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NCT03444311
Combined Nutritional Therapies for the Treatment of Ulcerative Colitis
NA trial testing A: 1 dosis in Colitis, Ulcerative in 12 participants. Terminated before completion.
2 July 2019
Quick facts
| Lead sponsor | AB Biotics, SA |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 12 |
| Start date | 8 March 2018 |
| Primary completion | 2 July 2019 |
| Estimated completion | 2 July 2020 |
| Sites | 1 location across Spain |
Drugs / interventions tested
- A: 1 dosis
- B: 2 dosis
Conditions studied
- Colitis, Ulcerative — all drugs for Colitis, Ulcerative →
Sponsor
AB Biotics, SA — full company profile →
Who can join
Adults 18 to 65, any sex, with Colitis, Ulcerative. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Ulcerative colitis (UC) is an entity of complex etiology where environmental, genetic and intestinal microflora-related factors trigger and perpetuate a chronic inflammation of the gastrointestinal tract. It is suspected that an alteration in primary intestinal microbial colonization (dysbiosis) could trigger, or at least contribute to, said oversized immune response. The hypothesis is that the administration of a series of fibers, could improve the bacterial diversity and repair the dysbiosis that has been seen in patients affected by ulcerative colitis, improving the clinical evolution of it. The primary objective of the present study is to know the impact on the microbiota of patients with UC in remission derived from the administration of dietary fibers. The RETOS study is a pilot project in which a population of patients with UC is tested for the effect on the composition of the microbiota that would have the administration of various combinations of fibers, in addition to the tolerability and acceptance by the patient. The clinical applicability derived from this intervention would be to improve the diversity of intestinal flora of patients with ulcerative colitis.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
β-Glucan Metabolic and Immunomodulatory Properties and Potential for Clinical Application.
Murphy EJ, Rezoagli E, Major I, Rowan NJ, et al · · 2020 · cited 121× · PMID 33322069 · DOI 10.3390/jof6040356
Verify or expand the search:
- PubMed search for NCT03444311
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Colitis, Ulcerative
Currently open trials in the same condition.
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- NCT07242248 — A Study to Observe Real-world Evidence of Guselkumab Treatment in Participants With Ulcerative Colitis and Crohn's Disea · recruiting
- NCT07196748 — A Protocol of Icotrokinra Therapy in Adult and Adolescent Participants With Moderately to Severely Active Ulcerative Col · Phase 3 · recruiting
- NCT07102368 — A Study to Generate Real-world Evidence of Guselkumab Effectiveness in Inflammatory Bowel Disease in Germany · recruiting
- NCT06651281 — Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Coli · Phase 3 · recruiting
Other AB Biotics, SA trials
Trials by the same sponsor.
- NCT07193927 — Investigation of the Efficacy of a Probiotic Mixture in Moderate Metabolic Dysfunction-Associated Steatotic Liver Diseas · Phase 2 · not yet recruiting
- NCT06604234 — Impact of a Probiotic Combination on Quality of Life and Symptoms in Peri- and Postmenopausal Women · NA · completed
- NCT06193096 — Impact of a Probiotic-based Formula on Digestive Symptoms and Mood in Ultra Marathon Runners · NA · completed
- NCT05688397 — Evaluation of the Vaginal Colonization of Two New Lactobacillus Strains After Oral Administration in Healthy Volunteers · NA · completed
- NCT05524649 — Effect of Probiotics on Infant's Fecal Microbiota Composition · NA · 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 NCT03444311 (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 AB Biotics, SA
- Last refreshed: 8 July 2020
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/NCT03444311.
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