Rome IV Criteria for Functional Gastrointestinal Disorders
Overview of Rome IV Framework
The Rome IV criteria represent the current gold standard for diagnosing disorders of gut-brain interaction (formerly called functional gastrointestinal disorders), with specific diagnostic thresholds for symptom frequency, severity, and duration that differ from prior iterations. 1
The Rome IV system fundamentally shifted terminology from "functional gastrointestinal disorders" to "disorders of gut-brain interaction" (DGBI), recognizing the complex interplay of biological, psychological, and social factors in these conditions. 2, 1
Key Diagnostic Criteria by Disorder
Irritable Bowel Syndrome (IBS)
For IBS diagnosis, the Rome IV criteria require recurrent abdominal pain at least 1 day per week in the last 3 months, with symptom onset at least 6 months before diagnosis, associated with two or more of: pain related to defecation, change in stool frequency, or change in stool form. 3, 4
Critical changes from Rome III include:
- Elimination of "discomfort" as a diagnostic criterion - only pain qualifies, as discomfort is non-specific and has different meanings across languages 1, 5
- Increased frequency requirement from 3 days per month (Rome III) to at least 1 day per week 3, 6
- Pain relationship to bowel movements expanded - pain can now worsen with defecation, not just improve 1
Important caveat: These more restrictive Rome IV criteria result in approximately 50% of patients who met Rome III criteria no longer qualifying for IBS diagnosis, being reclassified as other functional bowel disorders. 3 The global prevalence dropped from 10.1% using Rome III to 4.1% using Rome IV. 3
Recent validation data suggests relaxing the pain frequency requirement back to 3 days per month (while keeping all other Rome IV criteria) improves diagnostic performance without losing specificity - this modification achieved 90.2% sensitivity and 85.1% specificity with a positive likelihood ratio of 6.06. 6
Functional Dyspepsia (FD)
Functional dyspepsia requires one or more bothersome symptoms (epigastric pain, epigastric burning, postprandial fullness, or early satiation) present for the last 3 months, with symptom onset at least 6 months before diagnosis, and no structural disease on upper endoscopy to explain symptoms. 7, 8
The term "bothersome" specifically means symptoms severe enough to interfere with daily activities. 7
FD Subtypes:
Epigastric Pain Syndrome (EPS):
- Requires bothersome epigastric pain or burning at least 1 day per week 7, 8
- Pain may occur with meals, be relieved by meals, or occur while fasting 7
- Can coexist with postprandial bloating, belching, and nausea 7
Postprandial Distress Syndrome (PDS):
- Requires bothersome postprandial fullness or early satiation at least 3 days per week 7, 8
- Symptoms are meal-triggered 7
Critical limitation for clinical practice: The Rome Foundation acknowledges that requiring symptoms for 3 months with onset 6 months prior is too restrictive for routine care and potentially delays diagnosis and treatment. 7 They developed less restrictive "clinical criteria" requiring only 8 weeks of cardinal symptoms for practical use. 7
Approximately 80% of patients with dyspepsia symptoms will have functional dyspepsia after endoscopy excludes structural disease. 8 Patients commonly have overlapping EPS and PDS features, particularly in secondary and tertiary care. 7
Functional Abdominal Bloating and Distention
Rome IV created a separate category for functional bloating and distention, acknowledging this can be a primary disorder distinct from IBS, functional constipation, functional diarrhea, or functional dyspepsia. 7
When Rome IV criteria for functional bloating/distention are met, the patient should NOT simultaneously fulfill criteria for IBS, functional constipation, functional diarrhea, or FD. 7 However, bloating and distention are present in over 50% of patients with these other DGBIs. 7
Global prevalence of isolated functional bloating/distention is 3.5% (4.6% in women, 2.4% in men). 7
Critical Diagnostic Pitfalls
Location and Character of Pain Matters
In IBS, abdominal pain is typically located in the lower abdomen, related to defecation, and associated with changes in bowel habits but not necessarily related to meals. 2
In functional dyspepsia, pain is localized to the epigastrium, may occur during fasting or be precipitated by meals, and is NOT related to the need to defecate. 2
Up to 50% of patients with functional dyspepsia have overlap with IBS, reporting two different types of abdominal pain: one related to defecation and one not. 2
Distinguishing FD from GERD
Do not confuse functional dyspepsia with gastroesophageal reflux disease - burning that starts in the epigastrium but radiates to the chest suggests GERD, not functional dyspepsia. 2 Heartburn alone is not a dyspeptic symptom, though it can coexist. 7
FD versus Gastroparesis
Functional dyspepsia and gastroparesis have significant overlapping features that cannot be fully distinguished based on symptoms or gastric emptying studies alone. 7, 8 The term "FD with or without delayed gastric emptying" may be preferable to avoid over-emphasizing motor deficits. 7, 8
Diagnostic Approach Algorithm
Step 1: Exclude Red Flags
Evaluate for warning signs requiring further investigation: 3
- Weight loss
- Rectal bleeding
- Anemia
- Nocturnal symptoms
- Family history of colorectal cancer or inflammatory bowel disease
Step 2: Apply Symptom-Based Criteria
For IBS: Confirm abdominal pain (not just discomfort) at least 1 day per week for 3 months, with onset 6 months prior, plus two of: related to defecation, change in stool frequency, or change in stool form 3, 4
For FD: Confirm bothersome epigastric symptoms (pain, burning, postprandial fullness, or early satiation) for 3 months, with onset 6 months prior 7, 8
Step 3: Limited Diagnostic Testing
For IBS: Baseline stool hemoccult and complete blood count; consider sigmoidoscopy if colonic symptoms present 3
For FD: Upper endoscopy is required by definition to exclude structural disease 7, 8
Step 4: Subtype Classification
IBS subtypes based on predominant stool pattern: IBS with constipation (IBS-C), IBS with diarrhea (IBS-D), mixed IBS, or unsubtyped IBS 3
FD subtypes: EPS (pain/burning ≥1 day/week) versus PDS (fullness/early satiation ≥3 days/week) 7, 8
Clinical Considerations
The Rome IV criteria were developed primarily for research standardization but have evolved to be more clinically applicable. 3, 4 However, they identify patients with more severe symptoms and higher psychological comorbidity compared to Rome III. 3
Symptoms often fluctuate over time, and subtype classification may change. 3 Functional disorders frequently overlap with each other. 3
Once a functional diagnosis is established using appropriate criteria and limited investigation, the incidence of new non-functional diagnoses is extremely low. 3