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NCT06720805
Pentabiocel in Pediatric IBS
NA trial testing Pentabiocel in Irritable Bowel Syndrome (IBS) in 56 participants. Not yet recruiting.
31 July 2025
Quick facts
| Lead sponsor | University of Roma La Sapienza |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 56 |
| Start date | 1 December 2024 |
| Primary completion | 31 July 2025 |
| Estimated completion | 31 December 2025 |
| Sites | 4 locations across Italy |
Drugs / interventions tested
- Pentabiocel — full drug profile →
- Placebo
Conditions studied
- Irritable Bowel Syndrome (IBS) — all drugs for Irritable Bowel Syndrome (IBS) →
- Pediatrics — all drugs for Pediatrics →
Sponsor
University of Roma La Sapienza
Who can join
Adults 4 to 17, any sex, with Irritable Bowel Syndrome (IBS) or Pediatrics. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Irritable Bowel Syndrome (IBS) is a common gastrointestinal disorder characterized by chronic abdominal pain and altered bowel habits, including diarrhea, constipation, or a combination of both. It is estimated to affect about 10-20% of the global population, with a higher prevalence among children and adolescents. The pathophysiology of IBS is multifactorial and involves alterations in the gut microbiota, visceral hypersensitivity, and abnormal gastrointestinal motility. Probiotics, defined as live microorganisms that provide health benefits when administered in adequate amounts, have emerged as a potential therapeutic option for IBS due to their ability to modulate the gut microbiota and exert anti-inflammatory and immunomodulatory effects. Several studies have shown the beneficial effects of probiotics in adult IBS patients; however, few studies have been conducted in the pediatric population. Thus, the investigators designed a randomized, double-blind, placebo-controlled, parallel-arm study evaluating the efficacy and safety of a 12-week probiotic treatment with a blend of 5 strains of lactic acid bacteria and bifidobacteria in pediatric patients with Irritative Bowel syndrome.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06720805
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Related trials
Other trials of Pentabiocel
Trials testing the same drug.
- NCT03857360 — Effectiveness of PENTABIOCEL in Clinical and Laboratory Recovery of Children With Celiac Disease · NA · completed
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 University of Roma La Sapienza trials
Trials by the same sponsor.
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- NCT07520968 — ABX Versus CHX in NSPT: a RCT · NA · active not recruiting
- NCT07109596 — Integration of Clinical, Biological and Psycho-social Variables for a Gender-sensitive Frailty Prediction · recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06720805 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Roma La Sapienza
- Last refreshed: 6 December 2024
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/NCT06720805.
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