Effects of Vivatlac Baby on Crying Behavior of Colicky Babies

NCT04487834 | Completed Phase 2 Results

• 1 other identifier: Kalisz 2020-01
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 2

Brief Summary

Open trial with two parallel arms, assessing the effects of Simethicone and Vivatlac Baby in babies diagnosed for infantile colic.

Conditions

Infantile Colic

Outcome Measures

Primary Outcomes (3)

• Number of Participants With a Reduction of Days Crying Equal or More Than 50 Percent From Baseline

  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.

  Three weeks

• Number of Participants With a Reduction of Average Duration of Evening Crying Equal or More Than 50 Percent

  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.

  Three weeks

• Number of Participants With a Reduction of Average Number of Crying Phases Per Day Equal or More Than 50 Percent

  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.

  Three weeks

Study Arms (2)

Simethicone Solution

ACTIVE COMPARATOR

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.

Drug: Simethicone Solution

Vivatlac Baby

EXPERIMENTAL

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.

Dietary Supplement: Vivatlac Baby

Interventions

Simethicone Solution DRUG

Oral daily treatment for four weeks

Also known as: Simethicone

Simethicone Solution

Vivatlac Baby DIETARY_SUPPLEMENT

Oral daily treatment for four weeks

Also known as: Multistrain Synbiotic

Vivatlac Baby

Eligibility Criteria

• Age: 3 Weeks - 6 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• diagnosed for infantile colic according to Wessel's criteria

You may not qualify if:

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

Sponsors & Collaborators

• The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz: lead

Study Sites (2)

GP Practice Pro Familia

Koziegłowy, 62028, Poland

Location

Medical University in Poznań

Poznan, 61701, Poland

Location

Related Publications (2)

• Piatek J, Krauss H, Ciechelska-Rybarczyk A, Bernatek M, Wojtyla-Buciora P, Sommermeyer H. In-Vitro Growth Inhibition of Bacterial Pathogens by Probiotics and a Synbiotic: Product Composition Matters. Int J Environ Res Public Health. 2020 May 11;17(9):3332. doi: 10.3390/ijerph17093332.

  PMID: 32403297 BACKGROUND

• Piatek J, Bernatek M, Krauss H, Wojciechowska M, Checinska-Maciejewska Z, Kaczmarek P, Sommermeyer H. Effects of a nine-strain bacterial synbiotic compared to simethicone in colicky babies - an open-label randomised study. Benef Microbes. 2021 Jun 15;12(3):249-257. doi: 10.3920/BM2020.0160. Epub 2021 Mar 26.

  PMID: 33765904 DERIVED

Related Links

• In-Vitro Growth Inhibition of Bacterial Pathogens by Probiotics and a Synbiotic: Product Composition Matters

MeSH Terms

Conditions

Colic

Interventions

Simethicone

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Dimethylpolysiloxanes; Silicones; Siloxanes; Organosilicon Compounds; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Limitations and Caveats

A limitation of the study is the use of parental diaries to measure infants' crying behavior. Using paper diaries is not without problems. Nevertheless, it has been shown that paper diary recordings of common infant behavior can provide reasonably good estimates of durations, while behavioral frequencies may be underestimated. Another major limitation of the study is that medication was not blinded.

Results Point of Contact

• Title: Jacek Piatek
• Organization: Calisia University, Kalisz, Poland

drpiatek@interia.eu

+48883389788

Study Officials

• Hanna Krauss, Prof.

  University of Applied Sciences in Kalisz, Poland

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2020
• First Posted: July 27, 2020
• Study Start: April 16, 2020
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: November 22, 2023
• Results First Posted: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

PL (2)