Rome Criteria for Functional Gastrointestinal Disorders
The Rome IV criteria are the current gold standard for diagnosing functional GI disorders, requiring recurrent symptoms for at least 3 months with onset at least 6 months prior to diagnosis, though less restrictive "clinical criteria" requiring only 8 weeks of symptoms are now recommended for routine practice. 1, 2
Irritable Bowel Syndrome (IBS)
Rome IV Criteria (Current Standard)
IBS requires 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 the following: 1, 2, 3
- Pain related to defecation (can improve OR worsen with bowel movements) 4
- Change in stool frequency 1, 3
- Change in stool form/appearance 1, 3
Key Changes from Earlier Iterations
Rome IV eliminated "discomfort" as a diagnostic criterion because it is non-specific and has different meanings across languages—only pain is now required. 4
The Manning criteria (historical precursor) included six symptoms: 1, 3
- Abdominal pain relieved by defecation
- Looser stools with onset of pain
- More frequent stools with onset of pain
- Abdominal distension
- Passage of mucus in stools
- Sensation of incomplete evacuation
Rome I criteria required at least 3 months of recurrent symptoms with abdominal pain/discomfort relieved with defecation or associated with change in stool frequency/consistency, plus two or more supportive features (altered stool frequency, altered stool form, altered stool passage, passage of mucus, bloating/distension) on at least 25% of occasions. 1, 3
Rome II criteria required 12 weeks or more in the last 12 months of abdominal discomfort/pain with two of three features: relieved by defecation, associated with change in frequency of stool, or associated with change in consistency of stool. 1, 3
Clinical Impact of Rome IV Restrictions
Rome IV criteria are substantially more restrictive than Rome III, reducing global IBS prevalence from 10.1% to 4.1%, with up to 50% of patients who met Rome III criteria no longer qualifying for IBS diagnosis. 1, 2, 3 These patients are now reclassified as having other functional bowel disorders such as functional diarrhea, functional constipation, or functional abdominal bloating. 1, 3
Rome IV identifies patients with more severe symptoms and higher psychological comorbidity compared to Rome III. 1, 2, 3
Supportive Clinical Features
The diagnosis is more likely if the patient is female, aged <45 years with symptom history >2 years, and has attended frequently in the past with non-gastrointestinal symptoms. 1, 3
Red Flags Requiring Investigation
If symptoms are atypical, history is short, or patient is over 45 years, perform further investigations including: 1
- Sigmoidoscopy or colonoscopy (especially with family history of colon cancer) 1
- Complete blood count to exclude anemia 1
- Thyroid function tests 1
- Antiendomysial antibodies (for celiac disease) 1
- Stool microscopy 1
Warning signs mandating investigation regardless of age include: weight loss, rectal bleeding, nocturnal symptoms, or anemia. 1
Functional Dyspepsia (FD)
Rome IV Criteria
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. 1, 2
"Bothersome" specifically means symptoms severe enough to impact usual activities. 1, 2
Clinical Criteria for Routine 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—the new "clinical criteria" require only 8 weeks of cardinal symptoms for practical use. 1, 2
FD Subtypes
Epigastric Pain Syndrome (EPS) requires one or both of the following at least 1 day per week: 1, 2
- Bothersome epigastric pain (severe enough to impact usual activities)
- Bothersome epigastric burning (severe enough to impact usual activities)
Pain may be induced by meals, relieved by meals, or occur while fasting. 1
Postprandial Distress Syndrome (PDS) requires one or both of the following at least 3 days per week: 1, 2
- Bothersome postprandial fullness (severe enough to impact usual activities)
- Bothersome early satiation (severe enough to prevent finishing a regular-sized meal)
Critical Diagnostic Requirements
Upper endoscopy is required by definition to exclude structural disease in functional dyspepsia. 1, 2 Approximately 80% of patients with dyspepsia symptoms will have functional dyspepsia after endoscopy excludes structural disease. 2
Important Exclusions
Heartburn is not a dyspeptic symptom, but may often coexist. 1
Symptoms relieved by evacuation of feces or gas should generally not be considered as part of dyspepsia. 1
Persistent vomiting likely suggests another disorder. 1
Functional Constipation
Rome IV categorizes disorders of chronic constipation into four subtypes: functional constipation, IBS with constipation (IBS-C), opioid-induced constipation, and functional defecation disorders (including inadequate defecatory propulsion and dyssynergic defecation). 5
Functional bowel disorders (functional diarrhea, functional constipation, IBS-D, IBS-C, and IBS with mixed bowel habits) are considered to be on a continuum rather than as independent entities. 4
Functional Abdominal Bloating and Distention
Rome IV has a separate category for abdominal bloating and distention, acknowledging this can be a primary disorder with a global prevalence as high as 3.5% (4.6% in women and 2.4% in men). 1
When Rome IV diagnostic criteria for functional abdominal bloating and distention are met, the patient should not fulfill criteria for IBS, functional constipation, functional diarrhea, or functional dyspepsia. 1
Bloating and distention are much more prevalent (>50%) when associated with other disorders of gut-brain interaction. 1
Critical Clinical Pitfalls
The Rome criteria were initially developed for research purposes with pharmaceutical industry support to allow greater comparability between drug studies—they should not become a straitjacket to prevent clinical judgment. 1, 3
Many patients with abdominal pain and disturbed bowel habit do not exactly fit these criteria, yet their clinical course is similar. 1
Once a functional diagnosis is established using appropriate criteria and limited investigation, the incidence of new non-functional diagnoses is extremely low. 1, 2
Functional disorders frequently overlap with each other, complicating diagnosis, and symptoms often fluctuate over time with subtype classification potentially changing. 3
Terminology Update
Functional gastrointestinal disorders (FGIDs) are now called disorders of gut-brain interaction (DGBI) in Rome IV, reflecting the multicultural rather than Western-culture focus. 4