NCT05453084 (AF_IBS) is a NA clinical trial of Exercise Program in Irritable Bowel Syndrome (IBS), sponsored by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis.

What drugs are being tested in NCT05453084?

Interventions in NCT05453084: Exercise Program.

What condition does NCT05453084 study?

NCT05453084 studies Irritable Bowel Syndrome (IBS).

Is NCT05453084 still recruiting?

NCT05453084 is currently completed. Last updated 1 May 2025.

Last reviewed 2025-05-01 · How we verify

NCT05453084: AF_IBS

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Exercise and Irritable Bowel Syndrome (IBS)

Completed NA Last updated 1 May 2025

What this trial tests

NA trial testing Exercise Program in Irritable Bowel Syndrome (IBS) in 137 participants. Completed in 30 December 2024.

Timeline

2 May 2022

Primary endpoint
31 December 2023

30 December 2024

Quick facts

Lead sponsor	Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	137
Start date	2 May 2022
Primary completion	31 December 2023
Estimated completion	30 December 2024
Sites	1 location across Italy

Drugs / interventions tested

Exercise Program

Conditions studied

Irritable Bowel Syndrome (IBS) — all drugs for Irritable Bowel Syndrome (IBS) →

Sponsor

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Who can join

Adults 18 to 65, any sex, with Irritable Bowel Syndrome (IBS). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Specific Aim 1: As shown in the literature, exercise can be a useful tool for treating and improving functional GI disorders. Therefore, the aim is to estimate the effectiveness of an exercise intervention on IBS symptoms as measured by a reduction of at least 50 score points on the IBS- Symptom Severity Scale (IBS-SSS) questionnaire.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

The Impact of a Twelve-Week Moderate Aerobic Exercise Program on Gastrointestinal Symptom Profile and Psychological Well-Being of Irritable Bowel Syndrome Patients: Preliminary Data from a Southern Italy Cohort.
Riezzo G, Prospero L, D'Attoma B, Ignazzi A, et al · · 2023 · cited 13× · PMID 37629401 · DOI 10.3390/jcm12165359
Enhanced Physical Capacity and Gastrointestinal Symptom Improvement in Southern Italian IBS Patients following Three Months of Moderate Aerobic Exercise.
Bianco A, Russo F, Franco I, Riezzo G, et al · · 2023 · cited 10× · PMID 37959251 · DOI 10.3390/jcm12216786
Effect of a 12-Week Walking Program Monitored by Global Physical Capacity Score (GPCS) on Circulating Cell-Free mtDNA and DNase Activity in Patients with Irritable Bowel Syndrome.
Chimienti G, Russo F, Bianco A, Maqoud F, et al · · 2024 · cited 7× · PMID 38673878 · DOI 10.3390/ijms25084293
Beyond Nutritional Treatment: Effects of Fitwalking on Physical Capacity and Intestinal Barrier Integrity in BMI-Stratified IBS Patients.
Bianco A, Russo F, Prospero L, Riezzo G, et al · · 2024 · cited 4× · PMID 39683574 · DOI 10.3390/nu16234181
The impact of locus of control on somatic and psychological profiles of patients with irritable bowel syndrome engaging in aerobic exercise.
Prospero L, Riezzo G, D'Attoma B, Ignazzi A, et al · · 2025 · cited 2× · PMID 39893252 · DOI 10.1038/s41598-025-88466-7
StepFit-18K: Improving Irritable Bowel Syndrome (IBS) Symptoms with a Simple, Structured Walking Intervention.
Franco I, Bianco A, Prospero L, Riezzo G, et al · · 2024 · cited 2× · PMID 39597828 · DOI 10.3390/jcm13226684

Verify or expand the search:

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Other recruiting trials for Irritable Bowel Syndrome (IBS)

Currently open trials in the same condition.

NCT07481422 — Safety and Efficacy of Lyophilized Faecal Microbiota Transplantation Via Capsules in Treatment of Irritable Bowel Syndro · Phase 1, PHASE2 · recruiting
NCT07261826 — Real-World Study on Fecal Microbiota Transplantation: Long-Term Effectiveness and Safety Statistics · recruiting
NCT07000227 — Mechanism of FODMAP Restriction on FGID Patients · NA · recruiting
NCT06647043 — Evaluate the Effect of Synbiotics in Irritable Bowel Syndrome · NA · recruiting
NCT06668922 — Irritable Bowel Syndrome and Control Volunteers: Diet Challenge · NA · recruiting

Other Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis trials

Trials by the same sponsor.

NCT07497789 — SMYD3-Driven Metabolic Rewiring in Colorectal Liver Metastases · not yet recruiting
NCT07412444 — EVOO and Metabolic Liver Health in MASLD · NA · not yet recruiting
NCT07153458 — Identification of New Non-invasive, Predictive, and Diagnostic Biomarkers for Colorectal Cancer · recruiting
NCT06931925 — Recall of a Cohort of Subjects in the Mediterranean Area. Monitoring of Liver Diseases (NUTRIHEP 3). · not yet recruiting
NCT06830317 — Study on the Efficacy of Endoscopic Radiofrequency Treatment in Reducing the Need for Blood Transfusions in GAVE · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05453084 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Last refreshed: 1 May 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05453084.

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