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Functional DyspepsiaFD-CBTNCT07577089

Cognitive Behavioral Therapy for Functional Dyspepsia (Epigastric Pain Syndrome and Postprandial Distress Syndrome Subtypes)

A study testing Optimized Standard Treatment (OPT) and Cognitive Behavioral Therapy + Optimized Standard Treatment (CBT + OPT) in people with Functional Dyspepsia and Epigastric Pain Syndrome, run by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The goal of this clinical trial is to learn whether adding Cognitive Behavioral Therapy (CBT) to standard medical treatment can improve symptoms in adults with Functional Dyspepsia. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Optimized Standard Treatment (OPT) and Cognitive Behavioral Therapy + Optimized Standard Treatment (CBT + OPT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
No sites listed yet
Study dates
Apr 2026to Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18-65 years
  • Diagnosis of Functional Dyspepsia according to Rome IV criteria
  • Classification as Epigastric Pain Syndrome (EPS) or Postprandial Distress Syndrome (PDS)
  • Active symptoms within the last month
  • Willingness to participate in Cognitive Behavioral Therapy and provide biological samples for research
  • Ability to provide written informed consent

Who cannot join

  • Presence of structural gastrointestinal disease (e.g., peptic ulcer, malignancy)
  • History of major abdominal surgery affecting the stomach or small intestine
  • Severe psychiatric disorders (e.g., psychosis, bipolar disorder) interfering with participation
  • Current participation in other interventional clinical trials
  • Use of medications that may confound study outcomes (e.g., chronic corticosteroids, immunosuppressants)
  • Pregnancy or breastfeeding

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Laura Prospero, Psychologist contact

+390804994274

laura.prospero@irccsdebellis.it

Francesco Russo, MD contact

+390804994129

francesco.russo@irccsdebellis.it

About this study

Official title: Multimodal Phenotyping of Functional Dyspepsia: Controlled Trial on Response to Cognitive-Behavioral Therapy in Subtypes of Epigastric Pain Syndrome and Postprandial Discomfort Syndrome

The goal of this clinical trial is to learn whether adding Cognitive Behavioral Therapy (CBT) to standard medical treatment can improve symptoms in adults with Functional Dyspepsia. The study includes adults aged 18 to 65 years diagnosed with Functional Dyspepsia, classified as Epigastric Pain Syndrome or Postprandial Distress Syndrome.

The main questions it aims to answer are:

Read more

Does Cognitive Behavioral Therapy added to standard treatment reduce gastrointestinal symptoms compared with standard treatment alone? Do patients with Postprandial Distress Syndrome and Epigastric Pain Syndrome respond differently to Cognitive Behavioral Therapy? Researchers will compare optimized standard medical treatment alone to optimized standard treatment combined with Cognitive Behavioral Therapy to see if the addition of CBT leads to greater symptom improvement and better quality of life.

Participants will:

Be randomly assigned to receive either standard medical treatment alone or standard treatment plus Cognitive Behavioral Therapy Take part in clinical visits and complete questionnaires about gastrointestinal symptoms, psychological well-being, and quality of life Provide blood, saliva, and stool samples at several time points over a 12-month follow-up period

Read the detailed description

Functional Dyspepsia is a chronic disorder of gut-brain interaction characterized by persistent upper gastrointestinal symptoms in the absence of structural disease. It is commonly classified into Epigastric Pain Syndrome and Postprandial Distress Syndrome, which may reflect partially distinct underlying mechanisms. Standard medical treatments often provide incomplete symptom relief, and growing evidence supports a role for psychological factors and gut-brain axis dysregulation in symptom generation and persistence.

This randomized controlled trial investigates the effectiveness of adding a manualized Cognitive Behavioral Therapy program to optimized standard medical treatment in adults with Functional Dyspepsia. Participants are stratified by dyspepsia subtype and randomly assigned in a 1:1 ratio to receive either optimized standard treatment alone or optimized standard treatment combined with Cognitive Behavioral Therapy. Outcome assessors are blinded to treatment allocation.

The Cognitive Behavioral Therapy intervention is delivered individually by trained therapists and focuses on psychoeducation, cognitive restructuring, stress management, coping strategies, and behavioral and interoceptive exposure. The intervention is designed to target symptom-related cognitions, emotional responses, and behavioral patterns that may contribute to symptom persistence.

In addition to evaluating clinical efficacy, the study adopts a multimodal approach to characterize biological, psychological, and clinical factors associated with treatment response. Data collection includes clinical and psychological assessments and the collection of biological samples to explore markers related to inflammation, stress regulation, gut barrier function, and gut microbiota composition and activity. Measurements are obtained at baseline and during follow-up to assess changes over time and their relationship with symptom improvement.

The study aims to identify predictors of response to Cognitive Behavioral Therapy and to explore differences between Epigastric Pain Syndrome and Postprandial Distress Syndrome. By integrating clinical, psychological, and biological data, the trial seeks to support a more personalized treatment approach for Functional Dyspepsia and to improve the targeting of psychological interventions in clinical practice.

Being tested
Optimized Standard Treatment (OPT), Cognitive Behavioral Therapy + Optimized Standard Treatment (CBT + OPT)
Keywords
Functional Dyspepsia, Cognitive Behavioral Therapy, Epigastric Pain Syndrome, Postprandial Distress Syndrome, Gut-Brain Axis, Microbiota, Randomized Controlled Trial, Disorders of Gut-Brain Interaction, Gastrointestinal Symptoms, Inflammation, Biomarkers, Precision Medicine
Medical subject headings
Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Optimized Standard Treatment (OPT)Drug

    Participants receive guideline-based standard medical treatment for Functional Dyspepsia, including proton pump inhibitors, antiacids, and prokinetics at recommended doses. This intervention does not include any psychological or behavioral therapy.

  • Cognitive Behavioral Therapy + Optimized Standard Treatment (CBT + OPT)Behavioural

    Participants receive the same optimized standard medical treatment as the OPT arm, plus a manualized Cognitive Behavioral Therapy program. CBT consists of 10 individual sessions (60 minutes each) over 12 weeks, with a 6-month booster session. Sessions cover psychoeducation, cognitive restructuring, stress management, coping strategies, interoceptive/behavioral exposure, relaxation, and nutritional integration.

Study groups in NCT07577089
Study groupRoleWhat they receive
Optimized Standard Treatment (OPT)ExperimentalParticipants receive standard medical treatment for Functional Dyspepsia, including proton pump inhibitors, antiacids, and prokinetics at standard doses, according to clinical guidelines. No additional psychological intervention is provided.
Receives: Drug: Optimized Standard Treatment (OPT)
Cognitive Behavioral Therapy + Optimized Standard Treatment (CBT + OPT)ExperimentalParticipants receive the same optimized standard medical treatment as the OPT arm, plus a manualized Cognitive Behavioral Therapy program. CBT consists of 10 individual sessions (60 minutes each) over 12 weeks, with a 6-month booster session. Sessions include psychoeducation, cognitive restructuring, stress management, coping strategies, interoceptive and behavioral exposure, relaxation, and nutritional integration. Adherence and engagement are monitored throughout the study.
Receives: Drug: Optimized Standard Treatment (OPT); Behavioral: Cognitive Behavioral Therapy + Optimized Standard Treatment (CBT + OPT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reduction in gastrointestinal symptom severity as assessed by the Leeds Dyspepsia Questionnaire - Short Form (LDQ-SF)

    The primary outcome is a statistically significant reduction in total LDQ-SF score in patients treated with CBT + optimized pharmacological treatment (OPT) compared to OPT alone, with an expected greater benefit in the Postprandial Distress Syndrome (PDS) subtype compared to the Epigastric Pain Syndrome (EPS) subtype. The LDQ-SF assesses the frequency and severity of dyspeptic symptoms (epigastric pain, heartburn, nausea, vomiting, early satiety, bloating, regurgitation, postprandial discomfort); scores range from 0 to 32, with higher scores indicating greater symptom severity. Responder status is defined as a ≥30-50% reduction in total LDQ-SF score from baseline.

    Measured: Baseline (T0), 3 months (T1 - end of intervention), 6 months (T2 - intermediate follow-up), 12 months (T3 - final follow-up)

Secondary outcomes (32)

  1. Anxiety and Depression - Hospital Anxiety and Depression Scale (HADS)

    Change from baseline in HADS total score and subscales (anxiety and depression) in CBT + OPT vs OPT alone. The HADS consists of 14 items divided into two subscales (anxiety and depression, 7 items each); each subscale ranges from 0 to 21, with higher scores indicating greater psychological distress. The total score ranges from 0 to 42.

    Measured: Baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3)

  2. Perceived Stress - Perceived Stress Scale (PSS)

    Change from baseline in perceived stress levels in CBT + OPT vs OPT alone. The PSS-10 consists of 10 items; scores range from 0 to 40, with higher scores indicating greater perceived stress.

    Measured: Baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3)

  3. Somatic Symptom Burden - Patient Health Questionnaire (PHQ-15)

    A 15-item measure of somatic symptom severity (range: 0-30). Higher scores indicate greater somatic symptom burden.

    Measured: Baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3)

  4. Patient Global Impression of Change (PGIC)

    Patient-reported subjective perception of overall improvement at each follow-up time point. A 7-point Likert scale assessing the patient's overall perception of improvement (range: 1-7). Higher scores indicate greater perceived improvement.

    Measured: Baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3)

  5. Visceral Anxiety - Visceral Sensitivity Index (VSI)

    A 15-item scale assessing gastrointestinal-specific anxiety (range: 0-75). Higher scores indicate greater anxiety and hypervigilance toward gastrointestinal sensations.

    Measured: Baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3)

  6. Serum Interleukin-6 (IL-6)

    Change from baseline in serum IL-6 levels (pg/mL) in CBT + OPT vs. OPT alone, as a marker of systemic inflammation.

    Measured: Baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3)

  7. Serum Interleukin-8 (IL-8)

    Change from baseline in serum IL-8 levels (pg/mL) in CBT + OPT vs. OPT alone, as a marker of systemic inflammation.

    Measured: Baseline (T0), 3 months (T1), 6 months (T2), 12 months (T3)

  8. Serum Interleukin-10 (IL-10)

    Change from baseline in serum IL-10 levels (pg/mL) in CBT + OPT vs. OPT alone, as a marker of anti-inflammatory response.

    Measured: Baseline (T0), 3 months (T1), 6 months (T2), 12 months (T3)

  9. Serum Tumor Necrosis Factor-alpha (TNF-α)

    Change from baseline in serum TNF-α levels (pg/mL) in CBT + OPT vs. OPT alone, as a marker of systemic inflammation.

    Measured: Baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3)

  10. High-sensitivity C-Reactive Protein (hs-CRP)

    Change from baseline in serum hs-CRP levels (mg/L) in CBT + OPT vs. OPT alone, as a marker of systemic low-grade inflammation.

    Measured: Baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3)

  11. Diurnal Salivary Cortisol Profile

    Change from baseline in diurnal salivary cortisol levels (nmol/L), measured at 4 time points across the day, in CBT + OPT vs. OPT alone, as a marker of hypothalamic-pituitary-adrenal (HPA) axis activity and stress regulation.

    Measured: Baseline (T0), 3 months (T1), 6 months (T2), 12 months (T3)

  12. Plasma Ghrelin

    Change from baseline in plasma ghrelin levels (pg/mL) in CBT + OPT vs. OPT alone, as a marker of appetite regulation and gut-brain axis signaling.

    Measured: Baseline (T0), 3 months (T1), 6 months (T2), 12 months (T3)

  13. Plasma Cholecystokinin (CCK)

    Change from baseline in plasma CCK levels (pg/mL) in CBT + OPT vs. OPT alone, as a marker of postprandial satiety signaling and gastrointestinal motility.

    Measured: Baseline (T0), 3 months (T1), 6 months (T2), 12 months (T3)

  14. Plasma Glucagon-Like Peptide-2 (GLP-2)

    Change from baseline in plasma GLP-2 levels (pg/mL) in CBT + OPT vs. OPT alone, as a marker of intestinal barrier integrity and mucosal growth.

    Measured: Baseline (T0), 3 months (T1), 6 months (T2), 12 months (T3)

  15. Plasma Peptide YY (PYY)

    Change from baseline in plasma PYY levels (pg/mL) in CBT + OPT vs. OPT alone, as a marker of postprandial satiety and gut motility regulation.

    Measured: Baseline (T0), 3 months (T1), 6 months (T2), 12 months (T3)

  16. Plasma Gastrin

    Change from baseline in plasma gastrin levels (pg/mL) in CBT + OPT vs. OPT alone, as a marker of gastric acid secretion and mucosal function.

    Measured: Baseline (T0), 3 months (T1), 6 months (T2), 12 months (T3)

  17. Plasma Motilin

    Change from baseline in plasma motilin levels (pg/mL) in CBT + OPT vs. OPT alone, as a marker of gastric motility and interdigestive motor activity.

    Measured: Baseline (T0), 3 months (T1), 6 months (T2), 12 months (T3)

  18. Plasma Leptin

    Change from baseline in plasma leptin levels (ng/mL) in CBT + OPT vs. OPT alone, as a marker of energy homeostasis and neuroendocrine regulation.

    Measured: Baseline (T0), 3 months (T1), 6 months (T2), 12 months (T3)

  19. Plasma Serotonin (5-HT)

    Change from baseline in plasma serotonin levels (ng/mL) in CBT + OPT vs. OPT alone, as a marker of enteric nervous system signaling and gut-brain communication.

    Measured: Baseline (T0), 3 months (T1), 6 months (T2), 12 months (T3)

  20. Plasma Brain-Derived Neurotrophic Factor (BDNF)

    Change from baseline in plasma BDNF levels (pg/mL) in CBT + OPT vs. OPT alone, as a marker of neuroplasticity and gut-brain axis modulation.

    Measured: Baseline (T0), 3 months (T1), 6 months (T2), 12 months (T3)

  21. Plasma Cortisol

    Change from baseline in plasma cortisol levels (nmol/L) in CBT + OPT vs. OPT alone, as a marker of hypothalamic-pituitary-adrenal (HPA) axis activation and physiological stress response.

    Measured: Baseline (T0), 3 months (T1), 6 months (T2), 12 months (T3)

  22. Fecal Zonulin

    Change from baseline in fecal zonulin levels (ng/mL) in CBT + OPT vs. OPT alone, as a marker of intestinal barrier permeability and tight junction regulation.

    Measured: Baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3)

  23. Fecal Calprotectin

    Change from baseline in fecal calprotectin levels (µg/g) in CBT + OPT vs. OPT alone, as a marker of intestinal mucosal inflammation.

    Measured: Baseline (T0), 3 months (T1), 6 months (T2), 12 months (T3)

  24. Gut Microbiota Alpha Diversity - Observed Species

    Change from baseline in observed species richness (count). Higher values indicate greater microbial richness.

    Measured: Baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3)

  25. Gut Microbiota Beta Diversity - UniFrac Distance

    Change from baseline in UniFrac distance (unitless), reflecting phylogenetic dissimilarity between microbial communities. Higher values indicate greater dissimilarity.

    Measured: Baseline (T0), 3 months (T1), 6 months (T2), 12 months (T3)

  26. Gut Microbiota Beta Diversity - Bray-Curtis Dissimilarity

    Change from baseline in Bray-Curtis dissimilarity index (unitless). Higher values indicate greater compositional differences.

    Measured: Baseline (T0), 3 months (T1 - end of intervention), 6 months (T2 - intermediate follow-up), 12 months (T3 - final follow-up)

  27. Relative Abundance of Faecalibacterium prausnitzii

    Change from baseline in relative abundance (%) assessed by 16S rRNA sequencing in CBT + OPT vs. OPT alone.

    Measured: Baseline (T0), 3 months (T1), 6 months (T2), 12 months (T3)

  28. Relative Abundance of Bifidobacterium spp.

    Change from baseline in relative abundance (%) assessed by 16S rRNA sequencing.

    Measured: Baseline (T0), 3 months (T1), 6 months (T2), 12 months (T3)

  29. Predicted Butyrate Production Pathway Abundance

    Change from baseline in predicted abundance (arbitrary units) derived from 16S rRNA data in CBT + OPT vs. OPT alone.

    Measured: Baseline (T0), 3 months (T1), 6 months (T2), 12 months (T3)

  30. Fecal Acetate

    Change from baseline in fecal acetate concentration (µmol/g) in CBT + OPT vs. OPT alone

    Measured: Baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3)

  31. Fecal Propionate

    Change from baseline in fecal propionate concentration (µmol/g).

    Measured: Baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3)

  32. Fecal Butyrate

    Change from baseline in fecal butyrate concentration (µmol/g).

    Measured: Baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2026
  2. Study startApr 2026 (estimated)
  3. Primary completionFeb 2027 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07577089
Sponsor's protocol ID
RC2026-22
Acronym
FD-CBT
Status last verified
May 2026
First submitted
11 Feb 2026
Last updated
11 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Huang Q, You F, Liang F, Ma C. Dietary microbes and functional dyspepsia: modulating the gut microecology for therapeutic benefit. Front Nutr. 2025 Aug 19;12:1625987. doi: 10.3389/fnut.2025.1625987. eCollection 2025.

    PubMed 40904772

  • Cheng M, Zhou XE, Xu YC, Dou HM. The efficacy of cognitive behavior stress management on functional dyspepsia: A protocol for systematic review and meta-analysis. Medicine (Baltimore). 2022 May 13;101(19):e29157. doi: 10.1097/MD.0000000000029157.

    PubMed 35583527

  • Sun E, Zhang X, Zhao Y, Li J, Sun J, Mu Z, Wang R. Beverages containing Lactobacillus paracasei LC-37 improved functional dyspepsia through regulation of the intestinal microbiota and their metabolites. J Dairy Sci. 2021 Jun;104(6):6389-6398. doi: 10.3168/jds.2020-19882. Epub 2021 Mar 11.

    PubMed 33714585

  • Singh V, Lee G, Son H, Koh H, Kim ES, Unno T, Shin JH. Butyrate producers, "The Sentinel of Gut": Their intestinal significance with and beyond butyrate, and prospective use as microbial therapeutics. Front Microbiol. 2023 Jan 12;13:1103836. doi: 10.3389/fmicb.2022.1103836. eCollection 2022.

    PubMed 36713166

  • Brown G, Hoedt EC, Keely S, Shah A, Walker MM, Holtmann G, Talley NJ. Role of the duodenal microbiota in functional dyspepsia. Neurogastroenterol Motil. 2022 Nov;34(11):e14372. doi: 10.1111/nmo.14372. Epub 2022 Apr 11.

    PubMed 35403776

  • Wei Z, Xing X, Tantai X, Xiao C, Yang Q, Jiang X, Hao Y, Liu N, Wang Y, Wang J. The Effects of Psychological Interventions on Symptoms and Psychology of Functional Dyspepsia: A Systematic Review and Meta-Analysis. Front Psychol. 2022 Apr 8;13:827220. doi: 10.3389/fpsyg.2022.827220. eCollection 2022.

    PubMed 35465581

Questions about this trial

What is this clinical trial studying?

A study testing Optimized Standard Treatment (OPT) and Cognitive Behavioral Therapy + Optimized Standard Treatment (CBT + OPT) in people with Functional Dyspepsia and Epigastric Pain Syndrome, run by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Laura Prospero, Psychologist (+390804994274, laura.prospero@irccsdebellis.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reduction in gastrointestinal symptom severity as assessed by the Leeds Dyspepsia Questionnaire - Short Form (LDQ-SF) (time frame: Baseline (T0), 3 months (T1 - end of intervention), 6 months (T2 - intermediate follow-up), 12 months (T3 - final follow-up)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07577089, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.

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