Trials / Completed
CompletedNCT04487834
Effects of Vivatlac Baby on Crying Behavior of Colicky Babies
Effects of Simethicone and Vivatlac Baby in Infantile Colic
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 87 (actual)
- Sponsor
- The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz · Academic / Other
- Sex
- All
- Age
- 3 Weeks – 6 Weeks
- Healthy volunteers
- Not accepted
Summary
Open trial with two parallel arms, assessing the effects of Simethicone and Vivatlac Baby in babies diagnosed for infantile colic.
Detailed description
Babies aged 3 to 6 weeks will be diagnosed for infantile colic using the Wessel's criteria. Study design will be open label with two parallel arms (Simethicone and Vivatlac Baby). Vivatlac Baby is a synbiotic product containing probiotic bacteria (six lactobacilli and 3 bifidobacteria). Effects of treatments on crying behavior will be assessed by using parental 24h paper diaries.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Simethicone Solution | Oral daily treatment for four weeks |
| DIETARY_SUPPLEMENT | Vivatlac Baby | Oral daily treatment for four weeks |
Timeline
- Start date
- 2020-04-16
- Primary completion
- 2020-06-30
- Completion
- 2020-06-30
- First posted
- 2020-07-27
- Last updated
- 2023-11-22
- Results posted
- 2023-11-22
Locations
2 sites across 1 country: Poland
Source: ClinicalTrials.gov record NCT04487834. Inclusion in this directory is not an endorsement.