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NCT06381193
Study for the Management of Chronic and Functional Constipation Through the Intake of Probiotics and Prebiotics
NA trial testing Probiotic in Functional Constipation in 80 participants. Completed in 10 July 2023.
10 July 2023
Quick facts
| Lead sponsor | Centros de Investigación de Nutrición y Salud |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 80 |
| Start date | 3 March 2023 |
| Primary completion | 10 July 2023 |
| Estimated completion | 10 July 2023 |
| Sites | 1 location across Spain |
Drugs / interventions tested
- Probiotic
- Prebiotic — full drug profile →
- Probiotic + Prebiotic
- Placebo
Conditions studied
- Functional Constipation — all drugs for Functional Constipation →
Sponsor
Centros de Investigación de Nutrición y Salud
Who can join
Adults 18 to 65, any sex, with Functional Constipation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this clinical trial is to learn if supplementation with prebiotics and/or probiotics can lead to an improvement in symptoms of patients with functional constipation. The main objectives are: * To evaluate the effect of the dietary supplements on the bowel frequency movements in patients with chronic functional constipation, after 8 weeks. * To evaluate the stool consistency after 8 weeks (Bristol scale). * To evaluate the quality of life scale score for patients with Constipation (CVE20 and GSRS scales), after 8 weeks. Participants are randomized into the following groups: * Group A: 20 assigned to probiotic + placebo * Group B: 20 assigned to prebiotic + placebo * Group C: 20 assigned to probiotic + prebiotic * Group D: 20 assigned to the placebo + placebo Participants took 4 units of product per day (2 of each assigned product) for 2 months.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Supplementation with probiotics, prebiotics, and synbiotics in patients with chronic functional constipation: a randomized, double-blind, placebo-controlled pilot clinical trial.
Terrén Lora A, Penadés BF, López Oliva S, Arponen S, et al · · 2024 · cited 4× · PMID 39530075 · DOI 10.1093/gastro/goae101 -
Microbiota-immune crosstalk in the regulation of intestinal motility in constipation.
Pan Z, Zhang T, Ren Z, Zhang H, et al · · 2026 · PMID 42094762 · DOI 10.3389/fmicb.2026.1828926
Verify or expand the search:
- PubMed search for NCT06381193
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Probiotic
Trials testing the same drug.
- NCT07529457 — Akk09 in Adults With Constipation · NA · not yet recruiting
- NCT07507955 — Probiotics for Constipation Relief in Adults · NA · not yet recruiting
- NCT07462481 — Probiotic Improve Constipation · NA · recruiting
- NCT07511855 — Stress-buffering and Sleep Disturbance-resilient Effects of a Dual Bifidobacterium Longum Combination Under Short-term T · Phase 2 · not yet recruiting
- NCT07474064 — Probiotics Combined With Targeted Therapy Plus Immunotherapy in Bladder-Preserving Setting for Patients With MIBC · Phase 2 · not yet recruiting
Other recruiting trials for Functional Constipation
Currently open trials in the same condition.
- NCT07148583 — BioAmicus Complete for Functional Gastrointestinal Symptoms in Infants Aged 0 to 24 Months · NA · recruiting
- NCT07091084 — A Study of Herbal Supplements in Cancer Survivors With Constipation · NA · recruiting
- NCT06534996 — A Single Arm Pilot Study of the Chinese Herbal Medicine Formula (SCD-2101) for the Functional Constipation in the Elderl · NA · recruiting
- NCT04918329 — Functional Digestive Disorders Observatory · recruiting
- NCT04547816 — Efficacy of Conservative Treatment of Functional Defecatory Disorders in Females With Pelvic Organ Prolapse · Phase 3 · recruiting
Other Centros de Investigación de Nutrición y Salud trials
Trials by the same sponsor.
- NCT05389761 — Fibromyalgia Treatment With Enzyme DAO · NA · completed
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 NCT06381193 (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 Centros de Investigación de Nutrición y Salud
- Last refreshed: 24 April 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/NCT06381193.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing