Functional Dyspepsia (Rome IV; postprandial distress syndrome / epigastric pain syndrome / overlap; H. pylori-associated dyspepsia; FD-GERD/IBS overlap)
Encounter flow
12/12 authoredCanonical 12-phase frame with authored status for this dossier.
Frame
Apply Rome IV POSITIVE diagnosis of functional dyspepsia: ≥1 of bothersome postprandial fullness, early satiation, epigastric pain, epigastric burning, with NO structural disease (including upper endoscopy where indicated) explaining the symptoms; onset ≥6 months ago, criteria active ≥3 months. Assign subtype — PDS (postprandial fullness/early satiation ≥3 days/wk), EPS (epigastric pain/burning ≥1 day/wk), or PDS-EPS overlap. NOT a diagnosis of exclusion once the test-and-treat/EGD pathway is satisfied (Rome IV; Stanghellini 2016 PMID 27147122; ACG/CAG 2017 PMID 28631728)
Rome IV criteria met and PDS / EPS / overlap subtype assigned
Patient inputs (18)
The pivotal test-and-treat vs early-endoscopy fork: age ≥60 with new dyspepsia mandates upfront EGD; age <60 without alarms → non-invasive H. pylori test-and-treat (ACG/CAG 2017 PMID 28631728)
Sex informs pre-test probability and drug selection (QT-prolonging prokinetics, TCA tolerability) (ACG/CAG 2017)
First-degree family history of gastric/oesophageal cancer is an alarm feature lowering the EGD threshold even age <60 (ACG/CAG 2017; Maastricht VI 2022)
Rome IV PDS criterion — bothersome postprandial fullness and/or early satiation ≥3 days/week; selects prokinetic / buspirone / mirtazapine axis (Rome IV; Stanghellini 2016 PMID 27147122)
Rome IV EPS criterion — bothersome epigastric pain and/or burning ≥1 day/week; selects PPI / TCA axis (Talley 2015 PMID 26116797)
Rome IV requires symptom onset ≥6 months ago and active criteria for the last 3 months — a strict temporal anchor of the positive diagnosis (Rome IV)
Urea breath test or stool antigen (off PPI ≥2 wk, off antibiotics/bismuth ≥4 wk) is the core test-and-treat investigation; eradication is potentially curative in the H. pylori-associated subset (Ford 2022 PMID 35022266 — eradicated NNT 4.5)
Iron-deficiency anaemia is an alarm feature mandating EGD; baseline before therapy
Unintentional weight loss, dysphagia, odynophagia, GI bleeding/iron-deficiency anaemia, persistent vomiting, palpable mass/lymphadenopathy, family history of upper-GI cancer — each overrides a functional diagnosis and mandates EGD ± organic workup (ACG/CAG 2017 PMID 28631728)
Anxiety/depression are bidirectionally linked to FD via the gut-brain axis and modify therapy selection (neuromodulators, psychological therapy) — screen with PHQ-9/GAD-7 (ACG/CAG 2017; Talley 2015 PMID 26116797)
NSAID/aspirin use produces dyspepsia and peptic ulceration — review and stop before labelling functional (ACG/CAG 2017)
Misoprostol is teratogenic (abortifacient — contraindicated); some prokinetics and bismuth-quadruple components require avoidance/caution; dietary and PPI safety tiers apply in pregnancy/lactation (ACG/CAG 2017)
Predominant heartburn/regurgitation routes to gi.gerd.core.v1; FD-GERD overlap is common and managed jointly (Rome IV; ACG/CAG 2017)
Concurrent Rome IV IBS (pain related to defecation / altered bowel habit) — ~30% overlap; shared gut-brain neuromodulation; route gi.ibs.core.v1 (Rome IV)
CMP/LFT screen excludes hepatobiliary/pancreatic and metabolic mimics of epigastric symptoms; renal/hepatic function guides PPI/TCA/prokinetic dosing
Thyroid dysfunction and (with glucose) diabetic gastroparesis mimic PDS — checked when emptying-type symptoms dominate or are atypical
Penicillin allergy excludes amoxicillin-containing H. pylori regimens → bismuth quadruple or levofloxacin-based alternative (ACG H. pylori 2024 PMID 39626064)
Renal dosing of prokinetics (metoclopramide accumulation/EPS risk) and adjustment of H. pylori regimen components; eGFR via calc.ckd_epi_2021
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Severity triggers (8)
- informationalseverealarm_feature_or_age_60_new_onsetAny alarm feature — unintentional weight loss, dysphagia, odynophagia, GI bleeding/iron-deficiency anaemia, persistent vomiting, palpable mass/lymphadenopathy, family history upper-GI cancer — OR age ≥60 with new-onset dyspepsia (ACG/CAG 2017 PMID 28631728)Trigger could not be auto-evaluated — needs clinician judgement.
- informationalseveresevere_psych_comorbidity_or_suicidalitySevere depression/anxiety or positive PHQ-9 item 9 (suicidality) in an FD patient (ACG/CAG 2017; bidirectional gut-brain axis)Trigger could not be auto-evaluated — needs clinician judgement.
- informationalseveresignificant_weight_loss_or_dehydrationSignificant unintentional weight loss, dehydration, or persistent vomiting in a dyspeptic patient (ACG/CAG 2017)Trigger could not be auto-evaluated — needs clinician judgement.
- informationalseveremetoclopramide_extrapyramidal_signsAcute dystonia, akathisia, parkinsonism, or tardive-dyskinesia features in a patient on metoclopramide (FDA boxed warning) (ACG/CAG 2017)Trigger could not be auto-evaluated — needs clinician judgement.
- informationalmoderaterefractory_after_eradication_ppi_neuromodulatorPersistent FD symptoms after confirmed H. pylori eradication (or H. pylori-negative) + an adequate PPI trial + ≥1 gut-brain neuromodulator (ACG/CAG 2017)Trigger could not be auto-evaluated — needs clinician judgement.
- informationalmoderatepregnancy_lactation_drug_safety_gatePregnant or lactating FD patient — drug-safety tiering required (ACG/CAG 2017; PPI-in-pregnancy MA PMID 37269915)Trigger could not be auto-evaluated — needs clinician judgement.
- informationalmoderateelderly_stopp_inappropriate_prescriptionAge ≥65 on metoclopramide or a TCA for FD — STOPP/START v3 potentially-inappropriate medication review (O'Mahony 2023 PMID 37256475)Trigger could not be auto-evaluated — needs clinician judgement.
- informationalmildppi_over_8_weeks_no_benefitPPI continued ≥8 weeks without symptomatic benefit in functional dyspepsia (ACG/CAG 2017; STOPP v3)Trigger could not be auto-evaluated — needs clinician judgement.
Workflow calculators
Run this disease's risk and dosing calculators inline.
Recommended regimen
Functional dyspepsia stepwise subtype-directed therapy (ACG/CAG 2017 + AGA white paper 2017 — PDS/EPS tiers)- h_pylori_test_and_treat_strategyfirst linediagnostic_therapeutic_strategytriggers: age_under_60, no_alarm_features, fd_any_subtypeACG/CAG 2017 PMID 28631728 — non-invasive urea breath test / stool antigen, eradicate if positive; potentially curative subset (Ford 2022 PMID 35022266 — eradicated NNT 4.5)
- diet_lifestyle_small_low_fat_mealsfirst linelifestylesmall frequent low-fat meals; reduce caffeine/alcohol/late meals • dietary • ongoingtriggers: fd_any_subtypeACG/CAG 2017 — dietary modification reduces meal-related symptoms; duodenal-eosinophilia mechanism supports dietary effect (Wauters 2021 PMID 33346007)
- discontinue_nsaid_aspirin_iron_bisphosphonatefirst linedeprescribingtriggers: nsaid_or_aspirin_use, fd_any_subtypeACG/CAG 2017 — medication-induced dyspepsia must be excluded; stop/replace the offending agent before labelling functional
outpatient playbook — drug actions (5)
- 1. H. pylori test-and-treat (age <60, no alarm)eradicate if positive — bismuth quadruple or clarithromycin triple by local resistance • PO • 14-day coursetrigger: H. pylori positiveACG/CAG 2017; Ford 2022 PMID 35022266 (eradicated NNT 4.5)
- 2. PPI (EPS/overlap)omeprazole 20 mg daily before breakfast × 4-8 wk • PO • once dailytrigger: EPS/overlap, H. pylori-negative or post-eradicationPinto-Sanchez Cochrane PMID 29161458 (NNTB 13); deprescribe at 8 wk if no response
- 3. prokinetic (PDS)metoclopramide 5-10 mg TID ≤12 wk, OR domperidone 10 mg TID (ECG) • PO • TIDtrigger: PDS persistentACG/CAG 2017 — short-course only (boxed warning)
- 4. gut-brain neuromodulatoramitriptyline 10 mg nightly (EPS); mirtazapine 15 mg (early satiety/weight loss); buspirone 10 mg TID (PDS/accommodation) • PO • nightly / TIDtrigger: Refractory after Steps 1-3Talley 2015 PMID 26116797; Tack 2016 PMID 26538208; Tack 2012 PMID 22813445
- 5. psychological therapyCBT / gut-directed hypnotherapy / psychotherapy • behavioural • structured coursetrigger: Refractory FDACG/CAG 2017; AGA white paper 2017 PMID 28529164
Auto-drafted A&P note
outpatientSubjective
- Possible entry pathways: Bothersome postprandial fullness and/or early satiation — postprandial distress syndrome (PDS) (Rome IV; Stanghellini 2016 PMID 27147122); Bothersome epigastric pain and/or epigastric burning — epigastric pain syndrome (EPS) (Rome IV); Known functional dyspepsia on problem list (refractory-symptom / therapy-review visit) (ACG/CAG 2017).
Objective
- No vitals, labs, or imaging entered for this encounter.
Assessment
**Functional Dyspepsia (Rome IV; postprandial distress syndrome / epigastric pain syndrome / overlap; H. pylori-associated dyspepsia; FD-GERD/IBS overlap)** (gi.functional-dyspepsia.core.v1). Phenotype framing: Distinguish functional dyspepsia (PDS / EPS / overlap) from: peptic ulcer disease (H. pylori / NSAID), GORD and FD-GERD overlap, gastric/oesophageal malignancy, gastroparesis (delayed 4-h scintigraphy — distinct entity though overlapping), chronic nausea-vomiting syndrome, biliary/pancreatic disease (chronic pancreatitis, sphincter-of-Oddi, gallstones), medication-induced dyspepsia (NSAID/aspirin/iron/bisphosphonate), coeliac disease, eosinophilic gastritis/EoE, IBS overlap, and centrally-mediated abdominal pain. Confirm Rome IV subtype and H. pylori-associated vs H. pylori-negative phenotype (Rome IV; ACG/CAG 2017) Scope: Apply Rome IV POSITIVE diagnosis of functional dyspepsia: ≥1 of bothersome postprandial fullness, early satiation, epigastric pain, epigastric burning, with NO structural disease (including upper endoscopy where indicated) explaining the symptoms; onset ≥6 months ago, criteria active ≥3 months. Assign subtype — PDS (postprandial fullness/early satiation ≥3 days/wk), EPS (epigastric pain/burning ≥1 day/wk), or PDS-EPS overlap. NOT a diagnosis of exclusion once the test-and-treat/EGD pathway is satisfied (Rome IV; Stanghellini 2016 PMID 27147122; ACG/CAG 2017 PMID 28631728) No severity triggers fired against current inputs.
Plan
Regimen axis: **Functional dyspepsia stepwise subtype-directed therapy (ACG/CAG 2017 + AGA white paper 2017 — PDS/EPS tiers)** — step "Step 1 — All: H. pylori test-and-treat (age <60, no alarm) + lifestyle; stop offending drugs". 1. h_pylori_test_and_treat_strategy (diagnostic_therapeutic_strategy, first line) — ACG/CAG 2017 PMID 28631728 — non-invasive urea breath test / stool antigen, eradicate if positive; potentially curative subset (Ford 2022 PMID 35022266 — eradicated NNT 4.5) 2. diet_lifestyle_small_low_fat_meals small frequent low-fat meals; reduce caffeine/alcohol/late meals dietary ongoing (lifestyle, first line) — ACG/CAG 2017 — dietary modification reduces meal-related symptoms; duodenal-eosinophilia mechanism supports dietary effect (Wauters 2021 PMID 33346007) 3. discontinue_nsaid_aspirin_iron_bisphosphonate (deprescribing, first line) — ACG/CAG 2017 — medication-induced dyspepsia must be excluded; stop/replace the offending agent before labelling functional Setting playbook (outpatient) — Primary-care Rome IV positive diagnosis, alarm-feature/age screen, age-<60 test-and-treat fork, empiric stepwise therapy + lifestyle (ACG/CAG 2017 PMID 28631728) 4. H. pylori test-and-treat (age <60, no alarm) eradicate if positive — bismuth quadruple or clarithromycin triple by local resistance PO 14-day course — H. pylori positive (ACG/CAG 2017; Ford 2022 PMID 35022266 (eradicated NNT 4.5)) 5. PPI (EPS/overlap) omeprazole 20 mg daily before breakfast × 4-8 wk PO once daily — EPS/overlap, H. pylori-negative or post-eradication (Pinto-Sanchez Cochrane PMID 29161458 (NNTB 13); deprescribe at 8 wk if no response) 6. prokinetic (PDS) metoclopramide 5-10 mg TID ≤12 wk, OR domperidone 10 mg TID (ECG) PO TID — PDS persistent (ACG/CAG 2017 — short-course only (boxed warning)) 7. gut-brain neuromodulator amitriptyline 10 mg nightly (EPS); mirtazapine 15 mg (early satiety/weight loss); buspirone 10 mg TID (PDS/accommodation) PO nightly / TID — Refractory after Steps 1-3 (Talley 2015 PMID 26116797; Tack 2016 PMID 26538208; Tack 2012 PMID 22813445) 8. psychological therapy CBT / gut-directed hypnotherapy / psychotherapy behavioural structured course — Refractory FD (ACG/CAG 2017; AGA white paper 2017 PMID 28529164) Non-pharmacologic actions: - Small frequent low-fat meals; reduce caffeine/alcohol/late meals (ACG/CAG 2017) - Stop offending NSAID/aspirin/iron/bisphosphonate (ACG/CAG 2017) - Confirm H. pylori eradication ≥4 wk post-therapy (ACG H. pylori 2024 PMID 39626064) - Deprescribe PPI at 8 wk if no benefit (protocol.deprescribing_ppi) - Reassess for emergent alarm features at each visit (ACG/CAG 2017) AVOID / contraindication checks: - Metoclopramide FDA boxed warning — tardive dyskinesia / extrapyramidal reactions; limit total exposure ≤12 weeks, lowest effective dose, AVOID in elderly, Parkinsonism, and with other dopamine antagonists (ACG/CAG 2017) - Domperidone QT prolongation / sudden cardiac death — baseline + interval ECG, avoid with QT prolonging drugs / hypokalaemia / significant cardiac disease; not FDA approved in US (ACG/CAG 2017) - TCA (amitriptyline/nortriptyline) cardiac conduction (baseline ECG if risk), anticholinergic burden, urinary retention, fall/sedation in elderly (STOPP); avoid in known QT prolongation - Clarithromycin based H. pylori triple therapy only where local clarithromycin resistance <15% or known susceptible; otherwise bismuth quadruple (macrolide DDIs: statins, QT drugs) (ACG H. pylori 2024 PMID 39626064; Maastricht VI 2022 PMID 35944925) - Penicillin allergy → amoxicillin free H. pylori regimen (bismuth quadruple or levofloxacin based) (ACG H. pylori 2024 PMID 39626064) - Misoprostol contraindicated in pregnancy (abortifacient); avoid select prokinetics; PPI/dietary preferred in pregnancy/lactation (ACG/CAG 2017) - PPI ≥8 weeks without benefit → deprescribe (step down/on demand/stop with rebound acid counselling) — protocol.deprescribing_ppi (STOPP v3) - Metoclopramide / H. pylori regimen renal dose review via calc.ckd_epi_2021 (KDIGO 2024)
Monitoring
Regimen monitoring: - Symptom response at 4-8 wk per agent; PPI reassessed at 8 wk → deprescribe if no benefit (ACG/CAG 2017) - Confirm H. pylori eradication by urea breath test / stool antigen ≥4 wk post-therapy, off PPI ≥2 wk (ACG H. pylori 2024 PMID 39626064) - Metoclopramide — extrapyramidal/tardive-dyskinesia surveillance; cap exposure ≤12 weeks (FDA boxed warning) - Domperidone — baseline + interval QTc (ACG/CAG 2017) - TCA — QTc at higher dose, anticholinergic AEs, PHQ-9/GAD-7 trend, suicidality re-screen (Talley 2015 PMID 26116797) - Mirtazapine — weight/appetite response, sedation; buspirone — meal-timed dosing adherence (Tack 2016 PMID 26538208; Tack 2012 PMID 22813445) - Renal function for metoclopramide / H. pylori-regimen dosing (calc.ckd epi 2021) Setting (outpatient) monitoring: - Symptom response at 4-8 wk per agent (ACG/CAG 2017) - H. pylori eradication confirmation by UBT/stool antigen (ACG H. pylori 2024 PMID 39626064) - Metoclopramide extrapyramidal surveillance ≤12 wk; domperidone QTc (ACG/CAG 2017) - PHQ-9 / GAD-7 trend on neuromodulator; suicidality re-screen (Talley 2015 PMID 26116797) Follow-up plan: Mild disease: review at 4-8 weeks then as needed with self-management education and return precautions (new alarm feature). Moderate-severe / refractory: structured follow-up q4-12 weeks during stepwise escalation; reinforce diet/lifestyle (small low-fat meals, reduce caffeine/alcohol, weight-bearing meals), the chronic relapsing-remitting natural history, and multidisciplinary coordination (dietitian, psychology, neurogastroenterology). Reassess the diagnosis if response is atypical or alarm features emerge (ACG/CAG 2017; AGA white paper 2017 PMID 28529164) - Close-out criterion: follow-up interval, self-management plan, and multidisciplinary referrals scheduled Monitoring phase: Reassess symptom response at 4-8 weeks per agent; confirm H. pylori eradication by urea breath test / stool antigen ≥4 weeks post-therapy (off PPI ≥2 wk); review PPI at 8 weeks and DEPRESCRIBE if no benefit (protocol.deprescribing_ppi); metoclopramide — screen for extrapyramidal/tardive-dyskinesia signs and cap exposure ≤12 weeks; domperidone — baseline/interval QTc; TCA — anticholinergic burden, QTc at higher dose, fall/sedation risk (elderly STOPP); PHQ-9/GAD-7 trend on neuromodulator; renal function for dose adjustment (calc.ckd_epi_2021); re-screen for emergent alarm features (any new alarm → re-enter RED_FLAGS / EGD) (ACG/CAG 2017; ACG H. pylori 2024 PMID 39626064)
Disposition
Current setting: outpatient — Primary-care Rome IV positive diagnosis, alarm-feature/age screen, age-<60 test-and-treat fork, empiric stepwise therapy + lifestyle (ACG/CAG 2017 PMID 28631728) Disposition criteria: - Continue primary-care management if responding and no alarm features (ACG/CAG 2017) - Refer to GI for age ≥60/alarm (EGD), diagnostic uncertainty, refractory disease, suspected gastroparesis (ACG/CAG 2017) - Refer to psychology/psychiatry for severe affective comorbidity or suicidality (ACG/CAG 2017) Escalation triggers (move to higher acuity): - New alarm feature or age ≥60 new onset → upper endoscopy / GI referral (ACG/CAG 2017) - Refractory after H. pylori eradication + PPI + a neuromodulator → GI/neurogastroenterology referral (ACG/CAG 2017) - Significant unintentional weight loss / dehydration / persistent vomiting → organic workup / acute care (ACG/CAG 2017) - Severe psychological comorbidity / positive PHQ-9 Q9 suicidality → psychiatry, safety plan (ACG/CAG 2017)
Earlier-Return Triggers
Return-precaution thresholds (watch for): - [SEVERE] Any alarm feature — unintentional weight loss, dysphagia, odynophagia, GI bleeding/iron-deficiency anaemia, persistent vomiting, palpable mass/lymphadenopathy, family history upper-GI cancer — OR age ≥60 with new-onset dyspepsia (ACG/CAG 2017 PMID 28631728) - [SEVERE] Severe depression/anxiety or positive PHQ-9 item 9 (suicidality) in an FD patient (ACG/CAG 2017; bidirectional gut-brain axis) - [SEVERE] Significant unintentional weight loss, dehydration, or persistent vomiting in a dyspeptic patient (ACG/CAG 2017)
Citations
- ACG/CAG 2017 Dyspepsia Clinical Guideline (Moayyedi AJG 2017) + AGA White Paper Functional Dyspepsia + Rome IV gastroduodenal disorders (Stanghellini 2016) + ACG H. pylori 2024 (Chey) + Maastricht VI/Florence H. pylori 2022 [PMID:28631728](https://pubmed.ncbi.nlm.nih.gov/28631728/) - Cited evidence (PMID 28529164) [PMID:28529164](https://pubmed.ncbi.nlm.nih.gov/28529164/) - Cited evidence (PMID 27147122) [PMID:27147122](https://pubmed.ncbi.nlm.nih.gov/27147122/) - Cited evidence (PMID 39626064) [PMID:39626064](https://pubmed.ncbi.nlm.nih.gov/39626064/) - Cited evidence (PMID 35944925) [PMID:35944925](https://pubmed.ncbi.nlm.nih.gov/35944925/) Last reconciled with current guidelines: 2026-05-17.
- ACG/CAG 2017 Dyspepsia Clinical Guideline (Moayyedi AJG 2017) + AGA White Paper Functional Dyspepsia + Rome IV gastroduodenal disorders (Stanghellini 2016) + ACG H. pylori 2024 (Chey) + Maastricht VI/Florence H. pylori 2022 — PMID:28631728
- Cited evidence (PMID 28529164) — PMID:28529164
- Cited evidence (PMID 27147122) — PMID:27147122
- Cited evidence (PMID 39626064) — PMID:39626064
- Cited evidence (PMID 35944925) — PMID:35944925