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NCT05512234
Effect of Probiotic Limosilactobacillus Reuteri (L. Reuteri) on Crying Time in Infants With Colic
NA trial testing L. reuteri in Colic, Infantile in 102 participants. Currently enrolling.
30 October 2025
Quick facts
| Lead sponsor | BioGaia AB |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 102 |
| Start date | 13 July 2022 |
| Primary completion | 30 October 2025 |
| Estimated completion | 30 October 2025 |
| Sites | 2 locations across Sweden, Ireland |
Drugs / interventions tested
- L. reuteri — full drug profile →
- Placebo
Conditions studied
- Colic, Infantile — all drugs for Colic, Infantile →
Sponsor
BioGaia AB — full company profile →
Who can join
Adults 3 Weeks to 8 Weeks, any sex, with Colic, Infantile. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a double-blind, multi-center, randomized, placebo-controlled, parallel-group study in infants with colic with the primary objective to evaluate crying time.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05512234
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of L. reuteri
Trials testing the same drug.
- NCT07190859 — Evaluating the Effect of Probiotic Limosilactobacillus Reuteri (L. Reuteri) on Crying and Fussing Time in Infants With C · NA · recruiting
- NCT06462651 — Effect of Probiotic Limosilactobacillus Reuteri (L. Reuteri) on Crying and Fussing Time in Infants With Colic · NA · completed
- NCT04537494 — PRobiotics for EVEry Newborn Trial · NA · completed
- NCT04304014 — Assessment of the Impact of Type of Probiotic, Delivery Type and Feeding Type on Baby's Microbiota After Dysbiotic Deliv · NA · completed
- NCT02422082 — The Effect of Lactobacillus Reuteri ATCC PTA 6475 on Volumetric Bone Mineral Density in Patients With Osteopenia · NA · completed
Other recruiting trials for Colic, Infantile
Currently open trials in the same condition.
- NCT07254520 — The Effects of Reiki Therapy in Infants With Colic · NA · recruiting
- NCT06031025 — Prevalence and Natural History of Functional Gastrointestinal Disorders Among At-risk Infants. · recruiting
Other BioGaia AB trials
Trials by the same sponsor.
- NCT07190859 — Evaluating the Effect of Probiotic Limosilactobacillus Reuteri (L. Reuteri) on Crying and Fussing Time in Infants With C · NA · recruiting
- NCT06462651 — Effect of Probiotic Limosilactobacillus Reuteri (L. Reuteri) on Crying and Fussing Time in Infants With Colic · NA · completed
- NCT05044949 — Study Evaluating the Safety and Tolerability of a Probioitc · NA · completed
- NCT04692506 — Study Evaluating the Safety and Tolerability · NA · completed
- NCT04577625 — Effect of Probiotics on Testosterone in Men · 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 NCT05512234 (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 BioGaia AB
- Last refreshed: 22 September 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/NCT05512234.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing