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NCT03477669: Colic
Infantile Colic: Study of the Efficacy of Lactobacillus GG (ATCC 53103) Plus Chamomile in Breastfeeding Infants
NA trial testing chamomile/probiotic arm in Infantile Colic in 1 participant. Terminated before completion.
25 February 2019
Quick facts
| Lead sponsor | University of Nebraska |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 1 |
| Start date | 18 May 2018 |
| Primary completion | 25 February 2019 |
| Estimated completion | 25 February 2019 |
| Sites | 1 location across United States |
Drugs / interventions tested
- chamomile/probiotic arm
- Placebo of chamomile/probiotic arm
Conditions studied
- Infantile Colic — all drugs for Infantile Colic →
Sponsor
University of Nebraska
Who can join
Adults 3 Weeks to 16 Weeks, any sex, with Infantile Colic. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The objective of this study is to determine the efficacy of a product combining the probiotic Lactobacillus GG and chamomile in treating infantile colic in exclusively breast fed infants. The study will be performed as a 4 week, placebo controlled, pilot trial with a one week run in period. Thirty subjects will be randomly assigned to each group for a total enrollment of 60 infants.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03477669
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Infantile Colic
Currently open trials in the same condition.
- NCT07148583 — BioAmicus Complete for Functional Gastrointestinal Symptoms in Infants Aged 0 to 24 Months · NA · recruiting
- NCT07190859 — Evaluating the Effect of Probiotic Limosilactobacillus Reuteri (L. Reuteri) on Crying and Fussing Time in Infants With C · NA · recruiting
- NCT05992493 — The Role of Human Milk Oligosaccharides and Microbiomes on Infantile Colic and Atopic Dermatitis in Term Infants · active not recruiting
Other University of Nebraska trials
Trials by the same sponsor.
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- NCT07207850 — Parents Helping Parents for Youth Vaping Cessation · NA · not yet recruiting
- NCT07237269 — Abi/Pred + ADT vs ADT in PSMA-Positive, Conventionally Node-Negative Prostate Cancer · Phase 2 · 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 NCT03477669 (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 University of Nebraska
- Last refreshed: 25 August 2023
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/NCT03477669.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing