Last reviewed · How we verify
NCT05565612
Clinical Trial to Evaluate the Effect of a Probiotic Mixture on Signs and Symptoms of Irritable Bowel Syndrome
NA trial testing Normodigest Classic in IBS - Irritable Bowel Syndrome in 26 participants. Completed in 1 March 2024.
26 December 2023
Quick facts
| Lead sponsor | Laboratorio Industrial de Herbodietetica Aplicada S.L |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 26 |
| Start date | 10 October 2022 |
| Primary completion | 26 December 2023 |
| Estimated completion | 1 March 2024 |
| Sites | 1 location across Spain |
Drugs / interventions tested
- Normodigest Classic
- Placebo
Conditions studied
- IBS - Irritable Bowel Syndrome — all drugs for IBS - Irritable Bowel Syndrome →
Sponsor
Laboratorio Industrial de Herbodietetica Aplicada S.L
Who can join
Adults 18 to 65, any sex, with IBS - Irritable Bowel Syndrome. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The clinical trial has a randomized, double-blind and placebo-controlled design, in which the effect of a probiotic mix wants to be evaluated, with a treatment of 12 weeks, in the evolution of the symptoms of Irritable Bowel Syndrome. The 12 weeks of the treatment are structured in four in-person visits: Visit 1 (initial; week 0), Visit 2 (halfway; week 4), Visit 3 (halfway; week 8) and Visit 4 (final; week 12).
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Comparative Analysis of Gut Microbiota in Patients with Irritable Bowel Syndrome and Healthy Controls.
Sánchez-Pellicer P, Álamo-Marzo JM, Martínez-Villaescusa M, Núñez-Delegido E, et al · · 2025 · cited 3× · PMID 40004729 · DOI 10.3390/jcm14041198
Verify or expand the search:
- PubMed search for NCT05565612
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for IBS - Irritable Bowel Syndrome
Currently open trials in the same condition.
- NCT06993272 — Relaxation Music for Chronic Pain · NA · active not recruiting
- NCT06684470 — Novel Pilot Study to Treat Symptoms of IBS With Diarrhea Using Combination Therapy of a Low-FODMAP Diet and a Neuromodul · EARLY_PHASE1 · recruiting
- NCT06117865 — Digital Treatment of Irritable Bowel Syndrome (IBS) · NA · active not recruiting
- NCT06215222 — Capsule Microbiota Sampling in IBS/Functional Gastrointestinal Disease · recruiting
- NCT05815602 — Ebastine Versus Mebeverine in IBS Patients · Phase 3 · recruiting
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 NCT05565612 (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 Laboratorio Industrial de Herbodietetica Aplicada S.L
- Last refreshed: 28 March 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/NCT05565612.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing