recent restrictive diets, and significant comorbidity. Outcomes will focus on symptom improvement and tolerance of the dietary interventions.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adults aged 18-70 years.
* Diagnosis of functional dyspepsia according to Rome criteria.
* Normal upper gastrointestinal endoscopy within 1 year before enrollment.
* Negative Helicobacter pylori status based on urea breath test, stool antigen test, or histology.
* Postprandial distress syndrome (PDS) or PDS with overlapping epigastric pain syndrome (EPS).

Exclusion Criteria:

* Diagnosis of irritable bowel syndrome (IBS) according to the Rome IV criteria.
* Presence of organic gastrointestinal disease, including inflammatory bowel disease, peptic ulcer disease, celiac disease, or active gastrointestinal malignancy.
* Active systemic malignancy or severe systemic illness.
* Current or prior diagnosis of an eating disorder, or evidence of malnutrition.
* Adherence within the past 4 weeks to a low-FODMAP diet or another restrictive dietary pattern that may affect fermentable carbohydrate intake, including gluten-free, lactose-free, ketogenic, low-residue, Specific Carbohydrate Diet, or structured elimination diets.
* Use of antibiotics, probiotics, or medications that may significantly affect gastrointestinal motility or microbiota within 4 weeks before enrollment, unless receiving a stable dose considered acceptable by the investigator.
* Pregnancy or lactation.
* History of abdominal surgery, except appendectomy, cesarean section, or tubal resection.

Where it's running

• King chulalongkorn memorial hospital
  Bangkok, Pathumwan, Thailand Recruiting

Study contacts

• Study coordinator: Peacharin Yolrabil, Medicine
• Email: peacharin.y@gmail.com
• Phone: 66863946900

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Pain Reprocessing Therapy for Functional Dyspepsia

  A small pilot test to see if a psychological therapy that uses exposure techniques can lessen digestive symptoms and help daily functioning in people with functional dyspepsia.

  Recruiting Mayo Clinic · Rochester, Minnesota · NCT07838324

• Identifying Signatures of Gut Interoception in Functional Dyspepsia and Anorexia Nervosa

  This study tests how the gut-brain connection works in people with functional dyspepsia or anorexia nervosa using brain imaging.

  Recruiting Massachusetts General Hospital · Boston, Massachusetts · NCT07772167

• Prevalence and possible role of non-H. pylori Helicobacter species in gastric conditions and cancers

  Researchers will test stomach tissue from people with functional dyspeasia, various gastritis conditions, gastric cancer, and bariatric patients to see if non-H. pylori Helicobacter species are present.

  Recruiting at 3 sites Universiteit Antwerpen · Edegem and 2 other locations · NCT07770126

• Liver Fat and Scarring in People Suspected of Non-Celiac Wheat Sensitivity

  This study looks to see if people with non-celiac wheat sensitivity have liver fat or fibrosis and how this relates to IBS/FD and celiac disease.

  Recruiting at 2 sites University of Palermo · Palermo, Palermo and 1 other locations · NCT07750535

• Prevalence of Functional Dyspepsia in a Rural Community in Bangladesh

  This study tests how common functional dyspepsia is in a rural Bangladeshi community among adults who live there.

  Recruiting Bangladesh Medical University · Dhaka · NCT07694778

• DA-9701 in functional dyspepsia: see if it helps reduce symptoms

  This study tests whether DA-9701 (and related formulations) can help adults with functional dyspepsia feel better compared with placebo.

  Recruiting Phase 4 Dong-A ST Co., Ltd. · Seoul · NCT07686679

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.