Effects of Vivatlac Baby on Crying Behavior of Colicky Babies

Phase 2

Completed

• Conditions: Infantile Colic
• Interventions: Drug: Simethicone Solution; Dietary Supplement: Vivatlac Baby

• Registration Number: NCT04487834
• Lead Sponsor: The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz

Brief 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.

Study Timeline

• Study Start: 2020-04-16
• Primary Completion: 2020-06-30
• Study Completion: 2020-06-30
• Study First Submitted: 2020-07-22
• Study First Submitted QC: 2020-07-22
• Study First Posted: 2020-07-27
• Results First Submitted: 2023-01-31
• Status Verified: 2023-11
• Results First Submitted QC: 2023-11-20
• Last Update Submitted: 2023-11-20
• Results First Posted: 2023-11-22
• Last Update Posted: 2023-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

Inclusion Criteria

• diagnosed for infantile colic according to Wessel's criteria

Exclusion Criteria

• previous treatment with probiotic or synbiotic
• previous treatment with antibiotics

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Simethicone Solution	Simethicone Solution	Treatment with simethicone (Espumisan®, 100 mg/ml, Berlin-Chemie / Menarini Polska Sp z o.o., Warsaw, Poland) for four weeks. Simethicone was administered 3-6 times per day with each treatment comprising 6 drops of the 100 mg/ml emulsion.
Vivatlac Baby	Vivatlac Baby	Treatment with one stick pack of the multi-strain synbiotic (Vivatlac® Baby, Vivatrex GmbH, Rees, Germany) per day for four weeks. Each stick pack of Vivatlac® Baby contains a total of 10\^9 colony forming units (CFU) with equal CFU amounts of the following probiotic bacteria: L. acidophilus LA-14, L. casei R0215; L. paracasei Lpc-3; L. plantarum Lp-115; L. rhamnosus GG, L. salivarius Ls-33, B. lactis Bl-04, B. bifidum R0071, B. longum R0175 and 1.43 g of the prebiotic fructooligosaccharides.

Primary Outcome Measures

Name	Time	Method
Number of Participants With a Reduction of Average Duration of Evening Crying Equal or More Than 50 Percent	Three weeks	Measurement of average duration of evening crying during last three weeks before enrollment and before the end of treatment. Treatment success was determined by calculation the percentage of patients for whom the measurement was reduced by the respective treatment by equal or more than 50 percent, compared to the value at the time of enrollment.
Number of Participants With a Reduction of Days Crying Equal or More Than 50 Percent From Baseline	Three weeks	Measurement of days of crying during last three weeks before enrollment and before the end of treatment. Treatment success was determined by calculation the percentage of patients for whom the measurement was reduced by the respective treatment by equal or more than 50 percent, compared to the value at the time of enrollment.
Number of Participants With a Reduction of Average Number of Crying Phases Per Day Equal or More Than 50 Percent	Three weeks	Measurement average number of crying phases per day during last three weeks before enrollment and before the end of treatment. Treatment success was determined by calculation the percentage of patients for whom the measurement was reduced by the respective treatment by equal or more than 50 percent, compared to the value at the time of enrollment.

Trial Locations

Locations (2)

Medical University in Poznań; 🇵🇱 Poznan, Poland

GP Practice Pro Familia; 🇵🇱 Koziegłowy, Poland