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NCT05524649: BABYCARE
Effect of Probiotics on Infant's Fecal Microbiota Composition
NA trial testing Food Supplement 1 in Microbial Colonization in 120 participants. Currently enrolling.
31 August 2025
Quick facts
| Lead sponsor | AB Biotics, SA |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | other |
| Enrollment | 120 |
| Start date | 1 June 2022 |
| Primary completion | 31 August 2025 |
| Estimated completion | 31 December 2025 |
| Sites | 2 locations across Spain, Mexico |
Drugs / interventions tested
- Food Supplement 1
- Food Supplement 2
- Placebo
Conditions studied
- Microbial Colonization — all drugs for Microbial Colonization →
Sponsor
AB Biotics, SA — full company profile →
Who can join
Adults 1 Day to 90 Days, any sex, with Microbial Colonization. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Randomized clinical trial to evaluate the effect of two probiotic strains which belong to Bifidobacterium Longum and Pediococcus pentosaceus species on fecal microbiota composition in healthy infants. Secondary outcomes comprise evaluation of anthropometric growth, digestive tolerance, sleeping habits, incidence of functional gastrointestinal disorders, incidence of gastrointestinal and respiratory infections, allergic reactions and safety and tolerability of the product.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05524649
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Microbial Colonization
Currently open trials in the same condition.
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- NCT06938386 — Pilot Haskap Metabolite Timing Project · NA · active not recruiting
- NCT06920641 — Effects of Tagatose on Glycemic Response and Gastrointestinal Microbiota in Healthy Adults · NA · recruiting
- NCT06541808 — Balance, Autonomic Response, and Sensory Modulation to Dosage of Mechanical Vagal Stimulation in Healthy Adults · NA · 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
- NCT05279534 — Efficacy and Safety of L. Plantarum and P. Acidilactici in Children With Upper Respiratory Tract Infections · NA · terminated
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 NCT05524649 (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 AB Biotics, SA
- Last refreshed: 11 February 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/NCT05524649.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing